Label: ACETAMINOPHEN AND IBUPROFEN tablet, film coated
- NDC Code(s): 53943-034-76
- Packager: DISCOUNT DRUG MART, INC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated September 8, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- 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:
- feel faint
- vomit blood
- have bloody or black stools
- have stomach pain that does not get better
- you have symptoms of heart problems or stroke:
- chest pain
- trouble breathing
- weakness in one part or side of body
- slurred speech
- 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
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INACTIVE INGREDIENT
Inactive ingredients
carnauba wax, colloidal silicon dioxide, croscarmellose sodium, crospovidone, ferric oxide red, ferric oxide yellow, glyceryl dibehenate, hypromellose, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, pregelatinized starch, sodium lauryl sulphate, stearic acid, titanium dioxide
- QUESTIONS
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SPL UNCLASSIFIED SECTION
***This product is not manufactured or distributed by the owners of Advil ®Dual Action with Acetaminophen.
Do not use with other medicines containing ACETAMINOPHEN; can cause liver damage.
READ AND KEEP CARTON FOR COMPLETE WARNINGS AND INFORMATION
SATISFACTION GARUNTEED
IF DISSATISFIED, RETURN UNUSED PORTION AND PACKAGE TO STORE WHERE PURCHASED. IF UNABLE TO RETUN TO STORE, SEND REASON FOR DISSATISFACTION, NAME, ADDRESS AND EMPTY PACKAGE TO: DISCOUNT DRUG MART, 211 COMMERCE DRIVE, MEDINA, OHIO 44256
DO NOT USE IF TAMPER-EVIDENT SEAL UNDER BOTTLE CAP IMPRINTED WITH “ SEALED for YOUR PROTECTION” IS BROKEN OR MISSING.
Distributed by:
Discount Drug Mart
211 Commerce Drive, Medina, Ohio 44256
www.discount-drugmart.com
MADE IN INDIA
R1222
L0000670
Lot No.:
Exp. Date:
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PRINCIPAL DISPLAY PANEL
CONTAINS 2 MEDICINES
Acetaminophen
+ Ibuprofen
NDC 53943-034-76
DISCOUNT
drug
mart
FOOD FAIR
Acetaminophen and Ibuprofen (NSAID)
Tablets, 250 mg/125 mg
DUAL ACTION PAIN RELIEVER
Compare to the active ingredient in Advil® Dual Action with Acetaminophen
72 Caplets**
**capsule-shaped tablets
Carton
Peel Back Label
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INGREDIENTS AND APPEARANCE
ACETAMINOPHEN AND IBUPROFEN
acetaminophen and ibuprofen tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53943-034 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 CARNAUBA WAX (UNII: R12CBM0EIZ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSPOVIDONE (UNII: 2S7830E561) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) GLYCERYL DIBEHENATE (UNII: R8WTH25YS2) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POVIDONE (UNII: FZ989GH94E) POLYDEXTROSE (UNII: VH2XOU12IE) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) STARCH, CORN (UNII: O8232NY3SJ) SODIUM LAURYL SULFATE (UNII: 368GB5141J) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color yellow Score no score Shape CAPSULE Size 15mm Flavor Imprint Code AI Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53943-034-76 72 in 1 CARTON; Type 0: Not a Combination Product 09/08/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA216999 09/08/2023 Labeler - DISCOUNT DRUG MART, INC. (047741335)