Dye Free Ibuprofen IBUPROFEN BREEDEN BROTHERS, LLC FDA Approved Uses _ temporarily relieves minor aches and pains due to: _ backache _ muscular aches _ minor pain of arthritis _ headache _ menstrual cramps _ toothache _ the common cold _ temporarily reduces fever Drug Facts (continued)
FunFoxMeds box
Substance Ibuprofen
Route
ORAL
Applications
ANDA075139

Drug Facts

Composition & Profile

Active Ingredients
Active in gredient (in each white tablet) Ibuprofen USP 200 mg (NSAID)*
Inactive Ingredients
Inactive ingredients corn starch colloidal silicon dioxide hypromellose lactose anhydrous magnesium stearate microcrystalline cellulose polydextrose polyethylene glycol povidone sodium starch glycolate stearic acid triacetin
Strengths
200 mg
Treats Conditions
Uses Temporarily Relieves Minor Aches And Pains Due To Backache Muscular Aches Minor Pain Of Arthritis Headache Menstrual Cramps Toothache The Common Cold Temporarily Reduces Fever Drug Facts Continued
Pill Appearance
Shape: round Color: white Imprint: 44;438

Identifiers & Packaging

Container Type UNKNOWN
UNII
WK2XYI10QM
Packaging

PRINCIPAL DISPLAY PANEL b+b better by giving PRINCIPAL DISPLAY PANEL b+b better by giving

Package Descriptions
  • PRINCIPAL DISPLAY PANEL b+b better by giving PRINCIPAL DISPLAY PANEL b+b better by giving

Overview

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

Indications & Usage

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

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 Drug Facts (continued)

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. Drug Facts (continued) 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 problems, such as heartburn _ you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke _ you are taking a diuretic _ you have problems or serious side effects from taking pain relievers or fever reducers Ask a doctor or pharmacist before use if you are _ under a doctor's care for any serious condition _ taking any other drug Drug Facts (continued) _ taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin When using this product _ take with food or milk if stomach upset occurs 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 _ slurred speech _ leg swelling _ trouble breathing _ weakness in one part or side of body _ pain gets worse or lasts more than 10 days _ fever gets worse or lasts more than 3 days _ any new symptoms appear _ redness or swelling is present in the painful area Drug Facts (continued) If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely 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 (1-800-222-1222) right away.
Purpose

Purpose Pain reliever/fever reducer *nonsteroidal anti-inflammatory drug

Do Not Use

Do not use _ if you have 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

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 _ slurred speech _ leg swelling _ trouble breathing _ weakness in one part or side of body _ pain gets worse or lasts more than 10 days _ fever gets worse or lasts more than 3 days _ any new symptoms appear _ redness or swelling is present in the painful area Drug Facts (continued)

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 (1-800-222-1222) right away.

Questions

Questions or comments? 1-800-901-2420 Dist. by Breeden Brothers, LLC Nashville, TN 37219


Similar Drugs

Related medications based on brand, generic name, substance, active ingredients.

View all similar drugs →