SPL v2
SPL
SPL Set ID eb0e3dcf-3c99-4c6e-b133-4299d855141b
Route
ORAL
Published
Effective Date 2015-04-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ibuprofen (200 1)
Inactive Ingredients
Silicon Dioxide Croscarmellose Sodium Ferric Oxide Red Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol 400 Polyvinyl Alcohol Starch, Corn Talc Titanium Dioxide

Identifiers & Packaging

Marketing Status
ANDA Active Since 2015-04-09

Description

ACTIVE INGREDIENT IN EACH TABLET- Ibuprofen 200 mg (NSAID)


Medication Information

Warnings and 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 • blisters If an allergic reaction occurs, stop use and seek medical help right away.

Stomach Bleeding Warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause 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 an NSAID [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.

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 use if you have: • problems or serious side effects from taking pain relievers or fever reducers • stomach problems that last or come back, such as heartburn, upset stomach, or stomach pain •

ulcers • bleeding problems • high blood pressure • heart disease, liver cirrhosis, or kidney disease • taken a diuretic • reached age 60 or older

Ask a doctor or pharmacist before use if you are: • taking any other drug containing an NSAID (prescription or nonprescription) • taking a blood thinning (anticoagulant) or steroid drug • 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 • long term continuous use may increase the risk of heart attack or stroke

Stop use and ask a doctor if: • you feel faint, vomit blood, or have bloody or black stools. These are signs of stomach bleeding. • pain gets worse or lasts more than 10 days • fever gets worse or lasts more than 3 days • stomach pain or upset gets worse or lasts • redness or swelling is present in the painful area • any new symptoms appear

Indications and Usage

Uses:

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

Dosage and Administration

Directions:

Adults and children 12 years of age and older:

• do not take more than directed • the smallest effective dose should be used • 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 of age: do not use for children under 12 years of age unless directed by a doctor.

Description

ACTIVE INGREDIENT IN EACH TABLET- Ibuprofen 200 mg (NSAID)

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 51727-6

Inactive Ingredients: colloidal silicon dioxide, croscarmellose sodium, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelantinized starch, talc, titanium dioxide.

Section 51945-4

Section 53414-9

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.

Section 55105-1

pain reliever/fever reducer

Section 55106-9

ACTIVE INGREDIENT IN EACH TABLET- Ibuprofen 200 mg (NSAID)


Structured Label Content

Indications and Usage (34067-9)

Uses:

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

Dosage and Administration (34068-7)

Directions:

Adults and children 12 years of age and older:

• do not take more than directed • the smallest effective dose should be used • 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 of age: do not use for children under 12 years of age unless directed by a doctor.

Warnings and Precautions (34071-1)

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 • blisters If an allergic reaction occurs, stop use and seek medical help right away.

Stomach Bleeding Warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause 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 an NSAID [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.

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 use if you have: • problems or serious side effects from taking pain relievers or fever reducers • stomach problems that last or come back, such as heartburn, upset stomach, or stomach pain •

ulcers • bleeding problems • high blood pressure • heart disease, liver cirrhosis, or kidney disease • taken a diuretic • reached age 60 or older

Ask a doctor or pharmacist before use if you are: • taking any other drug containing an NSAID (prescription or nonprescription) • taking a blood thinning (anticoagulant) or steroid drug • 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 • long term continuous use may increase the risk of heart attack or stroke

Stop use and ask a doctor if: • you feel faint, vomit blood, or have bloody or black stools. These are signs of stomach bleeding. • pain gets worse or lasts more than 10 days • fever gets worse or lasts more than 3 days • stomach pain or upset gets worse or lasts • redness or swelling is present in the painful area • any new symptoms appear

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

Inactive Ingredients: colloidal silicon dioxide, croscarmellose sodium, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelantinized starch, talc, titanium dioxide.

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

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.

Section 55105-1 (55105-1)

pain reliever/fever reducer

Section 55106-9 (55106-9)

ACTIVE INGREDIENT IN EACH TABLET- Ibuprofen 200 mg (NSAID)


Advanced Ingredient Data


Raw Label Data

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