Label: IBUPROFEN tablet, film coated
IBUPROFEN tablet, film coated
IBUPROFEN- ibupfrofen tablet, film coated
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NDC Code(s):
49483-114-10,
49483-114-17,
49483-114-50,
49483-114-73, view more49483-600-01, 49483-600-05, 49483-600-50, 49483-601-00, 49483-601-01, 49483-601-05, 49483-601-10, 49483-601-50
- Packager: TIME CAP LABORATORIES,INC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated November 22, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- DRUG FACTS
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
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 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
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ASK DOCTOR
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, asthma, or had a stroke
• you are taking a diuretic
- ASK DOCTOR/PHARMACIST
- WHEN USING
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STOP USE
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 problem or stroke:
- chest pain
- trouble breathing
- weakness in one part or side of the 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
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
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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 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 INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
IBUPROFEN
ibuprofen tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49483-114 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 TITANIUM DIOXIDE (UNII: 15FIX9V2JP) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) TALC (UNII: 7SEV7J4R1U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) FERRIC OXIDE RED (UNII: 1K09F3G675) STARCH, CORN (UNII: O8232NY3SJ) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) Product Characteristics Color brown Score no score Shape ROUND (Biconvex) Size 10mm Flavor Imprint Code 114 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49483-114-50 500 in 1 BOTTLE; Type 0: Not a Combination Product 09/09/2021 2 NDC:49483-114-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 09/09/2021 3 NDC:49483-114-17 200 in 1 BOTTLE; Type 0: Not a Combination Product 08/19/2023 4 NDC:49483-114-73 100 in 1 BOTTLE; Type 0: Not a Combination Product 11/18/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA091239 03/22/2016 IBUPROFEN
ibuprofen tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49483-601 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 MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYVINYL ALCOHOL (UNII: 532B59J990) STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FERRIC OXIDE RED (UNII: 1K09F3G675) Product Characteristics Color brown Score 2 pieces Shape ROUND Size 10mm Flavor Imprint Code 114 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49483-601-00 6500 in 1 BAG; Type 0: Not a Combination Product 03/22/2016 2 NDC:49483-601-05 50 in 1 BOTTLE; Type 0: Not a Combination Product 03/22/2016 3 NDC:49483-601-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 03/22/2016 4 NDC:49483-601-50 500 in 1 BOTTLE; Type 0: Not a Combination Product 03/22/2016 08/07/2021 5 NDC:49483-601-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 03/22/2016 08/07/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA091239 03/22/2016 IBUPROFEN
ibupfrofen tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49483-600 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 SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FERRIC OXIDE RED (UNII: 1K09F3G675) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POLYVINYL ALCOHOL (UNII: 532B59J990) STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ) TALC (UNII: 7SEV7J4R1U) Product Characteristics Color brown Score 2 pieces Shape CAPSULE Size 15mm Flavor Imprint Code 117 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49483-600-05 50 in 1 BOTTLE; Type 0: Not a Combination Product 03/22/2016 2 NDC:49483-600-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 03/22/2016 3 NDC:49483-600-50 500 in 1 BOTTLE; Type 0: Not a Combination Product 11/14/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA091239 03/22/2016 Labeler - TIME CAP LABORATORIES,INC (037052099) Registrant - TIME CAP LABORATORIES,INC (037052099) Establishment Name Address ID/FEI Business Operations MARKSANS PHARMA LIMITED 925822975 manufacture(49483-601, 49483-600, 49483-114)