Diphenhydramine Hydrochloride
FDA Label NDC 54868-5622

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Physicians Total Care, Inc. for the product Diphenhydramine Hydrochloride (NDC 54868-5622). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient (in each 5 ml teaspoonful), purpose, uses, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each 5 Ml Teaspoonful)

Diphenhydramine HCl 12.5 mg

Purpose

Antihistamine

Uses

  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
  • sneezing
  • itching of the nose or throat
  • runny nose
  • itchy, watery eyes
  • temporarily relieves these symptoms due to the common cold:
  • sneezing
  • runny nose

Do Not Use

  • with any other product containing diphenhydramine, even one used on skin
  • to make a child sleepy

Ask A Doctor Before Use If You Have

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a sodium-restricted diet

Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers

When Using This Product

  • avoid alcoholic drinks
  • marked drowsiness may occur
  • excitability may occur, especially in children
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • be careful 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 right away.

Directions

  • if needed, take every 4-6 hours
  • do not take more than 6 doses in 24 hours

    • children under 4

    years of age    		do not use

    children 4 to under 6

    years of age    		do not use unless directed by a doctor

    children 6 to under

    12 years of age

    1 to 2 teaspoonfuls

    (12.5 mg to 25 mg)

    adults and children

    12 years of age

    and over

    2 to 4 teaspoonfuls

    (25 mg to 50 mg)

Other Information

  • each teaspoonful contains: sodium 15 mg
  • store at 20°-25°C (68°-77°F)

Inactive Ingredients

citric acid, D&C red no. 33, FD&C red no. 40, flavor, glycerin, high fructose corn syrup, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sorbitol

Questions Or Comments?

1-800-719-9260

Principal Display Panel


Diphenhydramine Hydrochloride

12.5 mg/ 5 mL

NDC 54868-5622-0

Image Of Package Label (5622)

Image Of Package Label (5622)


Relieves:

Sneezing

Itchy, Watery Eyes

Runny Nose

Itchy Throat

See New Warning and Dosing Directions

Cherry Flavored

4 fl oz (118 mL)

Alcohol Free



Additional barcode labeling by:
Physicians Total Care, Inc.
Tulsa, Oklahoma      74146

* Please review the disclaimer below.