Diphenhydramine Hydrochloride Capsules, Usp 50 Mg

Drug Facts

Composition & Product

Active Ingredients

Diphenhydramine (50 mg)

Inactive Ingredients

Benzyl Alcohol Butylparaben D&c Red No. 28 Fd&c Blue No. 1 Fd&c Red No. 40 Gelatin Lactose Magnesium Stearate Methylparaben Polysorbate 80 Propylparaben Sodium Lauryl Sulfate

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH FINAL Active Since 2016-11-22

Medication Information

Purpose

Antihistamine

Description

Diphenhydramine HCl 50 mg

Uses

temporarily relieves these symptoms of hay fever or other upper respiratory allergies:

runny nose
sneezing
itchy nose or throat
itchy, watery eyes

Warnings

Do not use with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have

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

Ask a doctor or pharmacist before use if you are taking sedatives or tranqulizers

When using this product

you may get very drowsy
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

If pregnant or breast-feeding, ask a health professional before use.

Directions

adults & children 12 years and over: take 1 capsule every 4-6 hours; not more than 6 does in 24 hours
children under 12 years: ask a doctor

Other Information

store at 15°-30°C (59°-86°F)
protect from moisture
This is a bulk package. Dispense contents in a tight, light-resistant container with a child-resistant closure as defined in the USP

Inactive Ingredients

benzyl alcohol, butylparaben, D&C red #28, edible black ink, FD&C blue #1, FD&C red #40, gelatin, lactose, magnesium stearate, methylparaben, polysorbate 80, propylparaben, sodium lauryl sulfate

Questions Or Comments?

call 888-374-279 1, 8:30 am - 4:30 pm ET, Monday - Friday

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFTEY SEAL UNDER CAP OR BAND AROUND ANY CAPSULE IS MISSING OR DAMAGED

Distributed by:

Epic Pharma, LLC

Laurelton, NY

11413

Keep Out of the Reach of Children.

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

Active Ingredient (in Each Capsule)

Diphenhydramine HCl 50 mg

Package Label Principal Display Panel 50 Mg

Diphenhydramine HCl Capsules, USP 50 mg

ANTIHISTAMINE

1000 Capsules

THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

Structured Label Content

Uses (USES)

temporarily relieves these symptoms of hay fever or other upper respiratory allergies:

runny nose
sneezing
itchy nose or throat
itchy, watery eyes

Purpose (PURPOSE)

Antihistamine

Warnings (WARNINGS)

Do not use with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have

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

Ask a doctor or pharmacist before use if you are taking sedatives or tranqulizers

When using this product

you may get very drowsy
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

If pregnant or breast-feeding, ask a health professional before use.

Directions (DIRECTIONS)

adults & children 12 years and over: take 1 capsule every 4-6 hours; not more than 6 does in 24 hours
children under 12 years: ask a doctor

Other Information (OTHER INFORMATION)

store at 15°-30°C (59°-86°F)
protect from moisture
This is a bulk package. Dispense contents in a tight, light-resistant container with a child-resistant closure as defined in the USP

Inactive Ingredients (INACTIVE INGREDIENTS)

benzyl alcohol, butylparaben, D&C red #28, edible black ink, FD&C blue #1, FD&C red #40, gelatin, lactose, magnesium stearate, methylparaben, polysorbate 80, propylparaben, sodium lauryl sulfate

Questions Or Comments? (QUESTIONS OR COMMENTS?)

call 888-374-279 1, 8:30 am - 4:30 pm ET, Monday - Friday

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFTEY SEAL UNDER CAP OR BAND AROUND ANY CAPSULE IS MISSING OR DAMAGED

Distributed by:

Epic Pharma, LLC

Laurelton, NY

11413

Keep Out of the Reach of Children. (KEEP OUT OF THE REACH OF CHILDREN.)

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

Active Ingredient (in Each Capsule) (ACTIVE INGREDIENT (IN EACH CAPSULE))

Diphenhydramine HCl 50 mg

Package Label Principal Display Panel 50 Mg (PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 50 MG)

Diphenhydramine HCl Capsules, USP 50 mg

ANTIHISTAMINE

1000 Capsules

THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

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Diphenhydramine Hydrochloride Capsules, Usp 50 Mg

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information