NDC 0904-6985 Diphenhydramine Hcl

Diphenhydramine Hcl

NDC Product Code 0904-6985

NDC 0904-6985-16

Package Description: 473 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Diphenhydramine Hcl with NDC 0904-6985 is a a human over the counter drug product labeled by Major Pharmaceuticals. The generic name of Diphenhydramine Hcl is diphenhydramine hcl. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Major Pharmaceuticals

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Diphenhydramine Hcl 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.

  • DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL

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.

  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • D&C RED NO. 33 (UNII: 9DBA0SBB0L)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
  • SUCROSE (UNII: C151H8M554)

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: Major Pharmaceuticals
Labeler Code: 0904
FDA Application Number: part341 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 FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 08-27-2019 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: 12-31-2020 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.

Diphenhydramine Hcl Product Label Images

Diphenhydramine Hcl 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 Teaspoonful (5 Ml))

Diphenhydramine HCl 12.5 mg

Purpose

Antihistamine

Uses

  • Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:runny nosesneezingitchy, watery eyesitching of the nose or throat

Do Not Use

  • To make a child sleepywith 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 bronchitisglaucomadifficulty 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

  • Avoid alcoholic beveragesalcohol, sedatives, and tranquilizers may increase drowsinessexcitability may occur, especially in childrenmarked drowsiness may occuruse caution when driving a motor vehicle or operating machinery

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 (1-800-222-1222) right away.

Directions

  • Do not take more than 6 doses in 24 hoursmL = milliliter; FL OZ = fluid ouncefind right dose on chart belowtake every 4 to 6 hours, or as directed by a doctorAgeDoseadults and children 12 years and over2 - 4 teaspoonsful (25 mg to 50 mg)children 6 to 11 years1 - 2 teaspoonsful (12.5 mg to 25 mg)children 2 to 5 yearsdo not use unless directed by a doctorchildren under 2 yearsdo not use

Other Information

  • Each teaspoonful (5 mL) contains: sodium 5 mgstore at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)use by expiration date on package

Inactive Ingredients

Anhydrous citric acid, D&C red #33, FD&C red #40, flavors, glycerin, high fructose corn syrup, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sucrose

* Please review the disclaimer below.