NDC 0135-7021 Panadol PM
Acetaminophen And Diphenhydramine Hcl Tablet, Film Coated Oral

Product Information

Panadol PM is a human over the counter drug product labeled by Glaxosmithkline Consumer Healthcare Holdings (us) Llc. The generic name of Panadol PM is acetaminophen and diphenhydramine hcl. The product's dosage form is tablet, film coated and is administered via oral form.

Product Code0135-7021
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Panadol PM
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Acetaminophen And Diphenhydramine Hcl
Product Type What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
Human Otc Drug
Dosage FormTablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route(s) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Oral - Administration to or by way of the mouth.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Glaxosmithkline Consumer Healthcare Holdings (us) Llc
Labeler Code0135
FDA Application Number What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
part343
Marketing Category What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
06-25-2021
Listing Expiration Date What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.
12-31-2023
Exclude Flag What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
N
NDC Code Structure

What are the uses for Panadol PM?


Product Characteristics

Color(s)BLUE (C48333)
ShapeOVAL (C48345)
Size(s)17 MM
Imprint(s)PAN;PM
Score1

Product Packages

NDC 0135-7021-01

Package Description: 50 PACKET in 1 CARTON > 2 TABLET, FILM COATED in 1 PACKET

NDC 0135-7021-02

Package Description: 1 BOTTLE in 1 CARTON > 24 TABLET, FILM COATED in 1 BOTTLE

NDC 0135-7021-03

Package Description: 1 BOTTLE in 1 CARTON > 50 TABLET, FILM COATED in 1 BOTTLE

Product Details

What are Panadol PM Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • ACETAMINOPHEN 500 mg/1 - Analgesic antipyretic derivative of acetanilide. It has weak anti-inflammatory properties and is used as a common analgesic, but may cause liver, blood cell, and kidney damage.
  • DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 - A histamine H1 antagonist used as an antiemetic, antitussive, for dermatoses and pruritus, for hypersensitivity reactions, as a hypnotic, an antiparkinson, and as an ingredient in common cold preparations. It has some undesired antimuscarinic and sedative effects.

Panadol PM Active Ingredients UNII Codes

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • RxCUI: 1092189 - acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral Tablet
  • RxCUI: 1092189 - acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral Tablet
  • RxCUI: 1092189 - APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral Tablet
  • RxCUI: 1094718 - Panadol PM EXTRA STRENGTH 500 MG / 25 MG Oral Tablet
  • RxCUI: 1094718 - acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral Tablet [Panadol PM]

Panadol PM Inactive Ingredients UNII Codes

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

Pharmacologic Class(es)

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

* Please review the disclaimer below.

Patient Education

Acetaminophen

Acetaminophen is pronounced as (a set a mee' noe fen)

Why is acetaminophen medication prescribed?
Acetaminophen is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to va...
[Read More]
Diphenhydramine

Diphenhydramine is pronounced as (dye fen hye' dra meen)
Why is diphenhydramine medication prescribed?
Diphenhydramine is used to relieve red, irritated, itchy, watery eyes; sneezing; and runny nose caused by hay fever, allergies, or the common cold. Diphenhydramine is als...
[Read More]

* Please review the disclaimer below.

Panadol PM Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Active Ingredients (In Each Caplet)



Acetaminophen 500 mg

Diphenhydramine HCl 25 mg


Purposes



Pain reliever

Nighttime sleep-aid


Uses



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

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
  • •be careful when driving a motor vehicle or operating 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.


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.


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

Other Information



  • •store at 25°C (77°F)

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, stearic acid, talc, titanium dioxide


Questions?



1-800-455-7139


Principal Display Panel



NDC 0135-7021-01

Panadol

EXTRA STRENGTH

PM

ACETAMNOPHEN

Pain Reliever

DIPHENHYDRAMINE HCl

Nighttime Sleep-Aid

2 CAPLETS

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

Fold Back And Tear To Open Or Use Scissors

Distributed by:

GSKConsumer Healthcare, Warren, NJ 07059

Trademarks owned or licensed by GSK.

©2021 GSK or licensor.

TR-0630-765-24 ORG


* Please review the disclaimer below.