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Drug Facts
The following Structured Product Label (SPL) was submitted to the FDA by R J General Corporation for the product Acetaminophen 250 Mg And Ibuprofen 125 Mg (NDC 70264-040). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, active ingredients (in each caplet), uses, warnings, do not use, ask a doctor before use if, ask a doctor or pharmacist before use if you are, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Drug Facts
| Active ingredients (in each tablet) | Purpose |
|---|---|
| Acetaminophen 250 mg | Pain reliever |
| Ibuprofen 125 mg (NSAID)
nonsteroidal anti-inflammatory drug | Pain reliever |
Acetaminophen liver damage warning:
This product contains acetaminophen. Severe liver damage may occur if you take:
Acetaminophen allergy alert:may cause severe skin reactions. Symptoms may include:
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:
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:
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.
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 problems in the unborn child or complications during delivery.
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 symptoms.
| adults and children 12 years and over | • take 2 caplets every 8 hourswhile symptoms persist |
| children under 12 years | • ask a doctor |
carnauba wax, colloidal silicon dioxide, croscarmellose sodium, ferric oxides, glyceryl dibehenate, hypromellose, pharmaceutical ink, polydextrose, polyethylene glycol, pregelatinized starch, titanium dioxide
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Packaged and distributed by RJ Corp with the permission of HALEON.
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