NDC 70518-0861 Diphenhydramine Hydrochloride

NDC Product Code 70518-0861

NDC 70518-0861-0

Package Description: 30 CAPSULE in 1 BOTTLE, PLASTIC

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Diphenhydramine Hydrochloride with NDC 70518-0861 is a product labeled by Remedyrepack Inc.. The generic name of Diphenhydramine Hydrochloride is . The product's dosage form is and is administered via form.

Labeler Name: Remedyrepack Inc.

Dosage Form: -

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.

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.

  • D&C RED NO. 28 (UNII: 767IP0Y5NH)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • GELATIN (UNII: 2G86QN327L)
  • LACTOSE (UNII: J2B2A4N98G)
  • STARCH, CORN (UNII: O8232NY3SJ)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Remedyrepack Inc.
Labeler Code: 70518
Start Marketing Date: 11-22-2017 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: 12-31-2018 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: I 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’.

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Information for Patients

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]

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Diphenhydramine Hydrochloride Product Label Images

Diphenhydramine Hydrochloride 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 Ingredient (In Each Banded Capsule)

Diphenhydramine HCl… 25 mgDiphenhydramine HCl… 50 mg

Purpose

Antihistamine

Use

  • 25 MGTemporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
  • Runny nosesneezingitchy, watery eyesitchy throat and noseTemporarily relieves these symptoms due to the common cold:
  • Runny nosesneezing50 MGTemporarily relieves these symptoms due to hay fever or other upper respiratory allergies and common cold
  • Sneezingrunny noseitchy, watery eyesitchy throat and nose

Warnings

  • Do not use 25 MGto make a child sleepywith any other product containing diphenhydramine, even one used on skin50 MGto make a child sleepywith any other product containing diphenhydramine, including one applied topically

Ask A Doctor Before Use If You Have

  • 25 MGa breathing problem such as emphysema or chronic bronchitisglaucomatrouble urinating due to an enlarged prostate gland50 MGglaucomaa breathing problem such as emphysema or chronic bronchitisdifficulty in urination due to enlargement of the prostate gland

Ask A Doctor Or Pharmacist

Before use if you are taking sedatives or tranquilizers

When Using This Product

  • Marked drowsiness may occuravoid alcoholic drinksalcohol, sedatives, and tranquilizers may increase drowsinessbe careful when driving a motor vehicle or operating machineryexcitability may occur, especially in children

If Pregnant Or Breast-Feeding

Ask a health professional before use.

Keep Out Of Reach Of Children

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

  • Take every 4-6 hoursDo not take more than 6 doses in 24 hours25 MG adults and children 12 years of age and over1 to 2 capsuleschildren 6 years to under 12 years of age1 capsulechildren under 6 years of agedo not use this product in children under 6 years of age50 MG adults and children 12 years of age and over1 capsulechildren 6 years to under 12 years of ageAsk a doctor, the proper dosage strength is not available in this package****Do not attempt to break capsules. The proper dosage strength and dosing information for children under 12 years of age is available on the 25 mg package.

Other Information

  • Store at 20°C – 25°C (68°F – 77°F); excursions permitted to 15° – 30°C (59° – 86°F) [See USP Controlled Room Temperature]Protect from moistureContains lactose

Inactive Ingredients

D&C Red #28, FD&C Blue #1, FD&C Red #40, Gelatin, Lactose and Starch.

Questions?

Questions or comments? (800) 616-2471

Distributed By

MAJOR® PHARMACEUTICALS


17177 N Laurel Park Drive, Suite 233,


Livonia, MI 48152

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