Active Ingredients (In Each Caplet)
Acetaminophen, USP 250 mg
Ibuprofen, USP 125 mg (NSAID*)
*nonsteroidal anti-inflammatory drug
The following Structured Product Label (SPL) was submitted to the FDA by Chain Drug Marketing Association Inc. for the product Dual Action Pain Reliever (NDC 83324-178). 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 active ingredients (in each caplet), purposes, indications & usage, warnings, acetaminophen liver damage warning:, other, nsaid stomach bleeding warning:, heart attack and stroke warning:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Acetaminophen, USP 250 mg
Ibuprofen, USP 125 mg (NSAID*)
*nonsteroidal anti-inflammatory drug
Pain reliever
Pain reliever
Uses
Warnings
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.
Do not use with other medicines containing ACETAMINOPHEN; can cause liver damage.
DO NOT USE IF TAMPER-EVIDENT SEAL UNDER BOTTLE CAP IMPRINTED WITH “ SEALED for YOUR PROTECTION” IS BROKEN OR MISSING.
***This product is not manufactured or distributed by the owners of Advil® Dual Action with Acetaminophen.
MADE IN INDIA
949129306
Code: TN/Drugs/TN00002222/2006
Distributed by CDMA, Inc.
Novi, MI 48375
www.qualitychoice.com
Questions: 800-935-2362
L0000881
R0724
Lot No.:
Exp. Date:
This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:
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.
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. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
■ do not take more than directed
| adults and children 12 years and over | ■ take 2 caplets every 8 hourswhile symptoms persist |
| children under 12 years | ■ ask a doctor |
■ do not take more than 6 caplets in 24 hours, unless directed by a doctor
Other information
Inactive ingredients
carnauba wax, colloidal silicon dioxide, croscarmellose sodium, crospovidone, ferric oxide red, ferric oxide yellow, glyceryl dibehenate, hypromellose, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, pregelatinized starch, sodium lauryl sulphate, stearic acid, titanium dioxide
Questions or comments?
call toll-free 1-888-235-2466
NDC 83324-178-44
QUALITY CHOICE
***Compare to the Active Ingredients in
Advil® Dual Action with Acetaminophen
Dual Action Pain Reliever
Acetaminophen and Ibuprofen (NSAID) Tablets, 250 mg/125 mg
Contains 2 Medicines
Acetaminophen + Ibuprofen
144 Caplets** **Capsule-shaped tablets
Actual Size
* Please review the disclaimer below.