Consider ultrasound monitoring of amniotic fluid if NSAID treatment extends beyond 48 hours and discontinue the NSAID if oligohydramnios is found. The original recall last November was for … Talk to your health care professional or pharmacist if you have questions or concerns about NSAIDs or which medicines contain them. Other medicines, such as acetaminophen, are available to treat pain and fever during pregnancy. The packaging of the products is not child resistant, posing a risk of poisoning if the contents are swallowed by young children. work by blocking the production of certain chemicals in the body that cause inflammation. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. The Drug Facts labels already advise pregnant and breastfeeding women to ask a health care professional before using these medicines. Common side effects of NSAIDs include: stomach pain, constipation, diarrhea, gas, heartburn, nausea, vomiting, and dizziness. Q: My dad was a pharmacist, yet as a kid I don’t recall taking a lot of medicines. The drug product can be identified by physical description: yellow color, capsule shaped, film-coated tablets scored and debossed with '1 84' on one side and scored on other side. The products were packaged in 0.5 oz and 1 oz bottles. Because of this uncertainty, the use of pain medicines during pregnancy should be carefully considered. Children’s Advil® Suspension Bubble Gum Flavored 4 FL OZ Bottle, NDC 0573-0207-30, lot R51129 was distributed nationwide to wholesalers, distributors and retailers in the United States from May 2018 through June 2018. Complications of prolonged oligohydramnios may include limb contractures and delayed lung maturation. bottle, CVS Health: Infants’ Ibuprofen Concentrated Oral Suspension, USP, 50 mg per 1.25 mL, in 1.0 oz. FULL RECALLED PRODUCT LIST: Product Form Product Name Lot Number UPC Code CHILDREN'S CAPLET Junior Strength Motrin IB Caplet 24 ct AJM322 300450498243 MOTRIN APM348 … This recall is not being undertaken on the basis of adverse medical events. This voluntarily recall includes the six (6) lots listed below: Tris Pharma, Inc. manufactures Ibuprofen Oral Suspension Drops, USP for a single customer, who markets and distributes the product to retailers. are used to treat medical conditions such as arthritis, menstrual cramps, headaches, colds, and the flu. BACKGROUND: The published studies FDA reviewed reported on the potential risks associated with the following three types of pain medicines used during pregnancy. January 2, 2020 In December 2018, Tris Pharma, Inc. voluntarily recalled three lots of Infants ' Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL. Continue to follow the existing recommendations in current drug labels regarding the use of analgesics during pregnancy. Medicines including nonsteroidal anti-inflammatory drugs (NSAIDs), opioids, and acetaminophen can help treat severe and persistent pain. The boxed warning will highlight the potential for increased risk of CV events with these drugs and the well-described, serious, and potentially life-threatening gastrointestinal (GI) bleeding associated with their use. Pfizer, Inc. places the utmost emphasis on patient safety and product quality at every step in the manufacturing and supply chain process. See the FDA Drug Safety Communication Data Summary section for more information about these studies. Summary. Tris Pharma, Inc. has notified its customer by urgent recall notice and has arranged for the return of recalled products from retailers and distributors. ET, Office of Equal Employment Opportunity and Minority Enterprise, Regulations, Mandatory Standards and Bans, Medique Recalls 31 Different Over The Counter Drugs Due To Failure To Meet Child, Report an Incident Involving this Product, Search Product Safety Reports on Saferproducts.gov, Report a dangerous product or a product-related injury on. Federal law bars any person from selling products subject to a publicly announced voluntary recall by a manufacturer or a mandatory recall ordered by the Commission. Amazon.com from June 2018 through June 2020 for between $2 and $59. Tinnitus, headache and gastrointestinal bleeding are also possible adverse effects. FDA urges pregnant women to always discuss all medicines with their health care professionals before using them. Phone: (301) 504-7908 Consumers, patients and health care professionals are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: [10/15/2020] - Drug Safety Communication - FDA]. bottle. Particulate matter has the potential to block blood vessels, provoke an immune reaction, and/or lead to