SEE NEW WARNINGS Ibuprofen Tablets USP, 200 mg Pain Reliever/Fever Reducer (NSAID)**

SEE NEW WARNINGS Ibuprofen Tablets USP, 200 mg Pain Reliever/Fever Reducer (NSAID)**

Drug Labeling and Warnings

Drug Details

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IBUPROFEN- ibuprofen tablet 
FAMILY DOLLAR

----------

SEE NEW WARNINGS
Ibuprofen
Tablets USP, 200 mg
Pain Reliever/Fever Reducer (NSAID)**

Active ingredient (For Tablet)

(in each tablet)

Ibuprofen 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Active ingredient (For Caplet)

(in each caplet)

Ibuprofen 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Uses

■ 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

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 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 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 during the last 3 months of 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 the reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions (For Tablets)

■ 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

Directions (For Caplets)

■ do not take more than directed

■ the smallest effective dose should be used

Adults and children 12 years and older

■ 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

Other information

■ store between 20-25°C (68-77°F). [See USP Controlled Temperature]

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

Inactive ingredients

colloidal silicon dioxide, ferric oxide red, maize starch, polyethylene glycol, povidone k-30, pregelatinized starch, sodium starch glycolate, stearic acid, talc, titanium dioxide.

Questions or comments?

call 1-877-770-3183 weekdays 9:00 AM to 4:30PM EST.

Tablets

100 count50 count

Caplets

50 count100 count250 count

IBUPROFEN 
ibuprofen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 55319-396
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
TALC (UNII: 7SEV7J4R1U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
POVIDONE (UNII: FZ989GH94E)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
Product Characteristics
Colorbrown (Reddish Brown color Tablets) Scoreno score
ShapeROUNDSize10mm
FlavorImprint Code G2
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 55319-396-0550 in 1 BOTTLE; Type 0: Not a Combination Product10/29/2018
2NDC: 55319-396-10100 in 1 BOTTLE; Type 0: Not a Combination Product10/29/2018
3NDC: 55319-396-25250 in 1 BOTTLE; Type 0: Not a Combination Product10/29/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07917410/29/2018
IBUPROFEN 
ibuprofen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 55319-397
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
POVIDONE (UNII: FZ989GH94E)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
STARCH, CORN (UNII: O8232NY3SJ)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
Product Characteristics
Colorbrown (Reddish Brown tablets) Scoreno score
ShapeOVAL (Caplet shaped Tablets) Size14mm
FlavorImprint Code G2
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 55319-397-0550 in 1 BOTTLE; Type 0: Not a Combination Product10/29/2018
2NDC: 55319-397-10100 in 1 BOTTLE; Type 0: Not a Combination Product10/29/2018
3NDC: 55319-397-25250 in 1 BOTTLE; Type 0: Not a Combination Product10/29/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07917410/29/2018
Labeler - FAMILY DOLLAR (024472631)

Revised: 12/2018
 
FAMILY DOLLAR


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