Tension Headache Relief
Tension Headache Relief is an FDA drug label for the active ingredient TENSION HEADACHE RELIEF manufactured by Allegiant Health administered by ORAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20211122.
- Generic name
- TENSION HEADACHE RELIEF
- Manufacturer
- Allegiant Health
- Product type
- HUMAN OTC DRUG
- Route
- ORAL
- Dosage form
- N/A
- NDC
- 69168-001
- Application
- M013
- Label effective
- 20211122
Active ingredients
Indications & Usage
Use(s) temporarily relieves minor aches and pains 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 8 caplets in 24 hours Children under 12 years: ask a doctor
Contraindications
Not available.
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 if you are allergic to acetaminophen with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. 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 any new symptoms occur 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 These could be signs of a serious condition. Pregnancy/Breastfeeding If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children, even if you do not notice any signs or symptoms.
Adverse Reactions
Not available.