- ACTIVE INGREDIENT(S)
- PURPOSE
- USE(S)
-
WARNINGS
Allergy alerts: Ibuprofen may cause a severe allergy reaction, especially in people allergic to aspirin.
Symptoms may include:
- asthma (wheezing)
- blisters
- facial swelling
- hives
- rash
- shock
- skin reddening
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 bad stomach ulcers or bleeding problems
- take a blood thinning (anticoagulant) or steroid drug
- take other drug containing prescription NSAID (aspirin, ibuprofen, naproxen, or others)
- have 3 or more alcoholic drinks every day while using this product
- the more or for a longer time than directed
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF
-
ASK A DOCTOR OR PHARMACIST BEFORE USE IF
you are
- taking any other drugs containg an NSAID (prescription or nonprescription)
- taking a blood thining (anticoagulant) or steriod drug
- under a doctor’s care for any serious condition
- taking aspirin for heart attacks or stroke, because ibuprofen may decrease this benefit of aspirin
- taking any other drug
- WHEN USING THIS PRODUCT
- STOP USE AND ASK DOCTOR IF
- PREGNANCY/BREASTFEEDING
- KEEP OUT OF REACH OF CHILDREN
-
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 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
- STORAGE
- INACTIVE INGREDIENTS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
IBUPROFEN
ibuprofen tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11383-151 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 COLLOIDAL SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) MAGNESIUM STEARATE (UNII: 70097M6I30) FERRIC OXIDE RED (UNII: 1K09F3G675) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) STARCH, CORN (UNII: O8232NY3SJ) POLYVINYL ALCOHOL (UNII: 532B59J990) Product Characteristics Color BROWN Score no score Shape CAPSULE Size 15mm Flavor Imprint Code 117 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11383-151-50 1 in 1 CARTON 1 50 in 1 BOTTLE 2 NDC:11383-151-11 1 in 1 CARTON 2 100 in 1 BOTTLE 3 NDC:11383-151-21 1 in 1 CARTON 3 200 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA091239 05/17/2013 Labeler - Weeks & Leo Co., Inc. (005290028) Registrant - Weeks & Leo Co., Inc. (005290028) Establishment Name Address ID/FEI Business Operations Marksans Pharma Limited 925822975 MANUFACTURE(11383-151)