Drug Facts
b431a1a3-39c4-4d6c-afdc-c8b017ad89da
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Acetaminophen 500 mg Caffeine 65mg
Purpose
Pain reliever Pain reliever aid
Medication Information
Purpose
Pain reliever
Pain reliever aid
Description
Acetaminophen 500 mg Caffeine 65mg
Uses
temporary relief of 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 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.
Directions
Do not exceed recommended dosage.
Adults and children 12 years and over: take 2 tablets every 6 hours. Do not take more than 8 tablets in 24 hours
Children under 12 years: ask a doctor
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.
Inactive Ingredients
corn starch, croscarmellose sodium, crospovidone, D&C red #27 aluminum lake, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, silicon dioxide, stearic acid, titanium dioxide
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.
Keep Out of Reach of Children.
In case of accidental overdose, get medical help or contact a PoisonControlCenter immediately. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms
Ask Doctor Before Use If You Have
liver disease
Active Ingredient (in Each Caplet)
Acetaminophen 500 mg
Caffeine 65mg
Package/label Principal Display Panel
*Compare to the active ingredients in Excedrin® Tension Headache
See new warnings information
TENSION HEADACHE RELIEF
Acetaminophen and Caffeine
Aspirin Free
Pain Reliever/Pain Reliever Aid
Caplets
Structured Label Content
Uses
temporary relief of minor aches and pains due to ■ headache ■ muscular aches
Purpose
Pain reliever
Pain reliever aid
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.
Directions
Do not exceed recommended dosage.
Adults and children 12 years and over: take 2 tablets every 6 hours. Do not take more than 8 tablets in 24 hours
Children under 12 years: ask a doctor
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.
Inactive Ingredients
corn starch, croscarmellose sodium, crospovidone, D&C red #27 aluminum lake, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, silicon dioxide, stearic acid, titanium dioxide
Stop Use and Ask A Doctor If (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, (If pregnant or breast-feeding,)
ask a health professional before use.
Keep Out of Reach of Children. (Keep out of reach of children.)
In case of accidental overdose, get medical help or contact a PoisonControlCenter immediately. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms
Ask Doctor Before Use If You Have (Ask doctor before use if you have)
liver disease
Active Ingredient (in Each Caplet) (Active ingredient (in each caplet))
Acetaminophen 500 mg
Caffeine 65mg
Package/label Principal Display Panel (Package/Label Principal Display Panel)
*Compare to the active ingredients in Excedrin® Tension Headache
See new warnings information
TENSION HEADACHE RELIEF
Acetaminophen and Caffeine
Aspirin Free
Pain Reliever/Pain Reliever Aid
Caplets
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:02:18.148405 · Updated: 2026-03-14T23:01:45.300207