0836-major(100c/1000c)

SPL v105

SPL

SPL Set ID d0f4b9f4-e727-4d47-b156-7bcdcb1606da

Route

ORAL

Published

Effective Date 2011-12-30

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Diphenhydramine (50 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;836 Shape: capsule Color: pink Size: 14 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2009-11-02

Description

Diphenhydramine Hydrochloride 50 mg

Purpose

Antihistamine

How Supplied

NDC: 63629-9451-1: 30 CAPSULEs in a BOTTLE NDC: 63629-9451-2: 60 CAPSULEs in a BOTTLE

Medication Information

Warnings and Precautions

Do not use

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

Purpose

Antihistamine

How Supplied

NDC: 63629-9451-1: 30 CAPSULEs in a BOTTLE

NDC: 63629-9451-2: 60 CAPSULEs in a BOTTLE

Description

Diphenhydramine Hydrochloride 50 mg

Use

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

Section 42229-5

Distributed by: MAJOR® PHARMACEUTICALS

Indianapolis, IN 46268

(800) 616-2471

www.majorpharmaceuticals.com

Section 50570-1

Do not use

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

Section 51945-4

Directions

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

adults and children 12 years of age and over	Take 1 capsule (50 mg)
children 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?1-800-231-4670

Other Information

Store in a dry place at 15° – 30°C (59° – 86°F).
Do not use if either capsule band or imprinted safety seal under cap is broken or missing
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

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

Active Ingredient (in Each Banded Capsule)

Diphenhydramine Hydrochloride 50 mg

Structured Label Content

Use

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

Warnings and Precautions (34071-1)

Do not use

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

Section 42229-5 (42229-5)

Distributed by: MAJOR® PHARMACEUTICALS

Indianapolis, IN 46268

(800) 616-2471

www.majorpharmaceuticals.com

Section 50570-1 (50570-1)

Do not use

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

Section 51945-4 (51945-4)

Purpose

Antihistamine

Directions

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

adults and children 12 years of age and over	Take 1 capsule (50 mg)
children 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?1-800-231-4670

How Supplied (HOW SUPPLIED)

NDC: 63629-9451-1: 30 CAPSULEs in a BOTTLE

NDC: 63629-9451-2: 60 CAPSULEs in a BOTTLE

Other Information

Store in a dry place at 15° – 30°C (59° – 86°F).
Do not use if either capsule band or imprinted safety seal under cap is broken or missing
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 (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)

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

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

Diphenhydramine Hydrochloride 50 mg

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": "50", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"Use": "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", "34071-1": "Do not use to make a child sleepy with any other product containing diphenhydramine, even one used on skin", "42229-5": "Distributed by: MAJOR® PHARMACEUTICALS Indianapolis, IN 46268 (800) 616-2471 www.majorpharmaceuticals.com", "50570-1": "Do not use to make a child sleepy with any other product containing diphenhydramine, even one used on skin", "Purpose": "Antihistamine", "Directions": "Take every 4-6 hours Do not take more than 6 doses in 24 hours adults and children 12 years of age and over Take 1 capsule (50 mg) children 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?1-800-231-4670", "HOW SUPPLIED": "NDC: 63629-9451-1: 30 CAPSULEs in a BOTTLE NDC: 63629-9451-2: 60 CAPSULEs in a BOTTLE", "Other Information": "Store in a dry place at 15° – 30°C (59° – 86°F). Do not use if either capsule band or imprinted safety seal under cap is broken or missing 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": "glaucoma a breathing problem such as emphysema or chronic bronchitis trouble urinating due to an enlarged prostate gland", "Active Ingredient (in each banded capsule)": "Diphenhydramine Hydrochloride 50 mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:04.905324 · Updated: 2026-03-14T23:02:55.861635