FDA Label for Only For Headache

Drug Facts

Active Ingredient (In Each Caplet)

Acetaminophen 500mg

Caffeine 65mg

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 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

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 heart beat. 

Do not use

• if you are allergic to acetaminophen
• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist
• for more than 10 days for pain unless directed by a doctor
• for more than 3 days for fever unless directed by a doctor

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     • 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 Childern

In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions:

• take with a full glass of water
• do not take more than directed
• do not take more than 6 caplets in 24 hours

adults and children 12 years of age and over	take 2 caplets every 6 hours, not more than 6 caplets in 24 hours.
under 12 years of age	ask a doctor

Other Information:

• Store at room temperature between 20-25°C (68-77°F).

Inactive Ingredients:

colloidal silicon dioxide, croscarmellose sodium, D&C red #27 aluminum lake, FD&C yellow #6 aluminum lake, gelatin, magnesium stearate, maize starch, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, purified water, sodium starch glycolate, talc, titanium dioxide.

Questions Or Comments ?

1-833-665-9444.