0835&0836(box unit)-major

SPL v1

SPL

SPL Set ID 7db1790f-0bbb-4a29-8451-e7208fa43880

Route

oral

Published

Effective Date 2021-03-01

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

diphenhydramine (25 mg)

Inactive Ingredients

d&c red no. 28 fd&c blue no. 1 fd&c red no. 40 gelatin, unspecified anhydrous lactose starch, corn

Identifiers & Packaging

Pill Appearance

Imprint: CPC;835 Shape: capsule Color: pink Size: 14 mm Score: 1

Marketing Status

otc monograph final active Since 2009-01-02

Purpose

Antihistamine

How Supplied

Product: 50090-3788 NDC: 50090-3788-0 8 CAPSULE in a BOTTLE NDC: 50090-3788-1 10 CAPSULE in a BOTTLE

Description

Diphenhydramine HCl… 25 mg Diphenhydramine HCl… 50 mg

Medication Information

Warnings

Do not use

25 MG

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

50 MG

to make a child sleepy
with any other product containing diphenhydramine, including one applied topically

Purpose

Antihistamine

Directions

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

25 MG

adults and children 12 years of age and over	1 to 2 capsules
children 6 years to under 12 years of age	1 capsule
children under 6 years of age	do not use this product in children under 6 years of age

50 MG

adults and children 12 years of age and over	1 capsule
children 6 years to under 12 years of age	Ask a doctor, the proper dosage strength is not available in this package**

**Do not attempt to break capsules. The proper dosage strength and dosing information for children under 12 years of age is available on the 25 mg package.

Other Information

Store at 20°C – 25°C (68°F – 77°F); excursions permitted to 15° – 30°C (59° – 86°F) [See USP Controlled Room Temperature]
Protect from moisture
Contains lactose

Inactive Ingredients

D&C Red #28, FD&C Blue #1, FD&C Red #40, Gelatin, Lactose and Starch.

How Supplied

Product: 50090-3788

NDC: 50090-3788-0 8 CAPSULE in a BOTTLE

NDC: 50090-3788-1 10 CAPSULE in a BOTTLE

Description

Diphenhydramine HCl… 25 mg Diphenhydramine HCl… 50 mg

Questions?

Questions or comments? (800) 616-2471

Use

25 MG

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- runny nose
- sneezing
- itchy, watery eyes
- itchy throat and nose
Temporarily relieves these symptoms due to the common cold:
- runny nose
- sneezing

50 MG

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies and common cold
- sneezing
- runny nose
- itchy, watery eyes
- itchy throat and nose

Distributed By

MAJOR® PHARMACEUTICALS

17177 N Laurel Park Drive, Suite 233,

Livonia, MI 48152

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 Or Pharmacist

before use if you are taking sedatives or tranquilizers

If Pregnant Or Breast Feeding

ask a health professional before use.

Keep Out of Reach of Children

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

Ask A Doctor Before Use If You Have

25 MG

a breathing problem such as emphysema or chronic bronchitis
glaucoma
trouble urinating due to an enlarged prostate gland

50 MG

glaucoma
a breathing problem such as emphysema or chronic bronchitis
difficulty in urination due to enlargement of the prostate gland

Active Ingredient (in Each Banded Capsule)

Diphenhydramine HCl… 25 mg

Diphenhydramine HCl… 50 mg

Diphenhydramine Hydrochloride Capsule Banophen (diphenhydramine Hcl) Capsule

Structured Label Content

Warnings (WARNINGS)

Do not use

25 MG

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

50 MG

to make a child sleepy
with any other product containing diphenhydramine, including one applied topically

Purpose

Antihistamine

Directions

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

25 MG

adults and children 12 years of age and over	1 to 2 capsules
children 6 years to under 12 years of age	1 capsule
children under 6 years of age	do not use this product in children under 6 years of age

50 MG

adults and children 12 years of age and over	1 capsule
children 6 years to under 12 years of age	Ask a doctor, the proper dosage strength is not available in this package**

**Do not attempt to break capsules. The proper dosage strength and dosing information for children under 12 years of age is available on the 25 mg package.

Other Information

Store at 20°C – 25°C (68°F – 77°F); excursions permitted to 15° – 30°C (59° – 86°F) [See USP Controlled Room Temperature]
Protect from moisture
Contains lactose

Inactive Ingredients

D&C Red #28, FD&C Blue #1, FD&C Red #40, Gelatin, Lactose and Starch.

