Drug Facts

Drug Facts

SPL v7

SPL

SPL Set ID 12c074d1-81ac-47d2-8747-b018cda0058a

Route

ORAL

Published

Effective Date 2023-12-19

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Acetaminophen (500 mg) Caffeine (65 mg)

Inactive Ingredients

Benzoic Acid D&c Red No. 27 Aluminum Lake Fd&c Blue No. 2 Fd&c Yellow No. 6 Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Polyvinyl Alcohol, Unspecified Povidone, Unspecified Starch, Corn Stearic Acid Titanium Dioxide Talc

Identifiers & Packaging

Pill Appearance

Imprint: ETH Shape: oval Color: red Size: 17 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2016-12-15

Description

Acetaminophen 500 mg Caffeine 65 mg

Purpose

Pain reliever Pain reliever aid

Medication Information

Purpose

Pain reliever Pain reliever aid

Description

Acetaminophen 500 mg Caffeine 65 mg

Uses

•
temporarily relieves minor aches and pain due to:
•
headache
•
muscular aches

Purposes

Pain reliever

Pain reliever aid

Directions

•
do not use more than directed
•
adults and children 12 years and over: take 2 caplets every 6 hours; not more than 6 caplets in 24 hours
•
children under 12 years: ask a doctor

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.

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

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.

Other Information

•
store at 20°-25°C (68°-77°F)
•
close cap tightly after use
•
read all product information before using. Keep this box for important information.

Inactive Ingredients

benzoic acid, D&C red no. 27 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C yellow no. 6 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, stearic acid, talc, titanium dioxide

Questions Or Comments?

1-800-468-7746

Principal Display Panel

EXCEDRIN

TENSION HEADACHE

ASPIRIN-FREE

Acetaminophen 500 mg, Caffeine 65 mg

Pain Reliever / Pain Reliever Aid

ACTUAL SIZE

24 CAPLETS

TAMPER-EVIDENT BOTTLE

DO NOT USE IF INNER SAFETY SEAL UNDER CAP IMPRINTED WITH “SEALED for YOUR PROTECTION” IS BROKEN OR MISSING

Distributed by: Haleon, Warren, NJ 07059

Ask A Doctor Before Use If

•
you have liver disease

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.

Active Ingredients (in Each Caplet)

Acetaminophen 500 mg

Caffeine 65 mg

Ask A Doctor Or Pharmacist Before Use If You Are

•
taking the blood thinning drug warfarin

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.

Structured Label Content

Uses

•
temporarily relieves minor aches and pain due to:
•
headache
•
muscular aches

Purposes

Pain reliever

Pain reliever aid

Directions

•
do not use more than directed
•
adults and children 12 years and over: take 2 caplets every 6 hours; not more than 6 caplets in 24 hours
•
children under 12 years: ask a doctor

Do Not Use (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.

Liver Warning: (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

Caffeine Warning: (Caffeine warning:)

Other Information (Other information)

•
store at 20°-25°C (68°-77°F)
•
close cap tightly after use
•
read all product information before using. Keep this box for important information.

Inactive Ingredients (Inactive ingredients)

Questions Or Comments? (Questions or comments?)

1-800-468-7746

Principal Display Panel

EXCEDRIN

TENSION HEADACHE

ASPIRIN-FREE

Acetaminophen 500 mg, Caffeine 65 mg

Pain Reliever / Pain Reliever Aid

ACTUAL SIZE

24 CAPLETS

TAMPER-EVIDENT BOTTLE

DO NOT USE IF INNER SAFETY SEAL UNDER CAP IMPRINTED WITH “SEALED for YOUR PROTECTION” IS BROKEN OR MISSING

Distributed by: Haleon, Warren, NJ 07059

Ask A Doctor Before Use If (Ask a doctor before use if)

•
you have liver disease

Stop Use and Ask A Doctor If (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, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

Active Ingredients (in Each Caplet) (Active ingredients (in each caplet))

Acetaminophen 500 mg

Caffeine 65 mg

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

•
taking the blood thinning drug warfarin

Allergy Alert: Acetaminophen May Cause Severe Skin Reactions. Symptoms May Include: (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.

Advanced Ingredient Data

[{"name": "ACETAMINOPHEN", "unii": "362O9ITL9D", "classCode": "ACTIB", "strengthNumerator": "500", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "CAFFEINE", "unii": "3G6A5W338E", "classCode": "ACTIB", "strengthNumerator": "65", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "BENZOIC ACID", "unii": "8SKN0B0MIM", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "D&C RED NO. 27 ALUMINUM LAKE", "unii": "ZK64F7XSTX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 2", "unii": "L06K8R7DQK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C YELLOW NO. 6", "unii": "H77VEI93A8", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE CELLULOSE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL, UNSPECIFIED", "unii": "3WJQ0SDW1A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYVINYL ALCOHOL, UNSPECIFIED", "unii": "532B59J990", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POVIDONE, UNSPECIFIED", "unii": "FZ989GH94E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STEARIC ACID", "unii": "4ELV7Z65AP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TALC", "unii": "7SEV7J4R1U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "• temporarily relieves minor aches and pain due to: • headache • muscular aches", "Purposes": "Pain reliever Pain reliever aid", "Directions": "• do not use more than directed • adults and children 12 years and over: take 2 caplets every 6 hours; not more than 6 caplets in 24 hours • children under 12 years: ask a doctor", "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.", "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", "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.", "Other information": "• store at 20°-25°C (68°-77°F) • close cap tightly after use • read all product information before using. Keep this box for important information.", "Inactive ingredients": "benzoic acid, D&C red no. 27 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C yellow no. 6 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, stearic acid, talc, titanium dioxide", "Questions or comments?": "1-800-468-7746", "Principal Display Panel": "EXCEDRIN TENSION HEADACHE ASPIRIN-FREE Acetaminophen 500 mg, Caffeine 65 mg Pain Reliever / Pain Reliever Aid ACTUAL SIZE 24 CAPLETS TAMPER-EVIDENT BOTTLE DO NOT USE IF INNER SAFETY SEAL UNDER CAP IMPRINTED WITH “SEALED for YOUR PROTECTION” IS BROKEN OR MISSING Distributed by: Haleon, Warren, NJ 07059 ©2023 Haleon or licensor. Trademarks are owned by or licensed to the Haleon group of companies. 62000000201976", "Ask a doctor before use if": "• you have liver disease", "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.", "Active ingredients (in each caplet)": "Acetaminophen 500 mg Caffeine 65 mg", "Ask a doctor or pharmacist before use if you are": "• taking the blood thinning drug warfarin", "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."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:51.780900 · Updated: 2026-03-14T23:02:37.591705