Otc - Active Ingredient
ACTIVE INGREDIENTS (IN EACH CAPLET)
Acetaminophen 500 mg - Caffeine 65 mg
Tension Headache Relief Tablet, Coated
FDA Label NDC 11673-839
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Target Corporation for the product Tension Headache Relief (NDC 11673-839). 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 otc - active ingredient, inactive ingredient, otc - purpose, indications & usage, dosage & administration, otc - keep out of reach of children, warnings, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredient
colloidal silicon dioxide, pregelatinized starch, D&C red no. 27 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C yellow no. 6 aluminum lake, hypromellose, microcrystalline cellulose, polyethylene glycol (PEG 400), povidone stearic acid,talc, titanium dioxide
Otc - Purpose
Pain reliever - Pain reliever aid
Indications & Usage
USES
• temporarily relieves minor aches and pain due to: • headache - • muscular aches
Dosage & Administration
DIRECTIONS
•
do not use more than directed
•
adults and children 12 years and over: take 2 caplets every 6 hours; not more than 6 caplets in 24 hours
•
children under 12 years: ask a doctor
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
In case of accidental overdose, get medical help or contact a Poison Control Center right away (1-800-222-1221). Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Warnings
WARNINGS
Allergy alert: 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.
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
•
more than 6 caplets in 24 hours, which is the maximum daily amount
•
with other drugs containing acetaminophen
•
3 or more alcoholic drinks every day while using this product
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.
Package Label.Principal Display Panel
100ct (373r)
* Please review the disclaimer below.
