NDC 0363-0715 Extra Strength Nite-time Pain Relief

430r Walgreens Acetaminophen 500 Mg, Diphenhydramine Hcl 25 Mg Tablet

NDC Product Code 0363-0715

NDC CODE: 0363-0715

Proprietary Name: Extra Strength Nite-time Pain Relief 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.

Non-Proprietary Name: 430r Walgreens Acetaminophen 500 Mg, Diphenhydramine Hcl 25 Mg Tablet 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.

Product Characteristics

Color(s):
BLUE (C48333)
Shape: CAPSULE (C48336)
Size(s):
20 MM
Imprint(s):
TCL430
Score: 1

NDC Code Structure

  • 0363 - Walgreens
    • 0363-0715 - Extra Strength Nite-time Pain Relief

NDC 0363-0715-01

Package Description: 1 BOTTLE in 1 CARTON > 100 TABLET in 1 BOTTLE

NDC Product Information

Extra Strength Nite-time Pain Relief with NDC 0363-0715 is a a human over the counter drug product labeled by Walgreens. The generic name of Extra Strength Nite-time Pain Relief is 430r walgreens acetaminophen 500 mg, diphenhydramine hcl 25 mg tablet. The product's dosage form is tablet and is administered via oral form.

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.

Extra Strength Nite-time Pain Relief 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.


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.

  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
  • POVIDONE (UNII: FZ989GH94E)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • TALC (UNII: 7SEV7J4R1U)
  • CARNAUBA WAX (UNII: R12CBM0EIZ)
  • FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
  • 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: Walgreens
Labeler Code: 0363
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: 10-12-2021 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 - NO 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".

* Please review the disclaimer below.

Extra Strength Nite-time Pain Relief Product Label Images

Extra Strength Nite-time Pain Relief 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

Otc - Active Ingredient

Active ingredients

(in each caplet)

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg

Otc - Purpose

Purpose
Pain reliever

Nighttime sleep aid

Indications & Usage

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

Warnings

  • WarningsLiver warning: This product contains acetaminophen. Severe liver damage may occur if you take
  • More 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.

Otc - Do Not Use

  • Do not usewith 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 skinin children under 12 years of ageif you have ever had an allergic reaction to this product or any of its ingredients

Otc - Ask Doctor

  • Ask a doctor before use if you haveliver diseasea breathing problem such as emphysema or chronic bronchitistrouble urinating due to an enlarged prostate glandglaucoma

Otc - Ask Doctor/Pharmacist

  • Ask a doctor or pharmacist before use if you aretaking the blood thinning drug warfarintaking sedatives or tranquilizers

Otc - When Using

  • When using this productdrowsiness will occuravoid alcoholic drinksdo not drive a motor vehicle or operate machinery

Otc - Stop Use

  • Stop use and ask a doctor ifsleeplessness 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 daysfever gets worse or lasts more than 3 daysredness or swelling is presentnew symptoms occurThese could be signs of a serious condition.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Dosage & Administration

  • Directionsdo not take more than directed (see overdose warning)adults and children 12 years and over:take 2 caplets at bedtimedo not take more than 2 caplets of this product in 24 hours.children under 12 years:do not use

Other Information

  • Other informationstore between 20-25°C (68-77°F)

Inactive Ingredient

Inactive ingredients carnauba wax, colloidal silicon dioxide, FD&C blue #1 aluminum lake, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, sodium starch glycolate**, stearic acid, talc, titanium dioxide

**may contain this ingredient

Otc - Questions

Questions or comments? call
1-877-290-4008

* Please review the disclaimer below.