drug facts

drug facts

SPL v5

SPL

SPL Set ID 2c8df1c7-7864-48df-939c-d9ae22e0f52c

Route

oral

Published

Effective Date 2020-12-04

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

acetaminophen (500 mg) caffeine (65 mg) aspirin (250 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 talc titanium dioxide carnauba wax fd&c blue no. 1 hydroxypropyl cellulose, unspecified hypromellose, unspecified light mineral oil polysorbate 20 propylene glycol dimethicone, unspecified sorbitan monolaurate

Identifiers & Packaging

Pill Appearance

Imprint: E Shape: oval Shape: capsule Color: red Color: white Size: 17 mm Size: 18 mm Score: 1

Marketing Status

otc monograph drug active Since 2018-09-30

Purpose

Pain reliever Pain reliever aid

Description

Acetaminophen 500 mg Caffeine 65 mg

Medication Information

Warnings

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.

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.

Uses

temporarily relieves minor aches and pains due to:
headache
muscular aches

Purpose

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

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

Description

Acetaminophen 500 mg Caffeine 65 mg

Purposes

Pain reliever

Pain reliever aid

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.

Questions Or Comments?

1-800-468-7746

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

Principal Display Panel (excedrin Extra Strength)

NDC 0067-2000-91

EXCEDRIN _®

EXTRA STRENGTH

Acetaminophen, Aspirin (NSAID) and Caffeine

Pain Reliever / Pain Reliever Aid

100 CAPLETS

TAMPER-EVIDENT BOTTLE

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

Distributed by: GSK Consumer Healthcare,Warren, NJ 07059

Visit us at www.excedrin.com

DO NOT TAKE BOTH PRODUCTS AT THE SAME TIME. USE PRODUCTS AS DIRECTED.

46172044

Principal Display Panel (excedrin Tension Headache)

NDC 0067-8139-01

EXCEDRIN _®

TENSION HEADACHE

Acetaminophen and Caffeine

Pain Reliever / Pain Reliever Aid

Aspirin Free

24CAPLETS

TAMPER-EVIDENT BOTTLE

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

Distributed by: GSK Consumer Healthcare,

Warren, NJ 07059

Visit us at www.excedrin.com

46177299

Ask A Doctor Or Pharmacist Before Use If You Are Taking

a prescription drug for diabetes, gout, or arthritis
any other drug, or are under a doctor’s care for any serious condition

Structured Label Content

Warnings

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.

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

Uses

temporarily relieves minor aches and pains due to:
headache
muscular aches

Purpose

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

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)

Purposes

Pain reliever

Pain reliever aid

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.

Questions Or Comments? (Questions or comments?)

1-800-468-7746

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

Principal Display Panel (excedrin Extra Strength) (Principal Display Panel (Excedrin Extra Strength))

NDC 0067-2000-91

EXCEDRIN _®

EXTRA STRENGTH

Acetaminophen, Aspirin (NSAID) and Caffeine

Pain Reliever / Pain Reliever Aid

100 CAPLETS

TAMPER-EVIDENT BOTTLE

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

Distributed by: GSK Consumer Healthcare,Warren, NJ 07059

Visit us at www.excedrin.com

DO NOT TAKE BOTH PRODUCTS AT THE SAME TIME. USE PRODUCTS AS DIRECTED.

46172044

Principal Display Panel (excedrin Tension Headache) (Principal Display Panel (Excedrin Tension Headache))

NDC 0067-8139-01

EXCEDRIN _®

TENSION HEADACHE

Acetaminophen and Caffeine

Pain Reliever / Pain Reliever Aid

Aspirin Free

24CAPLETS

TAMPER-EVIDENT BOTTLE

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

Distributed by: GSK Consumer Healthcare,

Warren, NJ 07059

Visit us at www.excedrin.com

46177299

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

a prescription drug for diabetes, gout, or arthritis
any other drug, or are under a doctor’s care for any serious condition

Advanced Ingredient Data

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"strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TALC", "unii": "7SEV7J4R1U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"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": "CARNAUBA WAX", "unii": "R12CBM0EIZ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROXYPROPYL CELLULOSE, UNSPECIFIED", "unii": "9XZ8H6N6OH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSE, UNSPECIFIED", "unii": "3NXW29V3WO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LIGHT MINERAL OIL", "unii": "N6K5787QVP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE CELLULOSE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYSORBATE 20", "unii": "7T1F30V5YH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POVIDONE, UNSPECIFIED", "unii": "FZ989GH94E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIMETHICONE, UNSPECIFIED", "unii": "92RU3N3Y1O", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITAN MONOLAURATE", "unii": "6W9PS8B71J", "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": "ACETAMINOPHEN", "unii": "362O9ITL9D", "classCode": "ACTIB", "strengthNumerator": "250", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "ASPIRIN", "unii": "R16CO5Y76E", "classCode": "ACTIB", "strengthNumerator": "250", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "CAFFEINE", "unii": "3G6A5W338E", "classCode": "ACTIB", "strengthNumerator": "65", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves minor aches and pains due to: headache muscular aches", "Purpose": "Pain reliever Pain reliever Pain reliever aid", "Purposes": "Pain reliever Pain reliever aid", "Warnings": "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. 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.", "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.", "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", "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", "Principal Display Panel (Excedrin Extra Strength)": "NDC 0067-2000-91 EXCEDRIN ® EXTRA STRENGTH Acetaminophen, Aspirin (NSAID) and Caffeine Pain Reliever / Pain Reliever Aid 100 CAPLETS TAMPER-EVIDENT BOTTLE DO NOT USE IF INNER FOIL SEAL IMPRINTED WITH “SEALED for YOUR PROTECTION” IS BROKEN OR MISSING Distributed by: GSK Consumer Healthcare, Warren, NJ 07059 ©2015 GSK group of companies or its licensor. All rights reserved. Visit us at www.excedrin.com DO NOT TAKE BOTH PRODUCTS AT THE SAME TIME. USE PRODUCTS AS DIRECTED. 46172044", "Principal Display Panel (Excedrin Tension Headache)": "NDC 0067-8139-01 EXCEDRIN ® TENSION HEADACHE Acetaminophen and Caffeine Pain Reliever / Pain Reliever Aid Aspirin Free 24 CAPLETS TAMPER-EVIDENT BOTTLE DO NOT USE IF INNER FOIL SEAL IMPRINTED WITH “SEALED for YOUR PROTECTION” IS BROKEN OR MISSING Distributed by: GSK Consumer Healthcare, Warren, NJ 07059 ©2016 GSK group of companies or its licensor. All rights reserved. Trademarks are owned by or licensed to the GSK group of companies Visit us at www.excedrin.com 46177299", "Ask a doctor or pharmacist before use if you are taking": "a prescription drug for diabetes, gout, or arthritis any other drug, or are under a doctor’s care for any serious condition"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:51.791557 · Updated: 2026-03-14T23:13:51.825108