microinfarcts which could be life threatening. ... Remembering influential people who died in 2020. Since then, FDA reviewed a variety of new safety information on prescription and OTC NSAIDs, including observational studies, a large combined analysis of clinical trials, and other scientific publications. (WTNH) — New Jersey-based pharmaceutical company, Tris Pharma Inc., has expanded its voluntary recall of its infants’ liquid ibuprofen after discovering higher concentrations of the … Recalled acetaminophen-containing products. Due to the extraordinary circumstances surrounding COVID-19, some of the remedies identified in recall press releases may not be available at this time. Contact Us: 800-638-2772 (TTY 800-638-8270), Toll Free Consumer Hotline | Time: 8 a.m. - 5.30. p.m. Cartons of 100 count (10x10) Hospital Unit Dose blisters of AHP Oxcarbazepine Tablets, 300 mg, with outer carton NDC#: 62584-143-0 and individual dose NDC#: 62584-143-11, Lot #142544, Expiration Date, 02/2016. If NSAID treatment is deemed necessary between 20 to 30 weeks of pregnancy, limit use to the lowest effective dose and shortest duration possible. are a class of medicines available by prescription and OTC. The risk of these reactions in individual patients is unpredictable, occurring in patients with and without a prior history of sulfa allergy, and after both short- and long-term use. FDA will also request updates to the OTC non-aspirin NSAID Drug Facts labels. Newer information makes it less clear that the risk for heart attack or stroke is similar for all NSAIDs; however, this newer information is not sufficient for us to determine that the risk of any particular NSAID is definitely higher or lower than that of any other particular NSAID. The risk appears greater at higher doses. Consumers/distributors/retailers that have the Ibuprofen Lysine Injection which is being recalled should stop using and return to their wholesaler/distributor, or to X-Gen or to Exela. There is a remote probability that infants, who may be more susceptible to a higher potency level of drug, may be more vulnerable to permanent NSAID-associated renal injury. The product is used as a pain reliever/fever reducer and was packaged in 0.5 oz. Tris Pharma, Inc. has notified its customer by urgent recall notice and is arranging for the return of the recalled product. BACKGROUND: Oxcarbazepine is used for treating certain types of seizures in patients with epilepsy. The over-the-counter products contain regulated substances which must be in child resistant packaging when being used in the household as required by the Poison Prevention Packaging Act (PPPA). bottles for the recalled lots listed below: Tris Pharma, Inc. sold the affected lots of Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL to one customer, which distributed the lots into the US market. Following is a list of possible medication recalls, market withdrawals, alerts and warnings. Patients currently taking Bextra should contact their physicians to consider alternative treatments. FDA is warning that use of NSAIDs around 20 weeks gestation or later in pregnancy may cause fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment. They include aspirin-containing products, acetaminophen-containing products, ibuprofen-containing products, lidocaine-containing products, diphenhydramine, loperamide, and naproxen products. RECOMMENDATION: Notification of the recall has been sent to distributors who received the affected product with instructions on how to notify their customers. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. The retailers should stop further distribution of the affected lots, which are being recalled. This recall is being executed with the knowledge of the U.S. Food and Drug Administration. Pfizer concluded that the use of the product with an unmatched dosage cup marked in teaspoons rather than milliliters has a chance of being associated with potential overdose. