Active Ingredient (In Each Caplet)
Acetaminophen 500 mg
Caffeine 65mg
Tension Headache Relief Capsule
FDA Label NDC 69168-029
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Allegiant Health for the product Tension Headache Relief (NDC 69168-029). 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 caplet), purpose, uses, warnings, do not use, ask doctor before use if you have, stop use and ask a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Pain reliever
Pain reliever aid
Uses
temporary relief of 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 8 tablets in 24 hours, which is the maximum daily amount ■ take with other drugs containing acetaminophen ■ have 3 or more alcoholic drinks every day while using this product
Allergy alert: Aspirin may cause a severe allergic reaction which may include: ■ hives ■ facial swelling ■ asthma (wheezing) ■ shock
Acetaminophen may cause severe skin reactions. Symptoms may include: ■ skin reddening ■ blisters ■ rash
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). Ask a doctor or pharmacist before using with other drugs if you are not sure.
Ask Doctor Before Use If You Have
liver disease
Stop Use And Ask A Doctor If
■ any new symptoms occur ■ symptoms do not get better or worsen ■ 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
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 PoisonControlCenter immediately. 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 exceed recommended dosage.
Adults and children 12 years and over: take 2 tablets every 6 hours. Do not take more than 8 tablets in 24 hours
Children under 12 years: ask a doctor
Inactive Ingredients
colloidal silicon dioxide, corn starch, croscarmellose sodium, crospovidone, D&C Red #27, FD&C Red #40, FD&C Yellow #6, hypromellose, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, stearic acid, titanium dioxide.
Package/Label Principal Display Panel
Health A2Z®
*Compare to the active ingredients in Excedrin® Tension Headache
See new warnings information
TENSION HEADACHE RELIEF
Acetaminophen and Caffeine
Aspirin Free
Pain Reliever/Pain Reliever Aid
Caplets
Tension Headache Relief 24ct. Caplets (029 Health A2z Tension Headache Relief 1)
* Please review the disclaimer below.