How Supplied (HOW SUPPLIED)

Product: 50090-3788

NDC: 50090-3788-0 8 CAPSULE in a BOTTLE

NDC: 50090-3788-1 10 CAPSULE in a BOTTLE

Questions?

Questions or comments? (800) 616-2471

Use

25 MG

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- runny nose
- sneezing
- itchy, watery eyes
- itchy throat and nose
Temporarily relieves these symptoms due to the common cold:
- runny nose
- sneezing

50 MG

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies and common cold
- sneezing
- runny nose
- itchy, watery eyes
- itchy throat and nose

Distributed By (Distributed by)

MAJOR® PHARMACEUTICALS

17177 N Laurel Park Drive, Suite 233,

Livonia, MI 48152

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 Or Pharmacist (Ask a doctor or pharmacist)

before use if you are taking sedatives or tranquilizers

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

ask a health professional before use.

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.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

25 MG

a breathing problem such as emphysema or chronic bronchitis
glaucoma
trouble urinating due to an enlarged prostate gland

50 MG

glaucoma
a breathing problem such as emphysema or chronic bronchitis
difficulty in urination due to enlargement of the prostate gland

Active Ingredient (in Each Banded Capsule) (Active Ingredient (in each banded capsule))

Diphenhydramine HCl… 25 mg

Diphenhydramine HCl… 50 mg

Diphenhydramine Hydrochloride Capsule Banophen (diphenhydramine Hcl) Capsule (DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE BANOPHEN (DIPHENHYDRAMINE HCL) CAPSULE)

Advanced Ingredient Data

[{"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": "ANHYDROUS LACTOSE", "unii": "3SY5LH9PMK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIPHENHYDRAMINE", "unii": "8GTS82S83M", "classCode": "ACTIB", "strengthNumerator": "25", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"Use": "25 MG Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itchy throat and nose Temporarily relieves these symptoms due to the common cold: runny nose sneezing 50 MG Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies and common cold sneezing runny nose itchy, watery eyes itchy throat and nose", "Purpose": "Antihistamine", "WARNINGS": "Do not use 25 MG to make a child sleepy with any other product containing diphenhydramine, even one used on skin 50 MG to make a child sleepy with any other product containing diphenhydramine, including one applied topically", "Directions": "Take every 4-6 hours Do not take more than 6 doses in 24 hours 25 MG adults and children 12 years of age and over 1 to 2 capsules children 6 years to under 12 years of age 1 capsule children under 6 years of age do not use this product in children under 6 years of age 50 MG adults and children 12 years of age and over 1 capsule children 6 years to under 12 years of age Ask a doctor, the proper dosage strength is not available in this package** **Do not attempt to break capsules. The proper dosage strength and dosing information for children under 12 years of age is available on the 25 mg package.", "Questions?": "Questions or comments? (800) 616-2471", "HOW SUPPLIED": "Product: 50090-3788 NDC: 50090-3788-0 8 CAPSULE in a BOTTLE NDC: 50090-3788-1 10 CAPSULE in a BOTTLE", "Distributed by": "MAJOR® PHARMACEUTICALS 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152", "Other Information": "Store at 20°C – 25°C (68°F – 77°F); excursions permitted to 15° – 30°C (59° – 86°F) [See USP Controlled Room Temperature] Protect from moisture Contains lactose", "Inactive Ingredients": "D&C Red #28, FD&C Blue #1, FD&C Red #40, Gelatin, Lactose and Starch.", "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 or pharmacist": "before use if you are taking sedatives or tranquilizers", "If pregnant or breast-feeding": "ask a health professional before use.", "KEEP OUT OF REACH OF CHILDREN": "In case of overdose, get medical help or contact a Poison Control Center right away.", "Ask a doctor before use if you have": "25 MG a breathing problem such as emphysema or chronic bronchitis glaucoma trouble urinating due to an enlarged prostate gland 50 MG glaucoma a breathing problem such as emphysema or chronic bronchitis difficulty in urination due to enlargement of the prostate gland", "Active Ingredient (in each banded capsule)": "Diphenhydramine HCl… 25 mg Diphenhydramine HCl… 50 mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:26.397967 · Updated: 2026-03-14T22:59:24.470306