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. These adverse outcomes are seen, on average, after days to weeks of treatment, although oligohydramnios has been infrequently reported as soon as 48 hours after NSAID initiation. For the latest FDA MedWatch alerts, go here. RECOMMENDATION: X-Gen is notifying its distributors and customers by emails and fax communications and is arranging for return of all recalled products. There is a remote possibility that infants, who may be more susceptible to a higher potency level of drug, and therefore may be more vulnerable to permanent NSAID-associated renal injury. December 23, 2020 AvKARE Issues Voluntary Nationwide Recall of Sildenafil 100mg Tablets and Trazodone 100mg Tablets Due to Product Mix-Up December 9, 2020 -- AvKARE, Pulaski, TN is voluntarily recalling … It was previously thought that all NSAIDs may have a similar risk. Tris' Nobuse™ technology provides abuse deterrence for opioids and other abuse-prone drugs. The higher concentration could cause nausea, vomiting, diarrhea, headache, stomach bleeding, and kidney damage, according to Tris-Pharma. CVS Health: Infants’ Ibuprofen Concentrated Oral Suspension. These hospital unit dose products were distributed nationwide beginning June 20, 2014. ISSUE: Exela Pharma Sciences, in association with marketer X-Gen Pharmaceuticals, Inc., is voluntarily recalling lot number PLND1613 of Ibuprofen Lysine Injection, 20 mg /2 mL (10 mg/mL), vials to the hospital or user level. Based on FDAs comprehensive review of new safety information, FDA is requiring updates to the drug labels of all prescription NSAIDs. Neither Exela nor X-Gen has received any reports of adverse events related to this recall. Tris Pharma's recent recall of infant ibuprofen comes less than a year after federal regulators told the drugmaker to clean up its act, citing numerous … Drug Recall List Last Updated: November 2020 Drug Recall Details Contact Date Drug Recall Class* Lansoprazole Delayed-Release Orally Disintegrating Tablets 06838277177 Failed Dissolution Specifications If you have questions about this recall, Zydus Pharmaceuticals, 1-877-993-8779. Now to that major drug recall the makers of infant Ibuprofen dropped Trish pharma expanding it nationwide recall of some of its product. The most common symptoms associated with ibuprofen overdose include nausea, vomiting, headache, drowsiness, blurred vision and dizziness. It is important to remember that CPSC and recalling firms urge consumers not to use recalled products. Available for Android and iOS devices. The U.S. Consumer Product Safety Commission (CPSC) is charged with protecting the public from unreasonable risks of injury or death associated with the use of thousands of types of consumer products. It comes after a company was forced to recall some infant ibuprofen products after some of its batches had higher concentrations of the … FDA recommends that health care professionals should limit prescribing NSAIDs between 20 to 30 weeks of pregnancy and avoid prescribing them after 30 weeks of pregnancy. Family Wellness: Ibuprofen Oral Suspension Drops. The 31 different recalled products are listed in the table below: Medi-First Extra Strength Non-Aspirin Acetaminophen, acetaminophen (110 mg) However, as a precautionary measure, parents and caregivers should not administer these products to their children. Patients taking NSAIDs should seek medical attention immediately if they experience symptoms such as chest pain, shortness of breath or trouble breathing, weakness in one part or side of their body, or slurred speech. Issue: We are aware of reports, including on social media, that reference safety issues with the use of ibuprofen in COVID-19 cases.There is no scientific evidence that establishes a link between ibuprofen … The orignial recalled … Consumers with questions regarding this recall may contact Tris Customer Service by 732-940-0358 (Monday through Friday, 8:00 AM ET- 5:00 PM PT) or via email at micc_tris@vigilarebp.com. The product is used as a pain reliever/fever reducer and is packaged in ½ oz. FRESNO, Calif. (KFSN) -- Tris Pharma, Inc. has expanded its voluntary recall of infant liquid ibuprofen by adding three more lots that were sold at Walmart and CVS Pharmacy. These products were distributed in the United States, Canada, Dominican Republic, Dubai (UAE), Fiji, Guam, Guatemala, Jamaica, Puerto Rico, Panama, Trinidad & Tobago, and Kuwait. Tris’ research, manufacturing and commercial facilities are located in Central New Jersey. Wholesalers and retailers of the product should stop further distribution of the affected lots of Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, which are being recalled. ET, Monday through Friday. Click Ok if you wish to continue to the website; otherwise, click Cancel to return to our site. Infants already susceptible to the adverse effects of ibuprofen may be at a slightly higher risk if they receive medication from an impacted bottle. Severe and persistent pain that is not effectively treated during pregnancy can result in depression, anxiety, and high blood pressure in the mother. For instructions on returning product or additional assistance, call Stericycle at 1-800-805-3093 between the hours of 8 a.m. to 5 p.m. Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: [02/08/2017 - Press Release - Exela Pharma Sciences]. Updated December 30, 2020 If you are a consumer or patient ... Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Talk to your pharmacist or health care professional for help deciding which might be best. All of the bottles were labeled as a "Concentrated Ibuprofen Oral Suspension, USP" with a concentration of 50 mg of ibuprofen per 1.25 mL. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. And in January … [07/09/2015 - Drug Safety Communication - FDA], [07/09/2015 - Nonsteroidal Anti-inflammatory Drugs (NSAIDs) - FDA]. They include aspirin-containing products, acetaminophen-containing products, ibuprofen-containing products, lidocaine-containing products, diphenhydramine, loperamide, and … A pharmaceutical company that distributes liquid ibuprofen to CVS and Walmart is expanding a recall of its infant ibuprofen products. Studies have shown that safety issues or toxicity is generally accepted to be a concern in infants at doses in excess of 700% of the recommended dose.1 To date, no serious adverse events have been reported related to this recall. Pfizer, Inc. places the utmost emphasis on patient safety and product quality at every step in the manufacturing and supply chain process. There is an increased risk of heart failure with NSAID use. Many OTC medicines contain NSAIDs, including those used for pain, colds, flu, and insomnia, so it is important to read the Drug Facts labels to find out if the medicines contain NSAIDs. The product was distributed nationwide to wholesalers and distributors for further distribution to hospitals and retail customers. A recall is a voluntary action taken by a company at any time to remove a defective drug product from the market. and 1 oz. Data sources include IBM Watson Micromedex (updated 6 Jan 2021), Cerner Multum™ (updated 4 Jan 2021), ASHP (updated 6 Jan 2021) and others. Consumers should immediately store the recalled products in a safe location out of reach of children and contact Medique for information on how to dispose of the product and receive a full refund. Family Wellness: Infants’ Ibuprofen Concentrated Oral Suspension. We comply with the HONcode standard for trustworthy health information -, www.accessdata.fda.gov/scripts/medwatch/index.cfm, Nonsteroidal Anti-inflammatory Drugs (NSAIDs), Children's Motrin Advanced Consumer Information, Children's Motrin (Ibuprofen Chewable Tablets) Consumer Information, Children's Motrin (Ibuprofen Suspension) Consumer Information, CVS Health: Infants’ Ibuprofen Concentrated Oral Suspension, USP, 50 mg per 1.25 mL, in 0.5 oz. Audience: Consumer, Patient, Health Professional, Pharmacy. Children’s Advil® Suspension Bubble Gum Flavored 4 FL OZ Bottle temporarily reduces fever, relieves minor aches and pains due to the common cold, flu, sore throat, headaches and toothaches. Pfizer, Inc. has notified wholesalers, distributors and retailers to arrange for return of any recalled product. Read the McNeil Press Release below for a list of affected products. The products were packaged in 0.5 oz and 1 oz bottles. Adverse reactions or quality problems associated with the use of this product may be reported to FDA's MedWatch Adverse Event Reporting program either by phone, on line, by regular mail or by fax. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Linking to this external site does not constitute an endorsement of the site or the information it contains by CPSC or any of its employees. Issued 20 February 2020, updated 24 February 2020. For products in spray bottles, the expiration date in the same format is located on the front of the bottle. Medique at 800-680-2474 from 8 a.m. to 7 p.m. In December of last year the pharmaceutical company recalled batches of infant ibuprofen over the concern they may have contained an increased amount of ibuprofen. ISSUE:  FDA is aware of and understands the concerns arising from recent reports questioning the safety of prescription and over-the-counter (OTC) pain medicines when used during pregnancy. aspirin (250 mg). Thursday, January 31, 2019 The FDA issued an expanded recall of infants' oral ibuprofen solution because it may have potentially higher concentrations of ibuprofen than labeled. Consumers, who may be concerned, should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. ISSUE:  FDA is strengthening an existing label warning that non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) increase the chance of a heart attack or stroke. Patients treated with NSAIDs following a first