Active Ingredients (In Each Gelcap)
Acetaminophen 500 mg
(formulated with 65 mg caffeine)
Tension Headache Relief Tablet, Coated
FDA Label NDC 0363-0572
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 Tension Headache Relief (NDC 0363-0572). 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 gelcap), 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
Uses
- temporarily relieves minor aches and pains due to:
- headache
- muscular aches
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.
Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heart beat.
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
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
- new symptoms occur
- painful area is red or swollen
- pain gets worse or lasts for more than 10 days
- fever gets worse or lasts for more than 3 days
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 gelcaps every 6 hours. Do not take more than 6 gelcaps in 24 hours.
- children under 12 years: ask a doctor
Other Information
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- avoid high humidity
- see end flap for expiration date and lot number
Inactive Ingredients
corn starch, FD&C blue #1, FD&C red #40, gelatin, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, propylene glycol, shellac glaze, silicon dioxide, simethicone, sodium starch glycolate, stearic acid, titanium dioxide
Questions Or Comments?
1-800-426-9391
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Compare to Excedrin® Tension
Headache active ingredients††
NDC 0363-0572-31
Tension Headache Relief
ACETAMINOPHEN /
CAFFEINE / PAIN RELIEVER
ASPIRIN FREE GELCAPS
80 GELCAPS
QUICK GELS™
ACTUAL SIZE
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
†Walgreens Pharmacist Survey
††This product is not manufactured or distributed by GSK Consumer Healthcare S.A., owner of the registered trademark Excedrin® Tension Headache.
DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015
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