Tension Headache Relief

FDA Drug Profile — Tension Headache Relief

Drug Details

Generic Name
Tension Headache Relief
Brand Names
Tension Headache Relief
Application Number
M013
Sponsor
Allegiant Health
NDC Codes
2
Dosage Forms
CAPSULE, COATED, CAPSULE
Routes
ORAL
Active Ingredients
ACETAMINOPHEN, CAFFEINE

Indications and Usage

Uses temporary relief of minor aches and pains due to ■ headache ■ muscular aches

Warnings

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.