Label: IBUPROFEN tablet, film coated
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NDC Code(s):
49483-611-00,
49483-611-01,
49483-611-05,
49483-612-00, view more49483-612-01, 49483-612-05
- Packager: TIME CAP LABORATORIES,INC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated November 16, 2016
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INACTIVE INGREDIENT
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DOSAGE & ADMINISTRATION
do not take more than directedthe smallest effective dose should be used
do not take longer than 10 days, unless directed by a docter
(see Wanings)adults and children 12 years and olderChildren under 12 years
take 1 tablet every 4 to 6 hours while symptoms persistif 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.
ask a doctor
- INDICATIONS & USAGE
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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 reddeningIf 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; take more or for a longer time than directed - IBUPROFEN TABLETS, USP ORANGE CAPSULE-SHAPED LABEL
- IBUPROFEN TABLETS USP 200 MG ROUND ORANGE
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INGREDIENTS AND APPEARANCE
IBUPROFEN
ibuprofen tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49483-611 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 CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color orange Score no score Shape CAPSULE Size 10mm Flavor Imprint Code 120 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49483-611-00 6500 in 1 BAG; Type 0: Not a Combination Product 11/16/2016 2 NDC:49483-611-05 50 in 1 BOTTLE; Type 0: Not a Combination Product 11/16/2016 3 NDC:49483-611-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 11/16/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA091237 11/16/2016 IBUPROFEN
ibuprofen tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49483-612 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 CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color orange Score no score Shape ROUND Size 15mm Flavor Imprint Code 115 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49483-612-00 6500 in 1 BAG; Type 0: Not a Combination Product 11/16/2016 2 NDC:49483-612-05 50 in 1 BOTTLE; Type 0: Not a Combination Product 11/16/2016 3 NDC:49483-612-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 11/16/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA091237 11/16/2016 Labeler - TIME CAP LABORATORIES,INC (037052099) Establishment Name Address ID/FEI Business Operations MARKSANS PHARMA LIMITED 925822975 manufacture(49483-611, 49483-612)