Drug Facts

Drug Facts

SPL v5

SPL

SPL Set ID 59aeb692-2f79-45aa-8e6a-dab77cd3b2f9

Route

ORAL

Published

Effective Date 2024-05-28

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Diphenhydramine (25 mg)

Inactive Ingredients

Ferrosoferric Oxide D&c Red No. 28 Fd&c Blue No. 1 Fd&c Red No. 40 Gelatin, Unspecified Lactose Monohydrate Magnesium Stearate Silicon Dioxide Sodium Lauryl Sulfate

Identifiers & Packaging

Pill Appearance

Imprint: PH014 Shape: capsule Color: pink Size: 14 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2010-01-27

Description

Diphenhydramine HCL 25 mg

Purpose

Antihistamine

How Supplied

Diphenhydramine HCl 25 mg NDC: 71335-0352-1: 30 Capsules in a BOTTLE NDC: 71335-0352-2: 20 Capsules in a BOTTLE NDC: 71335-0352-3: 42 Capsules in a BOTTLE NDC: 71335-0352-4: 24 Capsules in a BOTTLE NDC: 71335-0352-5: 15 Capsules in a BOTTLE NDC: 71335-0352-6: 60 Capsules in a BOTTLE NDC: 71335-0352-7: 10 Capsules in a BOTTLE NDC: 71335-0352-8: 6 Capsules in a BOTTLE NDC: 71335-0352-9: 90 Capsules in a BOTTLE NDC: 71335-0352-0: 100 Capsules in a BOTTLE Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

Medication Information

Purpose

Antihistamine

How Supplied

Diphenhydramine HCl 25 mg

NDC: 71335-0352-1: 30 Capsules in a BOTTLE
NDC: 71335-0352-2: 20 Capsules in a BOTTLE
NDC: 71335-0352-3: 42 Capsules in a BOTTLE
NDC: 71335-0352-4: 24 Capsules in a BOTTLE
NDC: 71335-0352-5: 15 Capsules in a BOTTLE
NDC: 71335-0352-6: 60 Capsules in a BOTTLE
NDC: 71335-0352-7: 10 Capsules in a BOTTLE
NDC: 71335-0352-8: 6 Capsules in a BOTTLE
NDC: 71335-0352-9: 90 Capsules in a BOTTLE
NDC: 71335-0352-0: 100 Capsules in a BOTTLE

Repackaged/Relabeled by:

Bryant Ranch Prepack, Inc.

Burbank, CA 91504

Description

Diphenhydramine HCL 25 mg

Uses:

Temporarily relieves these symptoms associated with the common cold, hay fever, or other respiratory allergies.

sneezing
nasal congestion
runny nose
itchy, watery eyes

Section 51945-4

Diphenhydramine HCl Capsules 25 mg

Warnings:

Do Not Use

With any other product containing Diphenhydramine HCL, including one applied topically.

Directions:

Take every 4-6 hours
Do not take more than 6 doses in 24 hours.

Adults and children 12 years or over	1 to 2 capsule
Children 6 to under 12 years	1 capsule
Children under 6 years	ask a doctor

Other Information:

Store at room temperature 15-30 degrees C (59-86 degrees F)
Protect from excessive moisture

When Using This Product

aAvoid 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.

Keep Out of Reach of Children

In case of overdose, get medical help or contact a Poison Control Center right away.

If Pregnant Or Breast Feeding,

ask a health professional before use.

Active Ingredient (in Each Capsule)

Diphenhydramine HCL 25 mg

Ask A Doctor Or Pharmacist Before Use

If you have

trouble urinating due to enlarged prostate gland
a breathing problem such as emphysema or chronic bronchitis
glaucoma
if you are taking sedatives or tranquilizers

Inactive Ingredients: Black Iron Oxide, D & C Red #28, Fd & C Blue #1, Fd & C Red #40, Gelatin, Lactose Monohydrate, Magnesium Stearate, Silicon Dioxide, Sodium Lauryl Sulfate

Structured Label Content

Uses:

Temporarily relieves these symptoms associated with the common cold, hay fever, or other respiratory allergies.

sneezing
nasal congestion
runny nose
itchy, watery eyes

Section 51945-4 (51945-4)

Diphenhydramine HCl Capsules 25 mg

Purpose

Antihistamine

Warnings:

Do Not Use (Do not use)

With any other product containing Diphenhydramine HCL, including one applied topically.

Directions:

Take every 4-6 hours
Do not take more than 6 doses in 24 hours.

