NDC 0121-0865 Diphenhydramine Hcl Oral Solution

Diphenhydramine Hydrochloride

NDC Product Code 0121-0865

NDC 0121-0865-00

Package Description: 10 TRAY in 1 CASE > 10 CUP, UNIT-DOSE in 1 TRAY > 5 mL in 1 CUP, UNIT-DOSE (0121-0865-05)

NDC 0121-0865-30

Package Description: 3 TRAY in 1 CASE > 10 CUP, UNIT-DOSE in 1 TRAY > 5 mL in 1 CUP, UNIT-DOSE (0121-0865-05)

NDC Product Information

Diphenhydramine Hcl Oral Solution with NDC 0121-0865 is a a human over the counter drug product labeled by Pharmaceutical Associates, Inc.. The generic name of Diphenhydramine Hcl Oral Solution is diphenhydramine hydrochloride. The product's dosage form is solution and is administered via oral form.

Labeler Name: Pharmaceutical Associates, Inc.

Dosage Form: Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

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 Oral Solution 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)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • WATER (UNII: 059QF0KO0R)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
  • SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
  • SORBITOL (UNII: 506T60A25R)

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.
  • 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: Pharmaceutical Associates, Inc.
Labeler Code: 0121
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: 06-18-2020 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: 12-31-2021 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 Oral Solution 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

Other

Drug Facts

Active Ingredient (In Each 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 The Child Has

  • A breathing problem such as chronic bronchitisglaucoma

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers

When Using This Product

  • Marked drowsiness may occursedatives and tranquilizers may increase drowsinessexcitability may occur, especially in children

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

  • Find right dose on chart belowmL = millilitertake every 4 to 6 hours, or as directed by a doctordo not take more than 6 doses in 24 hoursAge (yr)Dose (mL)children under 2 yearsdo not usechildren 2 to 5 yearsdo not use unless directed by a doctorchildren 6 to 11 years5 mL to 10 mLAttention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

Other Information

  • Each 5 mL contains: sodium 10 mg
  • Store between 20-25°C (68-77°F). Protect from light. Store in outer carton until contents used.

Inactive Ingredients

Citric acid anhydrous, glycerin, flavoring, purified water, saccharin sodium, sodium benzoate, sodium carboxymethylcellulose, sodium citrate, sorbitol.

* Please review the disclaimer below.