Drug Facts

Drug Facts

SPL v4

SPL

SPL Set ID fe7cd1f2-9b00-4ded-99c2-8a152c71093c

Route

ORAL

Published

Effective Date 2022-04-26

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Acetaminophen (500 mg) Diphenhydramine (25 mg)

Inactive Ingredients

Silicon Dioxide Croscarmellose Sodium Fd&c Blue No. 1 Aluminum Oxide Microcrystalline Cellulose Polyethylene Glycol, Unspecified Polyvinyl Acetate Hypromellose, Unspecified Povidone, Unspecified Starch, Corn Stearic Acid Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance

Imprint: PAN;PM Shape: oval Color: blue Size: 17 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2021-06-25

Description

Acetaminophen 500 mg Diphenhydramine HCl 25 mg

Purpose

Pain reliever Nighttime sleep-aid

Medication Information

Purpose

Pain reliever Nighttime sleep-aid

Description

Acetaminophen 500 mg Diphenhydramine HCl 25 mg

Uses

temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness

Purposes

Pain reliever

Nighttime sleep-aid

Warnings

Liver warning:This product contains acetaminophen. Severe liver damage may occur if you take

more than 4,000 mg of acetaminophen in 24 hours
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product

Directions

do not take more than directed(see overdose warning)
adults and children 12 years of age and over: take 2 caplets at bedtime, if needed, or as directed by a doctor
do not give to children under 12 years of age

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.
with any other product containing diphenhydramine, even one used on skin
in children under 12 years of age
if you are allergic to acetaminophen or any of the inactive ingredients in this product

Questions?

1-800-455-7139

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.

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

colloidal silicon dioxide, croscarmellose sodium, FD&C blue no. 1 aluminum lake, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, stearic acid, talc, titanium dioxide

Principal Display Panel

NDC 0135-7021-03

Panadol

EXTRA STRENGTH

ACETAMNOPHEN

Pain Reliever

DIPHENHYDRAMINE HCl

Nighttime Sleep-Aid

50 CAPLETS

Tamper-Evident Feature:Do not use if printed inner safety seal under cap is broken or missing.

READ AND KEEP CARTON FOR COMPLETE INFORMATION

Dist. by: GSK Consumer Healthcare

Warren, NJ 07059

Trademarks owned or licensed by GSK.

B-0630-765-08 ORG

When Using This Product

drowsiness will occur
avoid alcoholic drinks
do not drive a motor vehicle or operate machinery

Stop Use and Ask A Doctor If

sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
pain gets worse or lasts more than 10 days
redness or swelling is present
any new symptoms appear

These could be signs of a serious condition.

Other Information (2 Caplets)

store at 25°C (77°F)

If Pregnant Or Breast Feeding,

ask a health professional before use.

Additional Information (2 Caplets)

TAMPER-EVIDENT FEATURE: DO NOT USE IF PACKET IS DAMAGED OR OPEN

Fold Back And Tear To Open Or Use Scissors

Dist. by: GSK Consumer Healthcare,Warren, NJ 07059

Trademarks owned or licensed by GSK.

Active Ingredients (in Each Caplet)

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg

Ask A Doctor Before Use If You Have

liver disease
glaucoma
a breathing problem such as emphysema or chronic bronchitis
trouble urinating due to an enlarged prostate gland

Other Information (24 and 50 Caplets)

store at 25°C (77°F)
close cap tightly after use

Additional Information ( (24 and 50 Caplets)

Tamper-Evident Feature:Do not use if printed inner safety seal under cap is broken or missing.

READ AND KEEP CARTON FOR COMPLETE INFORMATION

Dist. by: GSK Consumer Healthcare

Warren, NJ 07059

Trademarks owned or licensed by GSK.

Ask A Doctor Or Pharmacist Before Use If You Are Taking

the blood thinning drug warfarin
sedatives or tranquilizers

Structured Label Content

Uses

temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness

Purposes

Pain reliever

Nighttime sleep-aid

Warnings

Liver warning:This product contains acetaminophen. Severe liver damage may occur if you take

more than 4,000 mg of acetaminophen in 24 hours
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product

Directions

do not take more than directed(see overdose warning)
adults and children 12 years of age and over: take 2 caplets at bedtime, if needed, or as directed by a doctor
do not give to children under 12 years of age

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.
with any other product containing diphenhydramine, even one used on skin
in children under 12 years of age
if you are allergic to acetaminophen or any of the inactive ingredients in this product

Questions?

1-800-455-7139

Allergy Alert: (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.

Overdose Warning: (Overdose warning:)

Inactive Ingredients (Inactive ingredients)

Principal Display Panel

NDC 0135-7021-03

Panadol

EXTRA STRENGTH

ACETAMNOPHEN

Pain Reliever

DIPHENHYDRAMINE HCl

Nighttime Sleep-Aid

50 CAPLETS

Tamper-Evident Feature:Do not use if printed inner safety seal under cap is broken or missing.

