Diphenhydramine Hydrochloride

Diphenhydramine Hydrochloride
SPL v5
SPL
SPL Set ID 4d0f4f5b-3135-4457-bb8f-ad9d28ca5ea4
Route
ORAL
Published
Effective Date 2025-09-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg)
Inactive Ingredients
Carnauba Wax Crospovidone (120 .mu.m) D&c Red No. 27 Hypromellose, Unspecified Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Polysorbate 80 Stearic Acid Titanium Dioxide Anhydrous Dibasic Calcium Phosphate

Identifiers & Packaging

Pill Appearance
Imprint: L479;25 Shape: oval Color: pink Size: 10 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-07-15
Description

25 mg Tablets For Hospital Use Only LI1729 Rev. 10/24 Drug Facts

Purpose

Antihistamine

How Supplied

They are supplied as follows: NDC 68094-018-61 Unit Dose Packages of 100 Tablets (10×10) per Carton

Medication Information

Purpose

Antihistamine

How Supplied

They are supplied as follows:

NDC 68094-018-61

Unit Dose Packages of 100 Tablets (10×10) per Carton

Description

25 mg Tablets For Hospital Use Only LI1729 Rev. 10/24 Drug Facts

Uses
  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    • runny nose
    • sneezing
    • itchy, watery eyes
    • itching of nose
  • temporarily relieves these symptoms due to the common cold:
    • runny nose
    • sneezing
Section 42229-5

25 mg Tablets

For Hospital Use Only

LI1729 Rev. 10/24

Drug Facts

Section 50565-1

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).

Section 50568-5

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Directions
  • Use as directed per healthcare professional.
  • take every 4 to 6 hours, or as directed by a doctor
  • do not take more than 6 doses in 24 hours
adults and children 12 years and older 1 to 2 tablets
children 6 to under 12 years 1 tablet
children under 6 years do not use
Do Not Use
  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin
Other Information
  • each tablet contains: calcium 20 mg
  • store at 20-25°C (68-77°F).
  • Avoid high humidity. Protect from light
  • small tablet size, easy to swallow
Inactive Ingredients

carnauba wax, crospovidone, D&C red no. 27 aluminum lake, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, stearic acid, titanium dioxide

Questions Or Comments?

1-800-397-9228

When Using This Product
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children
Active Ingredient (in Each Tablet)

Diphenhydramine 25 mg

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
Principal Display Panel 25 Mg Tablet Blister Pack Carton Label

PrecisionDose™

NDC 68094-018-61

Unit Dose

diphenhydrAMINE HCl

25 mg Tablets

100 Tablets

(10x10)

Each tablet contains:

Diphenhydramine Hydrochloride 25 mg

Calcium 20 mg

Gluten Free

USUAL DOSE: SEE ENCLOSED DRUG FACTS.

Store at 20-25°C (68-77°F).

Avoid high humidity. Protect from light.

Keep out of reach of children.

Hospital Use Only.

LC1733

R0

Packaged by:

Precision Dose, Inc.

South Beloit, IL 61080

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 nose
  • temporarily relieves these symptoms due to the common cold:
    • runny nose
    • sneezing
Section 42229-5 (42229-5)

25 mg Tablets

For Hospital Use Only

LI1729 Rev. 10/24

Drug Facts

Section 50565-1 (50565-1)

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).

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Purpose

Antihistamine

Directions
  • Use as directed per healthcare professional.
  • take every 4 to 6 hours, or as directed by a doctor
  • do not take more than 6 doses in 24 hours
adults and children 12 years and older 1 to 2 tablets
children 6 to under 12 years 1 tablet
children under 6 years do not use
Do Not Use (Do not use)
  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin
How Supplied

They are supplied as follows:

NDC 68094-018-61

Unit Dose Packages of 100 Tablets (10×10) per Carton

Other Information (Other information)
  • each tablet contains: calcium 20 mg
  • store at 20-25°C (68-77°F).
  • Avoid high humidity. Protect from light
  • small tablet size, easy to swallow
Inactive Ingredients (Inactive ingredients)

carnauba wax, crospovidone, D&C red no. 27 aluminum lake, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, stearic acid, titanium dioxide

Questions Or Comments? (Questions or comments?)

1-800-397-9228

When Using This Product (When using this product)
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children
Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Diphenhydramine 25 mg

Ask A Doctor Before Use If You Have (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
Principal Display Panel 25 Mg Tablet Blister Pack Carton Label (PRINCIPAL DISPLAY PANEL - 25 mg Tablet Blister Pack Carton Label)

PrecisionDose™

NDC 68094-018-61

Unit Dose

diphenhydrAMINE HCl

25 mg Tablets

100 Tablets

(10x10)

Each tablet contains:

Diphenhydramine Hydrochloride 25 mg

Calcium 20 mg

Gluten Free

USUAL DOSE: SEE ENCLOSED DRUG FACTS.

Store at 20-25°C (68-77°F).

Avoid high humidity. Protect from light.

Keep out of reach of children.

Hospital Use Only.

LC1733

R0

Packaged by:

Precision Dose, Inc.

South Beloit, IL 61080

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:07:01.211718 · Updated: 2026-03-14T23:10:11.873456