Ibuprofen Oral 100 mg/5mL
Ibuprofen Oral · SUSPENSION · Bryant Ranch Prepack
Ibuprofen Oral is a suspension containing ibuprofen oral at 100 mg/5mL, taken oral. Manufactured by Bryant Ranch Prepack.
Key Facts
- Brand Name
- Ibuprofen Oral
- Generic Name
- Ibuprofen Oral
- NDC Code (Product)
63629-8540- Manufacturer
- Bryant Ranch Prepack
- Strength
- 100 mg/5mL
- Dosage Form
- SUSPENSION
- Route
- ORAL
- Marketing Status
- Application #
- ANDA210602
- Drug Class
- Nonsteroidal Anti-inflammatory Drug [EPC]
- Marketing Start
- 11/23/2018
Recall History
Tris Pharma Inc.
Superpotent Drug: recalled lots may have higher concentration of ibuprofen.
Taro Pharmaceuticals U.S.A., Inc.
Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.
Tris Pharma Inc.
Superpotent Drug: recalled lots may have higher concentration of ibuprofen.
Central Shared Services dba Parallon
CGMP Deviation: Discoloration; Product fails specification for appearance/color. A complaint was received regarding an abnormal appearance of children's ibuprofen suspension.
STRIDES PHARMA INC
Presence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product.
Tris Pharma Inc.
Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled.
Taro Pharmaceuticals U.S.A., Inc.
Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.
Tris Pharma Inc.
Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled.
Tris Pharma Inc.
Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled.
Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
Uses temporarily: relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache reduces fever
Dosage & Administration
Directions this product does not contain directions or complete warnings for adult use do not give more than directed shake well before using mL = milliliter find right dose on chart. if possible, use weight to dose; otherwise use age. use only enclosed dosing cup. Do not use any other dosing device. if needed, repeat dose every 6-8 hours do not use more than 4 times a day replace original bottle cap to maintain child resistance Dosing Chart Weight (lb) Age (yr) Dose (mL)* under 24 under 2 years ask a doctor 24-35 lbs 2-3 years 5 mL 36-47 lbs 4-5 years 7.5 mL 48-59 lbs 6-8 years 10 mL 60-71 lbs 9-10 years 12.5 mL 72-95 lbs 11 years 15 mL *or as directed by a doctor
Warnings
Warnings Allergy alert : Ibuprofen may cause severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives facial swelling asthma (wheezing) shock skin reddening rash blisters. If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning : This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if your child : has had stomach ulcers or bleeding problems takes a blood thinning (anticoagulant) or steroid drug takes other drug containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) takes more or for a longer time than directed Heart attack and stroke warning : NSAIDs except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed. Sore throat warning : Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult doctor promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by a doctor. Do not use if the child has ever …
Frequently Asked Questions
What is Ibuprofen Oral used for?
Ibuprofen Oral contains Ibuprofen Oral. It is a suspension taken oral. Consult your doctor for specific uses.
Is Ibuprofen Oral a controlled substance?
Ibuprofen Oral is not classified as a controlled substance by the DEA.
What is the generic name for Ibuprofen Oral?
The generic name for Ibuprofen Oral is Ibuprofen Oral. There are 1 other brand versions of Ibuprofen Oral.
What is the NDC code for Ibuprofen Oral 100 mg/5mL?
The NDC (National Drug Code) for Ibuprofen Oral 100 mg/5mL is 63629-8540, listed by Bryant Ranch Prepack.
Other Ibuprofen Oral Dosages
- Ibuprofen Oral100 mg/5mL72162-1911
- Ibuprofen Oral100 mg/5mL70677-1116
- Ibuprofen Oral100 mg/5mL69230-311
- Ibuprofen Oral100 mg/5mL70677-0150
- Ibuprofen Oral100 mg/5mL63629-8851
- Ibuprofen Oral100 mg/5mL50090-4129
- Ibuprofen Oral100 mg/5mL63629-8853
- Ibuprofen Oral100 mg/5mL70677-1118
- Ibuprofen Oral100 mg/5mL63629-8852
- Ibuprofen Oral100 mg/5mL68071-1628
Other Ibuprofen Brands
See all →Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)