Drug Facts

Drug Facts

SPL v1

SPL

SPL Set ID 2b9b13b5-b530-4359-b094-1708c7a8e6d5

Route

ORAL

Published

Effective Date 2012-06-05

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 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 FINAL Active Since 2010-01-27

Description

Diphenhydramine HCL 25 mg

Purpose

Antihistamine

How Supplied

Diphenhydramine HCL 25 mg Capsules Bottles of 10 NDC 54868-0026-5 Bottles of 20 NDC 54868-0026-6 Bottles of 30 NDC 54868-0026-1 Bottles of 60 NDC 54868-0026-7 Bottles of 90 NDC 54868-0026-8 Bottles of 100 NDC 54868-0026-0 Bottles of 1000 NDC 54868-0026-4 Relabeling and Repackaging by: Physicians Total Care, Inc. Tulsa, Oklahoma 74146

Medication Information

Purpose

Antihistamine

How Supplied

Diphenhydramine HCL 25 mg Capsules

Bottles of 10	NDC 54868-0026-5
Bottles of 20	NDC 54868-0026-6
Bottles of 30	NDC 54868-0026-1
Bottles of 60	NDC 54868-0026-7
Bottles of 90	NDC 54868-0026-8
Bottles of 100	NDC 54868-0026-0
Bottles of 1000	NDC 54868-0026-4

Relabeling and Repackaging by:

Physicians Total Care, Inc.

Tulsa, Oklahoma 74146

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.

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

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

Principal Display Panel

Diphenhydramine HCL Capsules

25 mg

When Using This Product

Avoid 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

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.

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 Capsules

Bottles of 10	NDC 54868-0026-5
Bottles of 20	NDC 54868-0026-6
Bottles of 30	NDC 54868-0026-1
Bottles of 60	NDC 54868-0026-7
Bottles of 90	NDC 54868-0026-8
Bottles of 100	NDC 54868-0026-0
Bottles of 1000	NDC 54868-0026-4

Relabeling and Repackaging by:

Physicians Total Care, Inc.

Tulsa, Oklahoma 74146

Other Information: (Other information:)

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

Inactive Ingredients: (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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Diphenhydramine HCL Capsules

25 mg

When Using This Product (When using this product)

Avoid 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

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", "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.", "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 Capsules Bottles of 10 NDC 54868-0026-5 Bottles of 20 NDC 54868-0026-6 Bottles of 30 NDC 54868-0026-1 Bottles of 60 NDC 54868-0026-7 Bottles of 90 NDC 54868-0026-8 Bottles of 100 NDC 54868-0026-0 Bottles of 1000 NDC 54868-0026-4 Relabeling and Repackaging by: Physicians Total Care, Inc. Tulsa, Oklahoma 74146", "Other information:": "Store at room temperature 15-30 degrees C (59-86 degrees F) Protect from excessive moisture", "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", "PRINCIPAL DISPLAY PANEL": "Diphenhydramine HCL Capsules 25 mg", "When using this product": "Avoid 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

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:55:29.151820 · Updated: 2026-03-14T22:53:10.919261