NDC 79903-050 Pain Reliever Pm

Acetaminophen, Diphenhydramine Hcl

NDC Product Code 79903-050

NDC 79903-050-09

Package Description: 1 BOTTLE, PLASTIC in 1 CARTON > 20 TABLET in 1 BOTTLE, PLASTIC

NDC 79903-050-31

Package Description: 80 TABLET in 1 BOTTLE, PLASTIC

NDC Product Information

Pain Reliever Pm with NDC 79903-050 is a a human over the counter drug product labeled by Walmart Inc.. The generic name of Pain Reliever Pm is acetaminophen, diphenhydramine hcl. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Walmart Inc.

Dosage Form: Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.

Product Type: Human Otc Drug 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.

Pain Reliever Pm Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • ACETAMINOPHEN 500 mg/1
  • DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1

Inactive Ingredient(s)

About the Inactive Ingredient(s)
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.

  • AMMONIA (UNII: 5138Q19F1X)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • FD&C RED NO. 3 (UNII: PN2ZH5LOQY)
  • GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
  • HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
  • HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
  • FERROSOFERRIC OXIDE (UNII: XM0M87F357)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • SHELLAC (UNII: 46N107B71O)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

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.

Labeler Name: Walmart Inc.
Labeler Code: 79903
FDA Application Number: part343 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.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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.

Start Marketing Date: 02-12-2021 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 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.

Exclude Flag: N 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Pain Reliever Pm Product Label Images

Pain Reliever Pm Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredients (In Each Gelcap)

Acetaminophen 500 mgDiphenhydramine HCl 25 mg

Purpose

Pain relieverNighttime 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 takemore than 4,000 mg of acetaminophen in 24 hourswith other drugs containing acetaminophen3 or more alcoholic drinks every day while using this productAllergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:skin reddeningblistersrashIf a skin reaction occurs, stop use and seek medical help right away.

Do Not Use

  • If you are allergic to acetaminophen or any of the inactive ingredients in this productwith any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.in children under 12 years of agewith any other product containing diphenhydramine, even one used on skin

Ask A Doctor Before Use If You Have

  • A breathing problem such as emphysema or chronic bronchitisliver diseaseglaucomadifficulty in urination due to enlargement of the prostate gland

Ask A Doctor Or Pharmacist Before Use If You Are

  • Taking the blood thinning drug warfarintaking sedatives or tranquilizers

When Using This Product

  • Drowsiness will occuravoid alcoholic beveragesdo not drive a motor vehicle or operate machinery

Stop Use And Ask A Doctor If

  • New symptoms occursleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.redness or swelling is presentpain gets worse or lasts more than 10 daysfever gets worse or lasts more than 3 daysThese could be signs of a serious condition.

If Pregnant Or Breast-Feeding,

Ask a health professional before use.

Keep Out Of Reach Of Children.

In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt 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 directedadults and children 12 years and overtake 2 gelcaps at bedtimedo not take more than 2 gelcaps of this product in 24 hourschildren under 12 years: do not use

Other Information

  • Store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)avoid high humidityuse by expiration date on package

Inactive Ingredients

Ammonium hydroxide, colloidal silicon dioxide, croscarmellose sodium, FD&C blue #1, FD&C red #3, gelatin, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, simethicone, stearic acid, titanium dioxide

* Please review the disclaimer below.