- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
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DOSAGE & ADMINISTRATION
Directions
do not take more than directed
the smallest effective dose should be used
adults and children 12 years and over: take 1 capsule every 4 to 6 hours while symptoms persist
if pain or fever does not respond to 1 capsule, 2 capsules may be used
do not exceed 6 capsules in 24 hours, unless directed by a doctor
children under 12 years: ask a doctor
- INDICATIONS & USAGE
- PURPOSE
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WARNINGS
Allergy alerts: 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 directedHeart 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.
- KEEP OUT OF REACH OF CHILDREN
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
IBUPROFEN
ibuprofen capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49483-610 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 AMMONIA (UNII: 5138Q19F1X) FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S) GELATIN (UNII: 2G86QN327L) FERROSOFERRIC OXIDE (UNII: XM0M87F357) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) WATER (UNII: 059QF0KO0R) SHELLAC (UNII: 46N107B71O) SORBITAN MONOOLEATE (UNII: 06XEA2VD56) SORBITAN (UNII: 6O92ICV9RU) Product Characteristics Color green Score no score Shape CAPSULE Size 19mm Flavor Imprint Code 133 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49483-610-44 40 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/23/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA079205 12/23/2015 Labeler - TIME CAP LABORATORIES, INC (037052099) Registrant - TIME CAP LABORATORIES, INC (037052099) Establishment Name Address ID/FEI Business Operations MARKSANS PHARMA LIMITED 925822975 manufacture(49483-610)