Extra Strength Headache Relief

Generic name: acetaminophen, aspirin, and caffeine

Lil' Drug Store Products, Inc.

Dosage Form

N/A

Manufacturer

Lil' Drug Store Products, Inc.

Active ingredients

ACETAMINOPHEN250 mg
ASPIRIN250 mg
CAFFEINE65 mg

Important Safety Information

This medication contains important usage instructions, warnings, and side effect information that you should review before use.

Full label on DailyMed PDF Full label (ZIP)

temporarily relieves minor aches and pains due to:

headache
a cold
arthritis
muscular aches
sinusitis
toothache
premenstrual & menstrual cramps

do not use more than directed (see OVERDOSE WARNING)
drink a full glass of water with each dose
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

What it looks like

Photos of the product and/or packaging supplied by the manufacturer.

Package codes (NDC)

29485-6486-2

Full prescribing information (for healthcare professionals)

Drug Facts

Reye's syndrome

Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

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.

Liver warning

This product contains acetaminophen. Severe liver damage may occur if you take

more than 8 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

Stomach bleeding warning

This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you

are age 60 or older
have had stomach ulcers or bleeding problems
take a blood thinning (anticoagulant) or steroid drug
take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
have 3 or more alcoholic drinks every day while using this product
take more or for a longer time than directed

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.

SPL UNCLASSIFIED SECTION

*This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of EXCEDRIN® EXTRA STRENGTH tablets.

Distributed by: Lil’ Drug Store Products, Inc., Cedar Rapids, IA 52404

Made in India

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Active ingredients

Important Safety Information

What this medicine is forThe uses this medicine is approved for.

How to take itDosage and administration instructions.

Do not use if…Overdose Warning 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…

Ask a doctor before use if…an allergic reaction occurs. Seek medical help right away. you experience any of the following signs of stomach bleeding feel faint vomit blood have bloody or black stools have stomach pain that does not get better ringi…

Ask a doctor or pharmacist before use if…any other drug containing an NSAID (prescription or nonprescription) a prescription drug for diabetes, gout, or arthritis any other drug, or are under a doctor's care for any serious condition a blood thinning (anticoagu…

Stop use and talk to a doctor if…if you have ever had an allergic reaction to acetaminophen, aspirin or any other pain reliever/fever reducer with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a d…

Storage and handlingEach caplet contains: Magnesium 0.58 mg store at controlled room temperature 20º - 25º C (68º - 77º F) read all product information before using. Keep this box for important information

Package labelCOMPARE TO THE ACTIVE INGREDIENTS IN EXCEDRIN® EXTRA STRENGTH Extra Strength Headache Relief Acetaminophen Aspirin (NSAID) and Caffeine Pain Reliever/Fever Reducer 25 POUCHES 2 CAPLETS PER POUCH