Ibuprofen IBUPROFEN TOPCO ASSOCIATES, LLC FDA Approved Uses temporarily relieves minor aches and pains due to: headache muscular aches menstrual cramps backache toothache the common cold minor pain of arthritis temporarily reduces fever
Generic: IBUPROFEN
Mfr: TOPCO ASSOCIATES, LLC FDA #25 OTC
FunFoxMeds box
Substance Ibuprofen
Route
ORAL
Applications
ANDA075139
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each orange caplet) Ibuprofen USP 200 mg (NSAID)* *nonsteroidal anti-inflammatory drug
Inactive Ingredients
Inactive ingredients carnauba wax colloidal silicon dioxide corn starch FD&C yellow #6 aluminum lake hypromellose lactose anhydrous magnesium stearate microcrystalline cellulose polydextrose polyethylene glycol sodium starch glycolate stearic acid titanium dioxide
Strengths
200 mg
Treats Conditions
Uses Temporarily Relieves Minor Aches And Pains Due To Headache Muscular Aches Menstrual Cramps Backache Toothache The Common Cold Minor Pain Of Arthritis Temporarily Reduces Fever
Pill Appearance
Shape: oval Color: orange Imprint: 44;393

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UPC
0036800495807
UNII
WK2XYI10QM
Packaging

Principal Display Panel +TopCare ® health NDC 36800-993-06 COMPARE TO MOTRIN ® IB CAPLETS ACTIVE INGREDIENT † Ibuprofen Tablets USP, 200 mg • PAIN RELIEVER • FEVER REDUCER (NSAID) 200 CAPLETS TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007 ©TOPCO LNKA0521 QUESTIONS? 1-888-423-0139 [email protected] www.topcarebrand.com Visit here for more information: http://topbrnds.com/48ZZSN † This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Motrin® IB Caplets. 50844 REV1221C39306 TopCare 44-393 TopCare 44-393

Package Descriptions
  • Principal Display Panel +TopCare ® health NDC 36800-993-06 COMPARE TO MOTRIN ® IB CAPLETS ACTIVE INGREDIENT † Ibuprofen Tablets USP, 200 mg • PAIN RELIEVER • FEVER REDUCER (NSAID) 200 CAPLETS TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007 ©TOPCO LNKA0521 QUESTIONS? 1-888-423-0139 [email protected] www.topcarebrand.com Visit here for more information: http://topbrnds.com/48ZZSN † This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Motrin® IB Caplets. 50844 REV1221C39306 TopCare 44-393 TopCare 44-393

Overview

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

Indications & Usage

Uses temporarily relieves minor aches and pains due to: headache muscular aches menstrual cramps backache toothache the common cold 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 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 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 have had stomach ulcers or bleeding problems are age 60 or older take a blood thinning (anticoagulant) or steroid drug take more or for a longer time than directed 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 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 you are taking a diuretic you have problems or serious side effects from taking pain relievers or fever reducers you have a history of stomach problems, such as heartburn stomach bleeding warning applies to you you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke 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 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 you have symptoms of heart problems or stroke: chest pain weakness in one part or side of body leg swelling trouble breathing slurred speech 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 If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen at 20 weeks or later in 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 right away.
Purpose

Purpose Pain reliever/fever reducer

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 have bloody or black stools vomit blood have stomach pain that does not get better you have symptoms of heart problems or stroke: chest pain weakness in one part or side of body leg swelling trouble breathing slurred speech 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. In case of overdose, get medical help or contact a Poison Control Center right away.

Storage & Handling

Other information store between 20°-25°C (68°-77°F) avoid excessive heat 40°C (104°F) use by expiration date on package

Questions

Questions or comments? Call 1-888-423-0139


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