Active Ingredient (In Each Tablet)
Acetaminophen 500 mg
Pain Reliever Tablet
FDA Label NDC 0363-1480
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Walgreen Company for the product Pain Reliever (NDC 0363-1480). 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 ingredient (in each tablet), purpose, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Pain reliever/fever reducer
Uses
- temporarily relieves minor aches and pains due to:
- headache
- backache
- muscular aches
- minor pain of arthritis
- headache
- temporarily reduces fever
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4,000 mg of acetaminophen in 24 hours
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
- skin reddening
- blisters
- rash
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away.
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 are allergic to acetaminophen or any of the inactive ingredients in this product
Ask A Doctor Before Use If You Have
liver disease.
Ask A Doctor Or Pharmacist Before Use If You Are
taking the blood thinning drug warfarin.
Stop Use And Ask A Doctor If
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- new symptoms occur
- redness or swelling is present
These could be signs of a serious condition.
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children.
In case of accidental 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 tablets every 6 hours while symptoms persist or as directed by a doctor
- do not take more than 6 tablets in 24 hours, unless directed by a doctor
- do not take for more than 10 days unless directed by a doctor
- children under 12 years: ask a doctor
Other Information
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- see end flap for expiration date and lot number
Inactive Ingredients
corn starch, povidone, sodium starch glycolate, stearic acid
Questions Or Comments?
1-800-426-9391
Principal Display Panel
Walgreens
Compare to the active ingredient in
Panadol® Extra Strength Tablets††
WALGREENS PHARMACIST RECOMMENDED†
NDC 0363-1480-01
Pain Reliever
ACETAMINOPHEN 500 mg / PAIN RELIEVER / FEVER REDUCER
Extra Strength
30 TABLETS
ACTUAL SIZE
TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
†Our pharmacists recommend the
Walgreens brand. We invite you to
compare to national brands.
††This product is not manufactured or
distributed by GlaxoSmithKline
Consumer Healthcare (UK), owner of
the registered trademark Panadol®
Extra Strength Tablets.
50844 ORG072114801
DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015
100% SATISFACTION GUARANTEED
walgreens.com ©2021 Walgreen co.
Walgreens B-2201-148-01-wdhr Org0721 (Walgreens 44 148 P Pain Reliever 1)
* Please review the disclaimer below.
