ACETAMINOPHEN, IBUPROFEN tablet, film coated
Acetaminophen, Ibuprofen by
Drug Labeling and Warnings
Acetaminophen, Ibuprofen by is a Otc medication manufactured, distributed, or labeled by GLENMARK THERAPEUTICS INC., USA, Glenmark Pharmaceuticals Limited. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
- Active ingredients (in each caplet)
- Purposes
- INDICATIONS & USAGE
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WARNINGS
Warnings
Acetaminophen liver damage warning:
This product contains acetaminophen. Severe liver damage may occur if you take:
- with other drugs containing acetaminophen
- more than 6 caplets in 24 hours, which is the maximum daily amount for this product
- 3 or more alcoholic drinks every day while using this product
Acetaminophen allergy alert: may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash
If skin reaction occurs, stop use and seek medical help right away.
NSAID 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.
NSAID 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
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist
- if you have ever had an allergic reaction to acetaminophen or any other pain reliever
- right before or after heart surgery
Ask a doctor before use if
- you have liver disease
- stomach bleeding warning applies to you
- you have problems or serious side effects from taking pain relievers
- 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 a doctor or pharmacist before use if you are
- under a doctor's care for any serious condition
- taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
- taking any other drug
Stop use and ask a doctor if
-
you experience any of the following signs of stomach bleeding:
- o feel faint
- o vomit blood
- o have bloody or black stools
- o have stomach pain that does not get better
-
you have symptoms of heart problems or stroke:
- o chest pain
- o trouble breathing
- o weakness in one part or side of body
- o slurred speech
- o leg swelling
- pain gets worse or lasts more than 10 days
- redness or swelling is present in the painful area
- any new symptoms appear
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- QUESTIONS
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PRINCIPAL DISPLAY PANEL
NDC: 72657-157-74
Acetaminophen 250 mg and Ibuprofen (NSAID) 125 mg Tablets
Pain Reliever
144’sCaplets*
*Capsule-Shaped Tablets -
INGREDIENTS AND APPEARANCE
ACETAMINOPHEN, IBUPROFEN
acetaminophen, ibuprofen tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 72657-157 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN 125 mg ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 250 mg Inactive Ingredients Ingredient Name Strength STARCH, CORN (UNII: O8232NY3SJ) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) POVIDONE K90 (UNII: RDH86HJV5Z) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) GLYCERYL DIBEHENATE (UNII: R8WTH25YS2) HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POLYDEXTROSE (UNII: VH2XOU12IE) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) SHELLAC (UNII: 46N107B71O) FERROSOFERRIC OXIDE (UNII: XM0M87F357) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) Product Characteristics Color YELLOW (light yellow to yellow) Score no score Shape CAPSULE Size 15mm Flavor Imprint Code G375 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 72657-157-18 1 in 1 CARTON 05/07/2024 1 18 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC: 72657-157-36 1 in 1 CARTON 05/07/2024 2 36 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC: 72657-157-72 1 in 1 CARTON 05/07/2024 3 72 in 1 BOTTLE; Type 0: Not a Combination Product 4 NDC: 72657-157-74 1 in 1 CARTON 05/07/2024 4 144 in 1 BOTTLE; Type 0: Not a Combination Product 5 NDC: 72657-157-76 1 in 1 CARTON 05/07/2024 5 216 in 1 BOTTLE; Type 0: Not a Combination Product 6 NDC: 72657-157-20 1 in 1 CARTON 05/07/2024 6 250 in 1 BOTTLE; Type 0: Not a Combination Product 7 NDC: 72657-157-05 1 in 1 CARTON 05/07/2024 7 500 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA218311 05/07/2024 Labeler - GLENMARK THERAPEUTICS INC., USA (969085666) Establishment Name Address ID/FEI Business Operations Glenmark Pharmaceuticals Limited 862603186 ANALYSIS(72657-157) , MANUFACTURE(72657-157)
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