Ibuprofen
FDA Label NDC 65692-0412

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Raining Rose Inc. for the product Ibuprofen (NDC 65692-0412). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding drug factsactive ingredient, purpose, keep out of reach of children, uses, warnings  allergy alert:, do not use, ask a doctor before use if, ask a doctor or pharmacist before use if you are, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Drug Factsactive Ingredient

Active ingredient (in each tablet)

Ibuprofen (NSAID)* 200 mg

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

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.

Uses

• Temporarily relieves minor aches and pains associated with • headache • toothache • backache • menstrual cramps • common cold • muscular aches • minor arthritis pain • Temporarily reduces fever.

Warnings  Allergy Alert:

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

• hives • skin reddening • facial swelling • rash • asthma (wheezing) • blister • shock 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 thinner (anticoagulant) or steroid drug • take other drugs containing prescription or nonprescription NSAIDs (asprin, 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.

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, or kidney disease • you are taking a diuretic • you have problems or serious side effects from taking pain relivers or fever reducers • you have asthma

Ask A Doctor Or Pharmacist Before Use If You Are

• taking aspirin for heart attack or stroke, because ibuprofen may decrease the benefit or aspirin • taking any other drug • under a doctor's care for any serious condition

When Using This Product

• the risk of a heart attack or stroke may increase if you use more than directed or longer than directed • 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 blackstools • have stomach pain that does not get better • 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 or unexpected symptoms appear.

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 specifically directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Directions

do not use 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: Do not give to children under 12 years of age.

Inactive Ingredients:

carnauba wax, corn starch, fumed silia gel, hypromellose, lactose,  magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, red irion oxide, sodium starch glycolate, stearic acid, titanium dioxide.

Other Information

• read all product information before using.

Store at 68-77°F (20-25°C) • Avoid ecessive heat, above 104°F (40°C).

Ibuprofen Product Label

IBUPROFEN

12 Ibuprofen Tablets USP, 200 mPain Reliever/Fever Reducer (NSAID)

LOT CODE:

EXP DATE:

OPEN HERE TO VIE COMPLETE PRODUCT INFORMATION

Do not use if safety seal is broken.

TAMPER EVIDENT: DO NOT USE IF THIS SAFETY SEAL AROUND CAP IS BROKEN OR MISSING

TEAR HERE TO OPEN

Dist. By Raining Rose, Inc. Cedar Rapids, IA 52403

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