Good

Good
SPL v2
SPL
SPL Set ID 24fb3741-65e0-898d-e063-6394a90af569
Route
ORAL
Published
Effective Date 2024-11-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ibuprofen (200 mg)
Inactive Ingredients
Silicon Dioxide Ferric Oxide Red Polyethylene Glycol, Unspecified Starch, Corn Polyvinyl Alcohol, Unspecified Povidone K30 Water Sodium Starch Glycolate Type A Stearic Acid Talc Titanium Dioxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-10-28

Description

Ibuprofen 200 mg (NSAID)* *nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/Fever reducer


Medication Information

Purpose

Pain reliever/Fever reducer

Description

Ibuprofen 200 mg (NSAID)* *nonsteroidal anti-inflammatory drug

Uses

■ temporarily relieves minor aches and pains due to:

      ■ headache ■ toothache ■ backache ■ menstrual cramps

      ■ the common cold ■ muscular aches ■ minor pain of arthritis

■ temporarily reduces fever

Section 42229-5

Compare to the active ingredient of Advil® Ibuprofen Tablets*

Pain Reliever/ Fever Reducer (NSAID)

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Distributed by:                                                                                                                                                                    

Strive Pharmaceuticals Inc.,

East Brunswick, NJ 08816

PRODUCT OF INDIA

*This product is not manufactured or distributed by Pfizer Consumer Healthcare, owner of the registered trade mark Advil® Tablets.

READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION

Section 50565-1

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

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. 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 problems or serious side effects from taking pain relievers or fever reducers

■ 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

■ 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 ■ 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 problems in the unborn child or complications during delivery.

Packaging

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

Other Information

■ store at room temperature between 20 - 25°C (68-77°F)                                                                                                             

■ avoid excessive heat above 40°C (104°F)

Inactive Ingredients

colloidal silicon dioxide, iron oxide red, macrogol/peg, maize starch, polyvinyl alcohol, povidone K-30, pregelatinized starch,

purified water, sodium starch glycolate, stearic acid, talc, titanium dioxide

Questions Or Comments?

1-888-577-8033 Monday - Friday 8am - 4pm EST

Active Ingredient (in Each Tablet)

Ibuprofen 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug


Structured Label Content

Uses

■ temporarily relieves minor aches and pains due to:

      ■ headache ■ toothache ■ backache ■ menstrual cramps

      ■ the common cold ■ muscular aches ■ minor pain of arthritis

■ temporarily reduces fever

Section 42229-5 (42229-5)

Compare to the active ingredient of Advil® Ibuprofen Tablets*

Pain Reliever/ Fever Reducer (NSAID)

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Distributed by:                                                                                                                                                                    

Strive Pharmaceuticals Inc.,

East Brunswick, NJ 08816

PRODUCT OF INDIA

*This product is not manufactured or distributed by Pfizer Consumer Healthcare, owner of the registered trade mark Advil® Tablets.

READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION

Section 50565-1 (50565-1)

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

Purpose

Pain reliever/Fever reducer

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. 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 problems or serious side effects from taking pain relievers or fever reducers

■ 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

■ 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 ■ 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 problems in the unborn child or complications during delivery.

Packaging

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

Other Information (Other information)

■ store at room temperature between 20 - 25°C (68-77°F)                                                                                                             

■ avoid excessive heat above 40°C (104°F)

Inactive Ingredients (Inactive ingredients)

colloidal silicon dioxide, iron oxide red, macrogol/peg, maize starch, polyvinyl alcohol, povidone K-30, pregelatinized starch,

purified water, sodium starch glycolate, stearic acid, talc, titanium dioxide

Questions Or Comments? (Questions or comments?)

1-888-577-8033 Monday - Friday 8am - 4pm EST

Active Ingredient (in Each Tablet) (Active Ingredient (in each tablet))

Ibuprofen 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)