Ibuprofen IBUPROFEN PLD ACQUISITIONS LLC DBA AVMA PHARMA SOLUTIONS 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
FunFoxMeds bottle
Substance Ibuprofen
Route
ORAL
Applications
ANDA076460

Drug Facts

Composition & Profile

Active Ingredients
Active Ingredient (in each caplet) Ibuprofen USP 200 mg (NSAID)* *nonsteroidal anti-inflammatory drug Purpose Pain reliever/ fever reducer
Inactive Ingredients
Inactive Ingredients carnauba wax croscarmellose sodium FD&C yellow #6 aluminium lake hypromellose microcrystalline cellulose polydextrose polyethylene glycol pregelatinized starch silicon dioxide stearic acid titanium dioxide.
Strengths
200 mg
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: capsule Color: orange Imprint: 55

Identifiers & Packaging

Container Type BOTTLE
UPC
0359726185004 0359726185011 0359726185103
UNII
WK2XYI10QM
Packaging

Principal Display Panel Ibuprofen Tablets USP, 200 mg Pain Reliever/ Fever Reducer (NSAID) Coated Caplets** **(Capsule-Shaped Tablets) DO NOT USE IF TAMPER-EVIDENT SEAL UNDER BOTTLE CAP IMPRINTED WITH "SEALED FOR YOUR PROTECTION" IS BROKEN OR MISSING Manufactured by: Avema Pharma Solutions 10400 NW 29th Terrace Miami, FL 33172; Product Label Ibuprofen 200 mg orange Caplets Ibuprofen 200 mg orange Caplets Ibuprofen 200 mg orange Caplets Ibuprofen 200 mg orange Caplets Avema Pharma Solutions Avema Pharma Solutions Avema Pharma Solutions Avema Pharma Solutions

Package Descriptions
  • Principal Display Panel Ibuprofen Tablets USP, 200 mg Pain Reliever/ Fever Reducer (NSAID) Coated Caplets** **(Capsule-Shaped Tablets) DO NOT USE IF TAMPER-EVIDENT SEAL UNDER BOTTLE CAP IMPRINTED WITH "SEALED FOR YOUR PROTECTION" IS BROKEN OR MISSING Manufactured by: Avema Pharma Solutions 10400 NW 29th Terrace Miami, FL 33172
  • Product Label Ibuprofen 200 mg orange Caplets Ibuprofen 200 mg orange Caplets Ibuprofen 200 mg orange Caplets Ibuprofen 200 mg orange Caplets Avema Pharma Solutions Avema Pharma Solutions Avema Pharma Solutions Avema Pharma Solutions

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 older: take 1 caplet every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 caplet, 2 caplets may be used do not exceed 6 caplets 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 rash blisters skin reddening If an allergic reaction occurs, stop use an 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 oder have had stomach ulcers or bleeding problems take blood thinning (anticoagulant) or steroid drug take other drugs containing prescritpion or non-prescription NSAIDs (aspirin, ibuprofen, naproxen, or others) take more or for a longer time than directed. have 3 or more alcoholic drinks every day while using this prdouct Do not use if you 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 problems or serious side effects from taking pain relievers or fever reducers you have a history of stomach problems such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you have asthma you are taking a diuretic. Ask a doctor or pharmacist before use if you are under a doctor's care for any serious condition taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin taking any other drug. When using this product take with food or milk if stomach upset occurs the risk of heart attack or stroke may increase if you use more than directed or for longer than directed. Stop use and ask a doctor if You experience any of the following signs of stomach bleeding: feel faint have bloody or black stools vomit blood have stomach pain that does not get better pain gets worse or last more than 10 days fever gets worse or last more than 3 days redness or swelling is present in the painful area any new symptoms appear If pregnant or breast-feeding ask a health professional before use. It is especially important not to use ibuprofen druing the last 3 months of pegnancy unless defintely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. 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) Directions do not take more than directed the smallest effective dose should be used adults and children 12 years and older: take 1 caplet every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 caplet, 2 caplets may be used do not exceed 6 caplets in 24 hours, unless directed by a doctor children under 12 years : ask a doctor Other information store between 20 o - 25 o C (68 o - 77 o F)
Purpose

Purpose Pain reliever/ fever reducer

Do Not Use

Do not use if you ever had an allergic reaction to 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 the risk of heart attack or stroke may increase if you use more than directed or for longer than directed.

Stop Use & Ask a Doctor

Stop use and ask a doctor if You experience any of the following signs of stomach bleeding: feel faint have bloody or black stools vomit blood have stomach pain that does not get better pain gets worse or last more than 10 days fever gets worse or last 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. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)

Questions

Questions or comments? Call 1-877-753-3935 Monday-Friday 9AM-5PM EST


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