Active Ingredients (In Each Caplet)
Acetaminophen 500 mg
(formulated with 65 mg caffeine)
Tension Headache Tablet, Film Coated
FDA Label NDC 70000-0159
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cardinal Health 110, Llc. Dba Leader for the product Tension Headache (NDC 70000-0159). 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), 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. The maximum daily dose of this product is 6 caplets (3,000m mg) in 24 hours. 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
- blisters
- rash
- skin reddening
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 heartbeat.
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
- pain gets worse or lasts for more than 10 days
- new symptoms occur
- fever gets worse or lasts for more than 3 days
- painful area is red or swollen
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 (1-800-222-1222) 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 use more than directed
- adults and children 12 years and over: take 2 caplets every 6 hours. Do not take more than 6 caplets 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)
- see end flap for expiration date and lot number
Inactive Ingredients
corn starch, crospovidone, D&C red #27 aluminum lake, FD&C blue #2 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, sodium starch glycolate, stearic acid, talc, titanium dioxide
Questions Or Comments?
1-800-426-9391
Principal Display Panel
NDC 70000-0159-1
Tension Headache
Acetaminophen, 500 mg | Caffeine, 65 mg
Pain reliever
Aspirin Free
100 CAPLETS
ACTUAL SIZE
COMPARE TO EXCEDRIN®
TENSION HEADACHE
active ingredients*
100% Money Back Guarantee
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
*This product is not manufactured or distributed by GSK group of companies, owner of the registered trademark Excedrin® Tension Headache.
50844 REV0417A42812
CardinalHealth™
DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017
www.myleader.com 1-800-200-6313
Essential to Care™ since 1979
@ 2017 Cardinal Health, All Rights Reserved.
CARDINAL HEALTH, the Cardinal Health LOGO,
LEADER, and the Leader LOGO are trademarks
or registered trademarks of Cardinal Health.
100% Money Back Guarantee
Return to place of purchase.
Leader 44-428 (Leader 44 428 1)
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