DIPHENHYDRAMINE HCL- diphenhydramine hydrochloride solution

Diphenhydramine HCl by

Drug Labeling and Warnings

Diphenhydramine HCl by is a Otc medication manufactured, distributed, or labeled by American Health Packaging. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (in each 10 mL cup)

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

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

Warnings

Do not use

• to make a child sleepy
• with 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 bronchitis
• glaucoma

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

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)

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

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

INGREDIENTS AND APPEARANCE

DIPHENHYDRAMINE HCL 
diphenhydramine hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60687-830
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	white (CLEAR)	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60687-830-56	10 in 1 CASE	08/04/2024
1	NDC: 60687-830-48	10 in 1 TRAY
1	NDC: 60687-830-42	10 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
2	NDC: 60687-830-08	3 in 1 CASE	08/04/2024
2	NDC: 60687-830-48	10 in 1 TRAY
2	NDC: 60687-830-42	10 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	08/04/2024

Labeler - American Health Packaging (929561009)