Tension Headache Relief
- Dosage form
- TABLET, FILM COATED
- Labeler
- Spirit Pharmaceuticals LLC
- Label updated
- 2024-12-30
- Retrieved
- 2026-09-07
- Active ingredients
- ACETAMINOPHEN · CAFFEINE
Drug Facts
Active Ingredient (in each tablet)
Acetaminophen 500 mg
Caffeine 65 mg
Purpose
Pain reliever
Pain reliever aid
Uses
Temporarily relieves 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 6 tablets 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
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.
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.
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 (1-800-222-1222).
Directions
• do not use more than directed • adults and children 12 years and over; take 2 tablets every 6 hours; not more than 6 tablets in 24 hours • children under 12 years: ask a doctor
Other Information
• Store at 20°–25°C (68°–77°F) • close cap tightly after use • read all product information before using
Inactive ingredients
Colloidal silicon dioxide, croscarmellose sodium, D&C Red No. 27, FD&C Blue No. 2, FD&C Yellow No. 6, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, purified water, stearic acid, talc, titanium dioxide
Questions or comments?
1-888-333-9792
Distributed by:
Cabinet Health P.B.C.
Pouch
[Image in the official label — see DailyMed source]
DailyMed Set ID: 1f6d9723-9e11-4973-af3a-66a6a7ad5cc3 · Version 5
NDC: 68210-4184