Drug Facts

Drug Facts

SPL v7

SPL

SPL Set ID b2fe7f47-1a2e-40ee-8f8f-38f2028dce1b

Route

ORAL

Published

Effective Date 2020-12-08

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Acetaminophen (500 mg)

Inactive Ingredients

Carnauba Wax Hypromellose, Unspecified Polyethylene Glycol, Unspecified Povidone, Unspecified Starch, Corn Stearic Acid

Identifiers & Packaging

Pill Appearance

Shape: oval Color: white Size: 17 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2017-03-15

Description

Acetaminophen 500 mg

Purpose

Pain reliever/Fever reducer

Medication Information

Purpose

Pain reliever/Fever reducer

Description

Acetaminophen 500 mg

Uses

temporarily relieves minor aches and pains due to:
- headache
- backache
- muscular aches
- minor arthritis pain
temporarily reduces fever

Purposes

Pain reliever/Fever reducer

Warnings

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

Allergy alert:A‑cetaminophen 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.

Directions

do not take more than directed(see overdose warning)
adults and children 12 years of age and over: take 2 caplets every 6 hours, while symptoms persist or as directed by a doctor
do not take more than 8 caplets in 24 hours, unless directed by a doctor
children under 12 years of age: ask a doctor

Do Not Use

with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains a acetaminophen, ask a doctor or pharmacist.
if you are allergic to acetaminophen or any of the inactive ingredients in this product

Other Information

store below 25°C (77°F)

Overdose Warning:

Taking more than the recommended dose can cause serious health problems. 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.

Inactive Ingredients

carnauba wax, hypromellose, polyethylene glycol, povidone, pregelatinized starch, stearic acid

Questions Or Comments?

1-800-455-7139

Principal Display Panel

NDC 0135-0609-01

PANADOL

EXTRA STRENGTH

500

ACETAMINOPHEN

Pain Reliever

Fever Reducer

24 CAPLETS

Trademarks are owned by or licensed to the GSK group of companies.

Tamper-Evident Feature:Do not use if printed bottle seal (under cap) is missing or broken.

READ AND KEEP CARTON FOR COMPLETE INFORMATION

Distributed by:

GSKConsumer Healthcare, Warren, NJ 07059

101596D

Stop Use and Ask A Doctor If

pain gets worse or lasts more than 10 days
fever gets worse or lasts more than 3 days
redness or swelling is present
any new symptoms appear

These could be signs of a serious condition.

If Pregnant Or Breast Feeding,

ask a health professional before use.

Active Ingredient (in Each Caplet)

Acetaminophen 500 mg

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

Structured Label Content

Uses

temporarily relieves minor aches and pains due to:
- headache
- backache
- muscular aches
- minor arthritis pain
temporarily reduces fever

Purposes

Pain reliever/Fever reducer

Warnings

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

Allergy alert:A‑cetaminophen 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.

Directions

do not take more than directed(see overdose warning)
adults and children 12 years of age and over: take 2 caplets every 6 hours, while symptoms persist or as directed by a doctor
do not take more than 8 caplets in 24 hours, unless directed by a doctor
children under 12 years of age: ask a doctor

Do Not Use (Do not use)

with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains a acetaminophen, ask a doctor or pharmacist.
if you are allergic to acetaminophen or any of the inactive ingredients in this product

Other Information (Other information)

store below 25°C (77°F)

Overdose Warning: (Overdose warning:)

Inactive Ingredients (Inactive ingredients)

carnauba wax, hypromellose, polyethylene glycol, povidone, pregelatinized starch, stearic acid

Questions Or Comments? (Questions or comments?)

1-800-455-7139

Principal Display Panel

NDC 0135-0609-01

PANADOL

EXTRA STRENGTH

500

ACETAMINOPHEN

Pain Reliever

Fever Reducer

24 CAPLETS

Trademarks are owned by or licensed to the GSK group of companies.

Tamper-Evident Feature:Do not use if printed bottle seal (under cap) is missing or broken.

READ AND KEEP CARTON FOR COMPLETE INFORMATION

Distributed by:

GSKConsumer Healthcare, Warren, NJ 07059

101596D

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

pain gets worse or lasts more than 10 days
fever gets worse or lasts more than 3 days
redness or swelling is present
any new symptoms appear

These could be signs of a serious condition.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Active Ingredient (in Each Caplet) (Active ingredient (in each caplet))

Acetaminophen 500 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

liver disease

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

Advanced Ingredient Data

[{"name": "CARNAUBA WAX", "unii": "R12CBM0EIZ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSE, UNSPECIFIED", "unii": "3NXW29V3WO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL, UNSPECIFIED", "unii": "3WJQ0SDW1A", "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": "ACETAMINOPHEN", "unii": "362O9ITL9D", "classCode": "ACTIB", "strengthNumerator": "500", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves minor aches and pains due to: headache backache muscular aches minor arthritis pain temporarily reduces fever", "Purposes": "Pain reliever/Fever reducer", "Warnings": "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 Allergy alert: A‑cetaminophen 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.", "Directions": "do not take more than directed (see overdose warning) adults and children 12 years of age and over: take 2 caplets every 6 hours, while symptoms persist or as directed by a doctor do not take more than 8 caplets in 24 hours, unless directed by a doctor children under 12 years of age: ask a doctor", "Do not use": "with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains a acetaminophen, ask a doctor or pharmacist. if you are allergic to acetaminophen or any of the inactive ingredients in this product", "Other information": "store below 25°C (77°F)", "Overdose warning:": "Taking more than the recommended dose can cause serious health problems. 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.", "Inactive ingredients": "carnauba wax, hypromellose, polyethylene glycol, povidone, pregelatinized starch, stearic acid", "Questions or comments?": "1-800-455-7139", "Principal Display Panel": "NDC 0135-0609-01 PANADOL EXTRA STRENGTH 500 ACETAMINOPHEN Pain Reliever Fever Reducer 24 CAPLETS Trademarks are owned by or licensed to the GSK group of companies. Tamper-Evident Feature: Do not use if printed bottle seal (under cap) is missing or broken. READ AND KEEP CARTON FOR COMPLETE INFORMATION Distributed by: GSK Consumer Healthcare, Warren, NJ 07059 ©2016 GSK group of companies or its licensor. 101596D", "Stop use and ask a doctor if": "pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present any new symptoms appear These could be signs of a serious condition.", "If pregnant or breast-feeding,": "ask a health professional before use.", "Active ingredient (in each caplet)": "Acetaminophen 500 mg", "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"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:46.087744 · Updated: 2026-03-14T23:02:29.359860