Label: IBUPROFEN tablet, coated
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NDC Code(s):
41226-601-01,
41226-601-05,
41226-601-20,
41226-601-25, view more41226-601-42
- Packager: Kroger Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated January 3, 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:
•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 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
•you have problems or serious side effects from taking pain relievers or fever reducers
•stomach bleeding warning applies to you
•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 doctorchildren under 12 years:
•ask a doctor - OTHER INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
IBUPROFEN
ibuprofen tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41226-601 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 SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FERRIC OXIDE RED (UNII: 1K09F3G675) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) MAGNESIUM STEARATE (UNII: 70097M6I30) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color brown Score no score Shape ROUND (biconvex film coated tablets) Size 10mm Flavor Imprint Code TCL;114 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41226-601-42 1 in 1 CARTON 04/10/2021 1 24 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:41226-601-05 1 in 1 CARTON 06/12/2021 2 50 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:41226-601-01 1 in 1 CARTON 06/12/2021 3 100 in 1 BOTTLE; Type 0: Not a Combination Product 4 NDC:41226-601-20 200 in 1 BOTTLE; Type 0: Not a Combination Product 06/12/2021 5 NDC:41226-601-25 250 in 1 BOTTLE; Type 0: Not a Combination Product 06/12/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 04/10/2021 Labeler - Kroger Company (006999528) Registrant - Time Cap Laboratories, Inc. (037052099) Establishment Name Address ID/FEI Business Operations MARKSANS PHARMA LIMITED 925822975 manufacture(41226-601)