Ibuprofen 800 mg/1
Ibuprofen · TABLET · Asclemed USA, Inc.
Ibuprofen is a tablet containing ibuprofen at 800 mg/1, taken oral. Manufactured by Asclemed USA, Inc..
Key Facts
- Brand Name
- Ibuprofen
- Generic Name
- Ibuprofen
- NDC Code (Product)
76420-577- Manufacturer
- Asclemed USA, Inc.
- Strength
- 800 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- ANDA213794
- Drug Class
- Nonsteroidal Anti-inflammatory Drug [EPC]
- Marketing Start
- 05/08/2020
Recall History
Attix Pharmaceuticals
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
American Health Packaging
Labeling: Label Mix-Up: Some cartons of AHP Ibuprofen Tablets, USP, 600mg, lot #142588 that contain blister cards filled with Ibuprofen tablets, 600mg drug product, were found to be mis-labeled with blister card print identifying the product as AHP Oxcarbazepine Tablets, 300mg, lot #142544
Spirit Pharmaceuticals, LLC
CGMP deviations: Ibuprofen is being recalled in response to previous recall
Tris Pharma Inc.
Superpotent Drug: recalled lots may have higher concentration of ibuprofen.
Time-Cap Laboratories, Inc.
Presence of foreign tablets/capsules: Ibuprofen Tablets USP, 600 mg bottles were found to contain some Ibuprofen Tablets USP 800 mg.
Dr. Reddy's Laboratories, Inc.
Failed Tablet/Capsule Specifications
Family Dollar Stores, Llc.
CGMP deviation: product outside labeled storage temperature requirements.
Mcneil Consumer Healthcare, Div Of Mcneil-ppc, Inc.
Presence of Foreign Substance: process-related particulates which may be associated with the raw materials were observed
Time-Cap Laboratories, Inc.
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
Marksans Pharma Inc.
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
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: headache toothache backache menstrual cramps the common cold muscular aches minor pain of arthritis temporarily reduces fever
Dosage & Administration
Directions do not take more than directed the smallest effective dose should be used adults and children 12 years and over: take 1 tablet every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 tablet, 2 tablets may be used do not exceed 6 tablets in 24 hours, unless directed by a doctor children under 12 years: ask a doctor
Warnings
Warnings Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: rash facial swelling asthma (wheezing) hives skin reddening shock 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 you: take more or for a longer time than directed take a blood thinning (anticoagulant) or steroid drug have had stomach ulcers or bleeding problems have 3 or more alcoholic drinks every day while using this product are age 60 or older take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] 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. Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery Ask a doctor before use if stomach bleeding warning applies to you you have a history of stomach pr…
Frequently Asked Questions
What is Ibuprofen used for?
Ibuprofen contains Ibuprofen. It is a tablet taken oral. Consult your doctor for specific uses.
Is Ibuprofen a controlled substance?
Ibuprofen is not classified as a controlled substance by the DEA.
What is the generic name for Ibuprofen?
The generic name for Ibuprofen is Ibuprofen. There are 6 other brand versions of Ibuprofen.
What is the NDC code for Ibuprofen 800 mg/1?
The NDC (National Drug Code) for Ibuprofen 800 mg/1 is 76420-577, listed by Asclemed USA, Inc..