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

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

Medication Information

Active Ingredient

Diphenhydramine 25 mg

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

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

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

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

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.

Do Not Use

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

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

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

Active Ingredient (Active ingredient (in each tablet))

Diphenhydramine 25 mg

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

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

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)

How Supplied

They are supplied as follows:

NDC 68094-018-61

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

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.

Do Not Use (Do not use)

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

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

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

[{"name": "diphenhydramine", "unii": "8GTS82S83M", "classCode": "ACTIB", "strengthNumerator": "25", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "carnauba wax", "unii": "R12CBM0EIZ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "crospovidone (120 .MU.M)", "unii": "68401960MK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "D&C Red No. 27", "unii": "2LRS185U6K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSE, UNSPECIFIED", "unii": "3NXW29V3WO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Magnesium Stearate", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE CELLULOSE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL, UNSPECIFIED", "unii": "3WJQ0SDW1A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Polysorbate 80", "unii": "6OZP39ZG8H", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STEARIC ACID", "unii": "4ELV7Z65AP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Titanium dioxide", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "anhydrous dibasic calcium phosphate", "unii": "L11K75P92J", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"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", "42229-5": "25 mg Tablets For Hospital Use Only LI1729 Rev. 10/24 Drug Facts", "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).", "50568-5": "Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers", "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": "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": "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"}

Additional Information

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