- DRUG FACTS
- ACTIVE INGREDIENT
- PURPOSE
- USES
-
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 perscription or nonperscription 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
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 or asthma
- 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
- the risk of heart attack or stroke may increase if you use more than directed or for longer than directed
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
- 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
-
DIRECTIONS
- do not take more than directed
- the smallest effective dose should be used
- do not take longer than 10 days, unless directed by a doctor (see WARNINGS )
- 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
- INACTIVE INGREDIENTS
-
PRODUCT PACKAGING
The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.
DG
health
Compare to active ingredient of Motrin® IB†
Ibuprofen
Tablets 200 mg
Pain Reliever/Fever Refucer (NSAID)
SEE NEW WARNINGS INFORMATION
100
Coated Tablets
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
DISTRIBUTED BY DOLGENCORP, LLC
GOODLETTSVILLE, TN 37072
-
INGREDIENTS AND APPEARANCE
IBUPROFEN
ibuprofen tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55910-392 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Ibuprofen (UNII: WK2XYI10QM) (Ibuprofen - UNII:WK2XYI10QM) Ibuprofen 200 mg Inactive Ingredients Ingredient Name Strength Carnauba Wax (UNII: R12CBM0EIZ) Powdered Cellulose (UNII: SMD1X3XO9M) Starch, Corn (UNII: O8232NY3SJ) Fd&c Yellow No. 6 (UNII: H77VEI93A8) Hypromellose (UNII: 3NXW29V3WO) Lactose (UNII: J2B2A4N98G) Magnesium Stearate (UNII: 70097M6I30) Polydextrose (UNII: VH2XOU12IE) Polyethylene Glycol (UNII: 3WJQ0SDW1A) Stearic Acid (UNII: 4ELV7Z65AP) Titanium Dioxide (UNII: 15FIX9V2JP) Product Characteristics Color ORANGE Score no score Shape ROUND Size 10mm Flavor Imprint Code 44;392 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55910-392-12 1 in 1 CARTON 1 100 in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075139 03/02/1999 Labeler - DOLGENCORP, LLC (068331990) Registrant - L.N.K. International, Inc. (038154464) Establishment Name Address ID/FEI Business Operations L.N.K. International, Inc. 038154464 MANUFACTURE