Diphenhydramine

Drug Facts

Composition & Product

Active Ingredients

Diphenhydramine (25 mg)

Inactive Ingredients

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

Identifiers & Packaging

Pill Appearance

Imprint: AP;020 Shape: capsule Color: pink Size: 14 mm Score: 1

Marketing Status

OTC MONOGRAPH FINAL Active Since 2018-01-01

Medication Information

Purpose

Antihistamine

Description

.

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 tranquilizers

When using this product

you may get very drowsy

avoid alcoholic drinks

alcohol, sedatives & 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 and children 12 years and over: take 1 to 2 capsules every 4-6 hours; not more than 6 doses in 24 hours

children under 12 years: ask a doctor

Drug Facts

.

Active Ingredient

(in each capsule)

Diphenhydramine HCl 25 mg

Other Information

store at 15-30 °C (59-86 °F)

protect from moisture

For 1000 Count: This is a bulk package. Dispense contents in a tight, light-resistant container with a child-resistant closure as defined in the USP

Indications & Usage

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

runny nose

itchy nose or throat

sneezing

itchy, watery eyes

Inactive Ingredients

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

Questions Or Comments

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

Distributed by: Qualitest Pharmaceuticals, Inc.

Dosage & Administration

adults and children 12 years and over: take 1 to 2 capsules every 4-6 hours; not more than 6 doses in 24 hours

children under 12 years: ask a doctor

Keep Out of Reach of Children.

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

Package Label.principal Display Panel

Structured Label Content

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 tranquilizers

When using this product

you may get very drowsy

avoid alcoholic drinks

alcohol, sedatives & 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 and children 12 years and over: take 1 to 2 capsules every 4-6 hours; not more than 6 doses in 24 hours

children under 12 years: ask a doctor

Drug Facts (DRUG FACTS)

.

Active Ingredient (ACTIVE INGREDIENT)

(in each capsule)

Diphenhydramine HCl 25 mg

Other Information (OTHER INFORMATION)

store at 15-30 °C (59-86 °F)

protect from moisture

For 1000 Count: This is a bulk package. Dispense contents in a tight, light-resistant container with a child-resistant closure as defined in the USP

Indications & Usage (INDICATIONS & USAGE)

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

runny nose

itchy nose or throat

sneezing

itchy, watery eyes

Inactive Ingredients (INACTIVE INGREDIENTS)

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

Questions Or Comments (QUESTIONS OR COMMENTS)

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

Distributed by: Qualitest Pharmaceuticals, Inc.

Dosage & Administration (DOSAGE & ADMINISTRATION)

adults and children 12 years and over: take 1 to 2 capsules every 4-6 hours; not more than 6 doses in 24 hours

children under 12 years: ask a doctor

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.

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"PURPOSE": "Antihistamine", "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 tranquilizers When using this product you may get very drowsy avoid alcoholic drinks alcohol, sedatives & 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 and children 12 years and over: take 1 to 2 capsules every 4-6 hours; not more than 6 doses in 24 hours children under 12 years: ask a doctor", "DRUG FACTS": ".", "ACTIVE INGREDIENT": "(in each capsule) Diphenhydramine HCl 25 mg", "OTHER INFORMATION": "store at 15-30 °C (59-86 °F) protect from moisture For 1000 Count: This is a bulk package. Dispense contents in a tight, light-resistant container with a child-resistant closure as defined in the USP", "INDICATIONS & USAGE": "temporarily relieves these symptoms of hay fever or other upper respiratory allergies: runny nose itchy nose or throat sneezing itchy, watery eyes", "INACTIVE INGREDIENTS": "benzyl alcohol, butylparaben, D&C red# 28, edible black ink, FD&C bule #1, FD&C red# 40, gelatin, lactose, magnesium stearate, methylparaben, polysorbate 80, propylparaben, sodium laurel sulfate", "QUESTIONS OR COMMENTS": "TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP OR BAND AROUND ANY CAPSULE IS MISSING OR DAMAGED Distributed by: Qualitest Pharmaceuticals, Inc.", "DOSAGE & ADMINISTRATION": "adults and children 12 years and over: take 1 to 2 capsules every 4-6 hours; not more than 6 doses in 24 hours children under 12 years: ask a doctor", "KEEP OUT OF REACH OF CHILDREN.": "In case of overdose, get medical help or contact a Poison Control Center right away."}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information