Otc - Active Ingredient
Active ingredients (in each caplet)
Acetaminophen 250 mg
Ibuprofen 125 mg (NSAID*)
*nonsteroidal anti-inflammatory drug
The following Structured Product Label (SPL) was submitted to the FDA by Kroger Company for the product Dual Action (NDC 41226-716). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active ingredients (in each caplet)
Acetaminophen 250 mg
Ibuprofen 125 mg (NSAID*)
*nonsteroidal anti-inflammatory drug
Purposes
Pain reliever
Pain reliever
Uses
temporarily relieves minor aches and pains due to:
Warnings
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.
Do not use
Ask a doctor before use if
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:
you have symptoms of heart problems or stroke:
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, 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.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
| adults and children 12 years and over |
|
| children under 12 years |
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Other information
Inactive ingredients colloidal anhydrous silica, corn starch, croscarmellose sodium, glyceryl dibehenate, hypromellose, microcrystalline cellulose, polydextrose, povidone, red iron oxide, titanium dioxide, triacetin, yellow iron oxide.
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* Please review the disclaimer below.