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 Meijer Distribution Inc for the product Acetaminophen And Ibuprofen (NDC 79481-6501). 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, uses, 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
temporarily relieves minor aches and pains due to:
■ headache ■ toothache ■ backache ■ menstrual cramps
■ muscular aches ■ minor pain of arthritis
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 Kenvue Inc., owner of the registered trademarks Motrin® and Tylenol®.
DIST. MEIJER DISTRIBUTION, INC.
GRAND RAPIDS, MI 49544
www.meijer.com
PID 5506555
MADE IN INDIA
Code: TN/Drugs/TN00002222/2006
L0000942
R0125
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, 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
meijer ®
NDC 79481-6501-7
Dual Pain Reliever
COMPARE TO MOTRIN
DUAL ACTION with
Tylenol ®
ACTIVE INGREDIENTS***
ACETAMINOPHEN 250 mg AND IBUPROFEN
(NSAID) 125 mg TABLETS | PAIN RELIEVER
CONTAINS 2 MEDICINES
For Aches & Pains
Acetaminophen + Ibuprofen
DUAL ACTION
80
CAPLETS**
** CAPSULE-SHAPED TABLETS
* Please review the disclaimer below.