FDA Label for Tension Headache Relief
View Indications, Usage & Precautions
Tension Headache Relief Product Label
The following document was submitted to the FDA by the labeler of this product Target Corporation. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
ACTIVE INGREDIENTS (IN EACH CAPLET)
Acetaminophen 500 mg - Caffeine 65 mg
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
* Please review the disclaimer below.