Adults and children 12 years or over	1 to 2 capsule
Children 6 to under 12 years	1 capsule
Children under 6 years	ask a doctor

How Supplied (HOW SUPPLIED)

Diphenhydramine HCl 25 mg

NDC: 71335-0352-1: 30 Capsules in a BOTTLE
NDC: 71335-0352-2: 20 Capsules in a BOTTLE
NDC: 71335-0352-3: 42 Capsules in a BOTTLE
NDC: 71335-0352-4: 24 Capsules in a BOTTLE
NDC: 71335-0352-5: 15 Capsules in a BOTTLE
NDC: 71335-0352-6: 60 Capsules in a BOTTLE
NDC: 71335-0352-7: 10 Capsules in a BOTTLE
NDC: 71335-0352-8: 6 Capsules in a BOTTLE
NDC: 71335-0352-9: 90 Capsules in a BOTTLE
NDC: 71335-0352-0: 100 Capsules in a BOTTLE

Repackaged/Relabeled by:

Bryant Ranch Prepack, Inc.

Burbank, CA 91504

Other Information: (Other information:)

Store at room temperature 15-30 degrees C (59-86 degrees F)
Protect from excessive moisture

When Using This Product (When using this product)

aAvoid 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.

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.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Active Ingredient (in Each Capsule) (Active ingredient (in each capsule))

Diphenhydramine HCL 25 mg

Ask A Doctor Or Pharmacist Before Use (Ask a doctor or pharmacist before use)

If you have

trouble urinating due to enlarged prostate gland
a breathing problem such as emphysema or chronic bronchitis
glaucoma
if you are taking sedatives or tranquilizers

Inactive Ingredients: Black Iron Oxide, D & C Red #28, Fd & C Blue #1, Fd & C Red #40, Gelatin, Lactose Monohydrate, Magnesium Stearate, Silicon Dioxide, Sodium Lauryl Sulfate (Inactive ingredients: Black Iron Oxide, D & C Red #28, FD & C Blue #1, FD & C Red #40, Gelatin, Lactose Monohydrate, Magnesium Stearate, Silicon Dioxide, Sodium Lauryl Sulfate)

Advanced Ingredient Data

[{"name": "DIPHENHYDRAMINE", "unii": "8GTS82S83M", "classCode": "ACTIB", "strengthNumerator": "25", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "FERROSOFERRIC OXIDE", "unii": "XM0M87F357", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "D&C RED NO. 28", "unii": "767IP0Y5NH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GELATIN, UNSPECIFIED", "unii": "2G86QN327L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LACTOSE MONOHYDRATE", "unii": "EWQ57Q8I5X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM LAURYL SULFATE", "unii": "368GB5141J", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses:": "Temporarily relieves these symptoms associated with the common cold, hay fever, or other respiratory allergies. sneezing nasal congestion runny nose itchy, watery eyes", "51945-4": "Diphenhydramine HCl Capsules 25 mg", "Purpose": "Antihistamine", "Do not use": "With any other product containing Diphenhydramine HCL, including one applied topically.", "Directions:": "Take every 4-6 hours Do not take more than 6 doses in 24 hours. Adults and children 12 years or over 1 to 2 capsule Children 6 to under 12 years 1 capsule Children under 6 years ask a doctor", "HOW SUPPLIED": "Diphenhydramine HCl 25 mg NDC: 71335-0352-1: 30 Capsules in a BOTTLE NDC: 71335-0352-2: 20 Capsules in a BOTTLE NDC: 71335-0352-3: 42 Capsules in a BOTTLE NDC: 71335-0352-4: 24 Capsules in a BOTTLE NDC: 71335-0352-5: 15 Capsules in a BOTTLE NDC: 71335-0352-6: 60 Capsules in a BOTTLE NDC: 71335-0352-7: 10 Capsules in a BOTTLE NDC: 71335-0352-8: 6 Capsules in a BOTTLE NDC: 71335-0352-9: 90 Capsules in a BOTTLE NDC: 71335-0352-0: 100 Capsules in a BOTTLE Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504", "Other information:": "Store at room temperature 15-30 degrees C (59-86 degrees F) Protect from excessive moisture", "When using this product": "aAvoid 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.", "Keep out of reach of children": "In case of overdose, get medical help or contact a Poison Control Center right away.", "If pregnant or breast-feeding,": "ask a health professional before use.", "Active ingredient (in each capsule)": "Diphenhydramine HCL 25 mg", "Ask a doctor or pharmacist before use": "If you have trouble urinating due to enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis glaucoma if you are taking sedatives or tranquilizers"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:48.474618 · Updated: 2026-03-14T23:08:08.103878