ACETAMINOPHEN AND IBUPROFEN tablet
Acetaminophen and Ibuprofen by
Drug Labeling and Warnings
Acetaminophen and Ibuprofen by is a Otc medication manufactured, distributed, or labeled by Granules Pharmaceuticals Inc.. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
- Active ingredients (in each caplet)
- Purposes
- Uses
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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 surgeryAsk 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 diureticAsk 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 drugStop 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 - Directions
- Other information
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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.
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ACETAMINOPHEN AND IBUPROFEN
acetaminophen and ibuprofen tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 70010-131 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 HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6) HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYDEXTROSE (UNII: VH2XOU12IE) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) POVIDONE K30 (UNII: U725QWY32X) POVIDONE K90 (UNII: RDH86HJV5Z) CARNAUBA WAX (UNII: R12CBM0EIZ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) CROSPOVIDONE (UNII: 68401960MK) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) HYPROMELLOSE 2910 (3 MPA.S) (UNII: 0VUT3PMY82) STARCH, CORN (UNII: O8232NY3SJ) SODIUM LAURYL SULFATE (UNII: 368GB5141J) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color yellow (Light yellow to yellow colored) Score no score Shape CAPSULE (capsule shaped, biconvex) Size 14mm Flavor Imprint Code G;131 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 70010-131-26 1 in 1 CARTON 07/24/2023 1 18 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC: 70010-131-31 288 in 1 BOTTLE; Type 0: Not a Combination Product 07/24/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA216592 07/24/2023 Labeler - Granules Pharmaceuticals Inc. (079825711) Establishment Name Address ID/FEI Business Operations Granules Pharmaceuticals Inc. 079825711 analysis(70010-131) , manufacture(70010-131)
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