Ibuprofen (ibuprofen 200 mg) Dailymed

Generic: ibuprofen is used for the treatment of Arthritis, Juvenile Arthritis, Rheumatoid Asthma Bursitis Dysmenorrhea Fever Gout Inflammation Menorrhagia Osteoarthritis Pain Pain, Postoperative Pregnancy Trimester, Third Pregnancy, Abdominal Premenstrual Syndrome Rhinitis Spondylitis, Ankylosing Bronchial Hyperreactivity

IMPRINT: 114 SHAPE: round
COLOR: brown

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Active Ingredient(s)

Ibuprofen 200 mg (NSAID)*

* nonstreoidal anti-inflammatory drug

Purpose

Pain reliever / fever reducer

Use(s)

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

Warnings

Allergy alert: Ibuprofen may cause a severe allergy reaction, especially in people allergic to aspirin. Symptoms may include:

hives

facial swelling

asthma (wheezing)

shock

skin reddening

rash

bulers

If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains a 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: NSAID's 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 ibuprofen or any other pain reliever/fever reducer

right before or after heart surgery

Ask A Doctor Before Use If

• you have problems or serious side effects from taking pain relievers or fever reducers • the 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

Ask A Doctor Or Pharmacist Before Use If You Are

taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin

under a doctor’s care for any serious condition

taking any other drug

When Using This Product

take with food or milk if stomach upset occurs

Stop Use And Ask 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

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 a 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 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

Other Information

store between 20-25 ⁰C (68-77 ⁰F).

do not use if carton is opened. do not use if seal under bottle cap imprinted with” SEALED for YOUR PROTECTION” is broken or missing.

see end panel for lot number and expiration date

Inactive Ingredients

colloidal silicon dioxide, croscarmellose sodium, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, titanium dioxide. Questions or Comments? Call 1-877-290-4008 Manufactured for: Time-Cap Labs, Inc. 7 Michael Avenue, Farmingdale, NY 11735, USA Manufactured by: Marksans Pharma Ltd. Plot No. L-82, L-83 Verna Industrial Estate Verna, Goa-403722, India

Storage

Principal Display Panel

NDC 25000-114-03, Ibuprofen Tablets USP, 200mg

30 counts Bottle Label

NDC 25000-114-03, Ibuprofen Tablets USP, 200mg

30 counts Carton Label

NDC 25000-117-03, Ibuprofen Tablets USP, 200mg (Caplets)

30 counts Bottle Label

NDC 25000-117-03, Ibuprofen Tablets USP, 200mg (Caplets)

30 counts Carton Label

NDC 25000-114-70, Ibuprofen Tablets USP, 200mg

500 counts Bottle Label

NDC 25000-114-14, Ibuprofen Tablets USP, 200mg

1000 counts Bottle Label

NDC 25000-114-71, Ibuprofen Tablets USP, 200mg

1000 counts (PET) Bottle Label

NDC 25000-117-14, Ibuprofen Tablets USP, 200mg

1000 counts Bottle Label (Caplets)

NDC 25000-117-69, Ibuprofen Tablets USP, 200mg (Caplets)

300 counts Bottle Label

NDC 25000-114-02, Ibuprofen Tablets USP, 200mg

24 counts Bottle Label

NDC 25000-114-02, Ibuprofen Tablets USP, 200mg

24 counts Carton Label

NDC 25000-117-02, Ibuprofen Tablets USP, 200mg (Caplets)

24 counts Bottle Label

NDC 25000-117-02, Ibuprofen Tablets USP, 200mg (Caplets)

24 counts Carton Label

DISCLAIMER:

"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."

"Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service."

"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."

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adults and children 12 years and older	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