Label: ACETAMINOPHEN AND IBUPROFEN tablet
- NDC Code(s): 70000-0622-1, 70000-0622-2
- Packager: LEADER/ Cardinal Health 110, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated January 24, 2024
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients (in each caplet)
- Purposes
- Uses
- Acetaminophen liver damage warning
- Acetaminophen allergy alert
- NSAID allergy alert
-
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
- Do not use
-
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
- When using this product
-
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
- If pregnant or breast-feeding,
- Keep out of reach of children
- Overdose warning
- Directions
- Other information
-
Inactive ingredients
carnauba wax, colloidal silicon dioxide, croscarmellose sodium, crospovidone, ferric oxide red, ferric oxide yellow, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, pregelatinized starch, sodium lauryl sulfate, stearic acid and titanium dioxide.
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- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ACETAMINOPHEN AND IBUPROFEN
acetaminophen and ibuprofen tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70000-0622 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 250 mg IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN 125 mg Inactive Ingredients Ingredient Name Strength POLYDEXTROSE (UNII: VH2XOU12IE) CROSPOVIDONE (UNII: 2S7830E561) HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6) FERRIC OXIDE RED (UNII: 1K09F3G675) POVIDONE K90 (UNII: RDH86HJV5Z) STARCH, CORN (UNII: O8232NY3SJ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) HYPROMELLOSE 2910 (3 MPA.S) (UNII: 0VUT3PMY82) HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) CARNAUBA WAX (UNII: R12CBM0EIZ) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) SODIUM LAURYL SULFATE (UNII: 368GB5141J) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color yellow Score no score Shape OVAL (CAPSULE SHAPED, BICONVEX) Size 14mm Flavor Imprint Code G;131 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70000-0622-1 18 in 1 BOTTLE; Type 0: Not a Combination Product 07/15/2023 2 NDC:70000-0622-2 36 in 1 BOTTLE; Type 0: Not a Combination Product 07/15/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA216592 07/15/2023 Labeler - LEADER/ Cardinal Health 110, Inc. (063997360)