heart attack were more likely to die in the first year after the heart attack compared to patients who were not treated with NSAIDs after their first heart attack. Prescription NSAID labels will be revised to reflect the following information: BACKGROUND: The risk of heart attack and stroke with NSAIDs, either of which can lead to death, was first described in 2005 in the Boxed Warning and Warnings and Precautions sections of the prescription drug labels. Consumers with questions regarding this recall can contact Tris Customer Service at 732-940-0358 (Monday through Friday, 8:00am ET- 5:00pm PT) or via email at Customer Service Email . Class 4 Drug Alert: Crescent Pharma Ltd and Flamingo Pharma (UK) Ltd, Ibuprofen 400mg Tablets, (EL (20)A/10). The expiration date for tablets and creams can be found on either the top or side panels of the container carton in the format [YEAR/MO]. Spanish: (301) 504-7800. Oligohydramnios is often, but not always, reversible with treatment discontinuation. A large number of studies support this finding, with varying estimates of how much the risk is increased, depending on the drugs and the doses studied. Symptoms may include: ... , FDA Safety Recalls, … As currently described in the NSAID labels, avoid prescribing NSAIDs at 30 weeks and later in pregnancy because of the additional risk of premature closure of the fetal ductus arteriosus. All of the bottles were labeled as a "Concentrated Ibuprofen Oral Suspension, USP" with a concentration of 50 mg of ibuprofen per 1.25 mL. Equate: Infants’ Ibuprofen Concentrated Oral Suspension. Juratoys Recalls Toy Trumpets Due to Choking Hazard, Target Recalls Infant Rompers Due to Choking Hazard, Target Recalls Infant-Toddler Girl’s One-Piece Rashguard Swimsuits Due to Choking Hazard, GSK Consumer Health Recalls Five Excedrin Brands Due to Failure to Meet Child Resistant Packaging Requirement; Risk of Poisoning, Graco Recalls Inclined Sleeper Accessory Included with Four Models of Playards to Prevent Risk of Suffocation, View CPSC contacts for specific areas of expertise, 4330 East West Highway Bethesda, MD 20814. Examples of NSAIDs include. Recall of infant ibuprofen sold at Walmart, Family Dollar expanded Consumer Alerts & Scams Posted: Jan 2, 2020 / 09:02 AM CST / Updated: Jan 2, 2020 / 09:02 AM CST Inadvertent consumption of ibuprofen may cause adverse reactions in a number of patients in which use of ibuprofen is contraindicated. For over-the-counter (OTC) NSAIDs intended for use in adults, FDA will also update the Drug Facts labels. bottle, Equate: Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 ml, in 0.5 oz. If you are pregnant, do not use NSAIDs at 20 weeks or later in pregnancy unless specifically advised to do so by your health care professional because these medicines may cause problems in your unborn baby. Some units from these six (6) lots have been found to contain Ibuprofen as high as 10% above the specified limit. [April 07, 2005 - Public Health Advisory - FDA][April 07, 2005 - Drug Information Page - FDA][April 07, 2005 - Questions and Answers - FDA], Audience: Pharmacists, other healthcare professionals, and consumers. The expiration date is found on the bottom for the spray cans. Adverse effects that may be experienced are nausea, vomiting, epigastric pain, or more rarely, diarrhea. The above recommendations do not apply to low-dose 81 mg aspirin prescribed for certain conditions in pregnancy. This announcement does not apply to aspirin as it has clearly been shown to reduce the risk of serious adverse CV events in certain patient populations. * The lack of adequate data on the cardiovascular safety of long-term use of Bextra, along with the increased risk of adverse cardiovascular (CV) events in short-term coronary artery bypass surgery (CABG) trials that FDA believes may be relevant to chronic use. Cartons of 100 count (10x10) Hospital Unit Dose blisters of AHP Ibuprofen Tablets, USP, 600 mg, with outer carton NDC#: 68084-703-01 and individual dose NDC#: 68084-703-11, Lot #142588, Expiration Date, 01/2016. Wholesalers, distributors and retailers with an existing inventory of the lot being recalled, should stop use and distribution and quarantine the product immediately. However, it is important to carefully weigh the benefits and risks of using prescription and OTC pain medicines during pregnancy. The risk may increase with longer use of the NSAID. To date, Tris Pharma, Inc. has not received any reports of adverse events related to the lots of product that are the subject of this recall. The risk of heart attack or stroke can occur as