PANADOL PM ACETAMINOPHEN AND DIPHENHYDRAMINE HCL HALEON US HOLDINGS LLC FDA Approved Uses temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
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Substance Acetaminophen
Route
ORAL
Applications
M013

Drug Facts

Composition & Profile

Active Ingredients
Active ingredients (in each caplet) Acetaminophen 500 mg Diphenhydramine HCl 25 mg
Inactive Ingredients
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
Strengths
500 mg 25 mg
Treats Conditions
Uses Temporary Relief Of Occasional Headaches And Minor Aches And Pains With Accompanying Sleeplessness
Pill Appearance
Shape: oval Color: blue Imprint: PAN;PM

Identifiers & Packaging

Container Type BOX
UNII
362O9ITL9D TC2D6JAD40
Packaging

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 Panadol PM 50 ct

Package Descriptions
  • 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 Panadol PM 50 ct

Overview

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

Indications & Usage

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

Dosage & Administration

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

Warnings & Precautions
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 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. 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 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 Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin sedatives or tranquilizers 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. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. 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.
Adverse Reactions

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.

Purpose

Purposes Pain reliever Nighttime sleep-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. 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

When Using

When using this product drowsiness will occur avoid alcoholic drinks do not drive a motor vehicle or operate machinery

Stop Use & Ask a Doctor

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.

Keep Out of Reach of Children

Keep out of reach of children.

Storage & Handling

Other information (2 caplets) store at 25°C (77°F) Other information (24 and 50 caplets) store at 25°C (77°F) close cap tightly after use

Questions

Questions? 1-800-455-7139


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