READ AND KEEP CARTON FOR COMPLETE INFORMATION

Dist. by: GSK Consumer Healthcare

Warren, NJ 07059

Trademarks owned or licensed by GSK.

B-0630-765-08 ORG

When Using This Product (When using this product)

drowsiness will occur
avoid alcoholic drinks
do not drive a motor vehicle or operate machinery

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

sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
pain gets worse or lasts more than 10 days
redness or swelling is present
any new symptoms appear

These could be signs of a serious condition.

Other Information (2 Caplets) (Other information (2 caplets))

store at 25°C (77°F)

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

ask a health professional before use.

Additional Information (2 Caplets) (Additional Information (2 caplets))

TAMPER-EVIDENT FEATURE: DO NOT USE IF PACKET IS DAMAGED OR OPEN

Fold Back And Tear To Open Or Use Scissors

Dist. by: GSK Consumer Healthcare,Warren, NJ 07059

Trademarks owned or licensed by GSK.

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

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg

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

liver disease
glaucoma
a breathing problem such as emphysema or chronic bronchitis
trouble urinating due to an enlarged prostate gland

Other Information (24 and 50 Caplets) (Other information (24 and 50 caplets))

store at 25°C (77°F)
close cap tightly after use

Additional Information ( (24 and 50 Caplets) (Additional Information ( (24 and 50 caplets))

Tamper-Evident Feature:Do not use if printed inner safety seal under cap is broken or missing.

READ AND KEEP CARTON FOR COMPLETE INFORMATION

Dist. by: GSK Consumer Healthcare

Warren, NJ 07059

Trademarks owned or licensed by GSK.

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

the blood thinning drug warfarin
sedatives or tranquilizers

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness", "Purposes": "Pain reliever Nighttime sleep-aid", "Warnings": "Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product", "Directions": "do not take more than directed (see overdose warning) adults and children 12 years of age and over: take 2 caplets at bedtime, if needed, or as directed by a doctor do not give to children under 12 years of age", "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. with any other product containing diphenhydramine, even one used on skin in children under 12 years of age if you are allergic to acetaminophen or any of the inactive ingredients in this product", "Questions?": "1-800-455-7139", "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.", "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": "colloidal silicon dioxide, croscarmellose sodium, FD&C blue no. 1 aluminum lake, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, stearic acid, talc, titanium dioxide", "Principal Display Panel": "NDC 0135-7021-03 Panadol EXTRA STRENGTH PM ACETAMNOPHEN Pain Reliever DIPHENHYDRAMINE HCl Nighttime Sleep-Aid 50 CAPLETS Tamper-Evident Feature: Do not use if printed inner safety seal under cap is broken or missing. READ AND KEEP CARTON FOR COMPLETE INFORMATION Dist. by: GSK Consumer Healthcare Warren, NJ 07059 Trademarks owned or licensed by GSK. ©2021 GSK or licensor. B-0630-765-08 ORG", "When using this product": "drowsiness will occur avoid alcoholic drinks do not drive a motor vehicle or operate machinery", "Stop use and ask a doctor if": "sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness. pain gets worse or lasts more than 10 days redness or swelling is present any new symptoms appear These could be signs of a serious condition.", "Other information (2 caplets)": "store at 25°C (77°F)", "If pregnant or breast-feeding,": "ask a health professional before use.", "Additional Information (2 caplets)": "TAMPER-EVIDENT FEATURE: DO NOT USE IF PACKET IS DAMAGED OR OPEN Fold Back And Tear To Open Or Use Scissors Dist. by: GSK Consumer Healthcare, Warren, NJ 07059 Trademarks owned or licensed by GSK. ©2021 GSK or licensor.", "Active ingredients (in each caplet)": "Acetaminophen 500 mg Diphenhydramine HCl 25 mg", "Ask a doctor before use if you have": "liver disease glaucoma a breathing problem such as emphysema or chronic bronchitis trouble urinating due to an enlarged prostate gland", "Other information (24 and 50 caplets)": "store at 25°C (77°F) close cap tightly after use", "Additional Information ( (24 and 50 caplets)": "Tamper-Evident Feature: Do not use if printed inner safety seal under cap is broken or missing. READ AND KEEP CARTON FOR COMPLETE INFORMATION Dist. by: GSK Consumer Healthcare Warren, NJ 07059 Trademarks owned or licensed by GSK. ©2021 GSK or licensor.", "Ask a doctor or pharmacist before use if you are taking": "the blood thinning drug warfarin sedatives or tranquilizers"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:46.114618 · Updated: 2026-03-14T23:02:29.359860