drug facts

drug facts
SPL v4
SPL
SPL Set ID e5c2d88a-d903-4ca0-b895-f27e791dfc4e
Route
oral
Published
Effective Date 2017-02-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
acetaminophen (500 mg) caffeine (65 mg)
Inactive Ingredients
benzoic acid d&c red no. 27 aluminum oxide fd&c blue no. 2 fd&c yellow no. 6 magnesium stearate microcrystalline cellulose polyethylene glycol, unspecified polyvinyl alcohol, unspecified povidone, unspecified starch, corn titanium dioxide stearic acid talc

Identifiers & Packaging

Pill Appearance
Imprint: ETH Shape: oval Color: red Size: 17 mm Score: 1
Marketing Status
otc monograph drug active Since 2017-03-01
Purpose

Pain reliever Pain reliever aid

Description

Acetaminophen 500 mg Caffeine 65 mg

Medication Information

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: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.

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(see overdose warming)
  • 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: ask a doctor
Other Information
  • store at 20°-25°C (68°-77°F)
  • close cap tightly after use
Inactive Ingredients

benzoic acid, D&C red #27 aluminum lake, FD&C blue #2 aluminum lake, FD&C yellow #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

Principal Display Panel

NDC 0135-0620-01

Panadol ®

EXTRA

ACETAMINOPHEN

Pain Reliever

CAFFEINE

Pain Reliever Aid

NEW

24 CAPLETS

TAMPER-EVIDENT BOTTLE

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

READ AND KEEP CARTON FOR COMPLETE INFORMATION

Distributed by: GSKConsumer 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.

62000000011138

Purposes

Pain reliever

Pain reliever aid

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

Questions Or Comments?

1-800-455-7139

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 occur

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

Caffeine 65 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

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: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.

Uses
  • temporarily relieves minor aches and pains due to:
    • headache
    • muscular aches
Directions
  • do not use more than directed(see overdose warming)
  • 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: ask a doctor
Other Information (Other information)
  • store at 20°-25°C (68°-77°F)
  • close cap tightly after use
Inactive Ingredients (Inactive ingredients)

benzoic acid, D&C red #27 aluminum lake, FD&C blue #2 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, stearic acid, talc titanium dioxide

Principal Display Panel

NDC 0135-0620-01

Panadol ®

EXTRA

ACETAMINOPHEN

Pain Reliever

CAFFEINE

Pain Reliever Aid

NEW

24 CAPLETS

TAMPER-EVIDENT BOTTLE

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

READ AND KEEP CARTON FOR COMPLETE INFORMATION

Distributed by: GSKConsumer 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.

62000000011138

Purposes

Pain reliever

Pain reliever aid

Do Not Use (Do not use)
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • if you are allergic to acetaminophen, caffeine or any of the other ingredients in this product
Overdose Warning: (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.

Questions Or Comments? (Questions or comments?)

1-800-455-7139

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 occur

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

Caffeine 65 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

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:46.099834 · Updated: 2026-03-14T23:02:29.359860