Diphenhydramine Hcl Oral Solution, Usp

Diphenhydramine Hcl Oral Solution, Usp
SPL v1
SPL
SPL Set ID b94feeb6-f33f-410d-a9b0-776b1ccf34a9
Route
ORAL
Published
Effective Date 2024-06-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg)
Inactive Ingredients
Anhydrous Citric Acid Glycerin Water Saccharin Sodium Sodium Benzoate Carboxymethylcellulose Sodium, Unspecified Sodium Citrate, Unspecified Form Sorbitol

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-08-04

Description

Diphenhydramine HCl 25 mg

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

Diphenhydramine HCl 25 mg

Uses
  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    • runny nose
    • sneezing
    • itchy, watery eyes
    • itching of the nose or throat
Section 50568-5

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

Do Not Use
  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin
Directions:
  • find right dose on chart below
  • mL = milliliter
  • take every 4 to 6 hours, or as directed by a doctor
  • do not take more than 6 doses in 24 hours
Age (yr) Dose (mL)

children under 2 years

do not use

children 2 to 5 years

do not use unless directed by a doctor

children 6 to 11 years

5 mL to 10 mL

Other Information
  • each 5 mL contains: sodium 10 mg
  • store between 20-25°C (68-77°F).

Diphenhydramine HCl Oral Solution, USP is a clear, cherry flavored liquid supplied in the following:

10 mL unit dose cups: 100 cups (10 x 10) NDC 60687-830-56

10 mL unit dose cups: 30 cups (3 x 10) NDC 60687-830-08

Inactive Ingredients:

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

Questions Or Comments?

Call 1-800-845-8210

DO NOT USE IF SEAL IS BROKEN.

Distributed by:

American Health Packaging

Columbus, OH 43217

R02/24

When Using This Product
  • marked drowsiness may occur
  • sedatives and tranquilizers may increase drowsiness
  • excitability may occur, especially in 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)

Active Ingredient (in Each 10 Ml Cup)

Diphenhydramine HCl 25 mg

Ask A Doctor Before Use If the Child Has
  • a breathing problem such as chronic bronchitis
  • glaucoma
Principal Display Panel Label 25 Mg/10 Ml

100 Count Case NDC 60687-830-56,

30 Count Case NDC 60687-830-08

Cup NDC 60687-830-42

Diphenhydramine Hydrochloride

Oral Solution USP

25 mg/10 mL

Antihistamine/Allergy

Alcohol Free/Dye Free/Sugar Free

Usual Dosage: See attached Drug Facts

Store at 20° to 25°C (68° to 77°F)

For Institutional Use Only

10 x 10 mL Unit-Dose Cups

T0865C100224            R02/24

Principal Display Panel – Cup – 25 Mg/10 Ml

NDC 60687- 830-42

Diphenhydramine Hydrochloride

Oral Solution USP

25 mg/10 mL

Antihistamine/Allergy

Alcohol Free/Dye Free/Sugar Free

Delivers 10 mL

Sodium Content: 20 mg/1 O ml

See package Drug Facts insert for full

prescribing information and storage.

For Institutional Use Only.

American Health Packaging

Columbus, OH 43217

A0865C100224


Structured Label Content

Uses
  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    • runny nose
    • sneezing
    • itchy, watery eyes
    • itching of the nose or throat
Section 50568-5 (50568-5)

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

Purpose

Antihistamine

Do Not Use (Do not use)
  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin
Directions:
  • find right dose on chart below
  • mL = milliliter
  • take every 4 to 6 hours, or as directed by a doctor
  • do not take more than 6 doses in 24 hours
Age (yr) Dose (mL)

children under 2 years

do not use

children 2 to 5 years

do not use unless directed by a doctor

children 6 to 11 years

5 mL to 10 mL

Other Information (Other information)
  • each 5 mL contains: sodium 10 mg
  • store between 20-25°C (68-77°F).

Diphenhydramine HCl Oral Solution, USP is a clear, cherry flavored liquid supplied in the following:

10 mL unit dose cups: 100 cups (10 x 10) NDC 60687-830-56

10 mL unit dose cups: 30 cups (3 x 10) NDC 60687-830-08

Inactive Ingredients: (Inactive ingredients:)

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

Questions Or Comments? (Questions or comments?)

Call 1-800-845-8210

DO NOT USE IF SEAL IS BROKEN.

Distributed by:

American Health Packaging

Columbus, OH 43217

R02/24

When Using This Product (When using this product)
  • marked drowsiness may occur
  • sedatives and tranquilizers may increase drowsiness
  • excitability may occur, especially in children
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)

Active Ingredient (in Each 10 Ml Cup) (Active ingredient (in each 10 mL cup))

Diphenhydramine HCl 25 mg

Ask A Doctor Before Use If the Child Has (Ask a doctor before use if the child has)
  • a breathing problem such as chronic bronchitis
  • glaucoma
Principal Display Panel Label 25 Mg/10 Ml (Principal Display Panel - Label - 25 mg/10 mL)

100 Count Case NDC 60687-830-56,

30 Count Case NDC 60687-830-08

Cup NDC 60687-830-42

Diphenhydramine Hydrochloride

Oral Solution USP

25 mg/10 mL

Antihistamine/Allergy

Alcohol Free/Dye Free/Sugar Free

Usual Dosage: See attached Drug Facts

Store at 20° to 25°C (68° to 77°F)

For Institutional Use Only

10 x 10 mL Unit-Dose Cups

T0865C100224            R02/24

Principal Display Panel – Cup – 25 Mg/10 Ml (Principal Display Panel – Cup – 25 mg/10 mL)

NDC 60687- 830-42

Diphenhydramine Hydrochloride

Oral Solution USP

25 mg/10 mL

Antihistamine/Allergy

Alcohol Free/Dye Free/Sugar Free

Delivers 10 mL

Sodium Content: 20 mg/1 O ml

See package Drug Facts insert for full

prescribing information and storage.

For Institutional Use Only.

American Health Packaging

Columbus, OH 43217

A0865C100224


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)