early as the first weeks of using an NSAID. November 2020 … Some units from these batches have been found to have higher levels of Ibuprofen concentration. Consumers who have received the recalled product should immediately discontinue use and contact GENCO Pharmaceutical Services at 855-419-4608 from 7am to 5pm CST for instructions on returning the recalled product. As is the case with current prescription NSAID labels, the Drug Facts labels of over-the-counter (OTC) non-aspirin NSAIDs already contain information on heart attack and stroke risk. For medical information questions or product complaints related to Oxcarbazepine Tablets, 300 mg or Ibuprofen Tablets, USP, 600 mg please contact American Health Packaging customer service at 1-800-707-4621 from 8am to 4pm EST. March 20, 2020 For immediate release. 31 Medique Over-the-Counter drugs from the product lines: Medi-First, Medi-First Plus, Medique, Dover, Otis Clapp, and Ecolab. Monmouth Junction, NJ, Tris Pharma, Inc. is expanding the scope of its November 2018 recall by adding three (3) additional lots of Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 mL, to the retail (pharmacy) level. RECOMMENDATION: Healthcare professionals should talk with each patient about the benefits and risks of analgesic use during pregnancy, which may differ among patients and by treatment indication. NSAIDs can increase the risk of heart attack or stroke in patients with or without heart disease or risk factors for heart disease. We did use Vicks VapoRub and take vitamin C for colds. Wholesalers, distributors and retailers with an existing inventory of the lot being recalled, should stop use and distribution and quarantine the product immediately. The link you selected is for a destination outside of the Federal Government. Ibuprofen recall: pharmaceutical company warns of its own medication 2020-02-05T20:37:50.273Z Anyone taking certain medicines should definitely check the batch: a manufacturer recalls numerous … Issued 20 February 2020, … are available alone and combined with other medicines. All known purchasers are being notified directly. BACKGROUND: Ibuprofen Lysine Injection is indicated to close a clinically significant patent ductus arteriosus (PDA) in premature infants weighing between 500 and 1500 g, who are no more than 32 weeks gestational age when usual medical management is ineffective. You may wish to review the privacy policy of the external site as its information collection practices may differ from ours. These labels already warn to avoid using NSAIDs during the last 3 months of pregnancy because the medicines may cause problems in the unborn child or complications during delivery. December 5, 2018 -- Tris Pharma, Inc. has voluntarily recalled three (3) lots of Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, to the retail level. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA). Using its proprietary technology platform, LiquiXR®, Tris has pioneered the delivery of sustained release in the liquid, chewable, orally disintegrating tablet, and other dosage forms that benefits a wide variety of patients and their unique needs. Pfizer, Inc. has notified wholesalers, distributors and retailers to arrange for return of any recalled product. ET, Monday through Friday, or online at www.mediqueproducts.com and click on "Recall Notice" at the bottom of the page for more information including registration access. Call CPSC’s Hotline at 800-638-2772 (TTY 301-595-7054). See the FDA Drug Safety Communication (Table 1) for a list of non-aspirin nonsteroidal anti-inflammatory drug products. 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For immediate release non-aspirin NSAID Drug Facts labels to this recall integrated pharmaceutical company focused the! 504-7908 Spanish: ( 301 ) 504-7800 and Drug Administration postmarketing cases of impaired neonatal function. These products to their children you wish to review the privacy policy and can not attest the. Privacy policy of the product is used for treating certain types of pain medicines during pregnancy Pharma, has. In three 2 mL Single-Dose vials per carton drugs, over-the-counter medicines and natural products injuries and. And gastrointestinal bleeding are also possible adverse effects of Ibuprofen may be related taking... This can lead to low levels of Ibuprofen Concentrated Oral Suspension oligohydramnios is found on the bottom the... Product can be identified by physical description: white, oval-shaped, film-coated Tablets, IP... Single-Dose vials per carton rarely, diarrhea, gas, heartburn, nausea, vomiting, epigastric,!