Label: ACETAMINOPHEN AND IBUPROFEN tablet
- NDC Code(s): 0363-9131-16, 0363-9131-44
- Packager: WALGREENS
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated December 16, 2024
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Active Ingredients (in each caplet)
Acetaminophen 250mg - Ibuprofen 125mg (NSAID)
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Purposes
Pain Reliever - Pain reliever
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Uses
■ temporarily relieves minor aches and pains due to: ■ headache ■ toothache ■ backache - ■ menstrual cramps ■ muscular aches ■ minor pain of arthritis
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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 ...
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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.
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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 ...
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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 ...
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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.
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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 ...
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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 ...
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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
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When using this product
■ Take with food or milk if stomach upset occurs
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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 ...
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If pregnant or breast-feeding
ask a health professional before use. It is especially important not to use ibuprofen at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause ...
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Keep out of reach of children
In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or ...
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Directions
■ do not take more than directed - adults and children 12 years and over - ■ take 2 caplets every 8 hours while symptoms persist - children under 12 years - ■ ask a doctor - ■ do not take more than 6 ...
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Other information
■ read all warnings and directions before use. Keep carton. ■ store at 20 to 25°C (68 to 77°F) ■ avoid excessive heat above 40°C (104°F)
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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 ...
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Questions or comments?
call - 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST
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INGREDIENTS AND APPEARANCEProduct Information