Ibuprofen IBUPROFEN AMNEAL PHARMACEUTICALS OF NEW YORK LLC FDA Approved Uses temporarily relieves minor aches and pains due to: headache muscular aches minor pain of arthritis toothache backache the common cold menstrual cramps temporarily reduces fever

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each tablet) Ibuprofen USP 200 mg (NSAID)** **nonsteroidal anti-inflammatory drug
Inactive Ingredients
Inactive ingredients Brown Tablets: colloidal silicon dioxide croscarmellose sodium hypromellose iron oxide red magnesium stearate maltodextrin microcrystalline cellulose polydextrose pregelatinized starch stearic acid talc titanium dioxide triglycerides Orange Tablets: colloidal silicon dioxide croscarmellose sodium FD&C Yellow #6 hypromellose magnesium stearate maltodextrin microcrystalline cellulose polydextrose pregelatinized starch stearic acid talc titanium dioxide triglycerides White Tablets: colloidal silicon dioxide croscarmellose sodium magnesium stearate microcrystalline cellulose polyethylene glycol polyvinyl alcohol pregelatinized starch stearic acid talc titanium dioxide
Strengths
200 mg
Quantities
250 tablets
Treats Conditions
Uses Temporarily Relieves Minor Aches And Pains Due To Headache Muscular Aches Minor Pain Of Arthritis Toothache Backache The Common Cold Menstrual Cramps Temporarily Reduces Fever
Pill Appearance
Shape: round Color: brown Imprint: IP;462

Identifiers & Packaging

Container Type UNKNOWN
UPC
0353746462022 0353746458025 0353746460028
UNII
WK2XYI10QM
Packaging

PACKAGE LABEL. PRINCIPAL DISPLAY PANEL NDC 53746-462-02 Ibuprofen Tablets USP, 200 mg 250 Tablets Amneal Pharmaceuticals LLC 1; PACKAGE LABEL. PRINCIPAL DISPLAY PANEL NDC 53746-460-02 Ibuprofen Tablets USP, 200 mg 250 Tablets Amneal Pharmaceuticals LLC 1; PACKAGE LABEL. PRINCIPAL DISPLAY PANEL NDC 53746-458-02 Ibuprofen Tablets USP, 200 mg 250 Tablets Amneal Pharmaceuticals LLC 1

Package Descriptions
  • PACKAGE LABEL. PRINCIPAL DISPLAY PANEL NDC 53746-462-02 Ibuprofen Tablets USP, 200 mg 250 Tablets Amneal Pharmaceuticals LLC 1
  • PACKAGE LABEL. PRINCIPAL DISPLAY PANEL NDC 53746-460-02 Ibuprofen Tablets USP, 200 mg 250 Tablets Amneal Pharmaceuticals LLC 1
  • PACKAGE LABEL. PRINCIPAL DISPLAY PANEL NDC 53746-458-02 Ibuprofen Tablets USP, 200 mg 250 Tablets Amneal Pharmaceuticals LLC 1

Overview

Uses temporarily relieves minor aches and pains due to: headache muscular aches minor pain of arthritis toothache backache the common cold menstrual cramps temporarily reduces fever

Indications & Usage

Uses temporarily relieves minor aches and pains due to: headache muscular aches minor pain of arthritis toothache backache the common cold menstrual cramps 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 & Precautions
Warnings Allergy alert: Ibuprofen may cause a 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 you: are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] have 3 or more alcoholic drinks every day while using this product take 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.
Purpose

Purpose Pain reliever/fever reducer

Do Not Use

Do not use if you have ever had an allergic reaction to ibuprofen or any other pain reliever/fever reducer right before or after heart surgery

When Using

When using this product take with food or milk if stomach upset occurs

Stop Use & Ask a Doctor

Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better you have symptoms of heart problems or stroke: chest pain trouble breathing weakness in one part or side of body slurred speech leg swelling pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present in the painful area any new symptoms appear

Keep Out of Reach of Children

KEEP OUT OF REACH OF CHILDREN Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Questions

Questions or Comments? Call 1-877-835-5472 Monday through Friday 9AM - 5PM EST. *Amneal Pharmaceuticals is not affiliated with the owner of the trademark Motrin IB ® Distributed By: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 10-2022-00


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