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

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.

Purpose

Antihistamine

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

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

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

Description

.

Drug Facts

.

Active Ingredient

(in each capsule)

Diphenhydramine HCl 25 mg

Indications & Usage

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

runny nose

itchy nose or throat

sneezing

itchy, watery eyes

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

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.

Purpose (PURPOSE)

Antihistamine

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

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

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

Drug Facts (DRUG FACTS)

.

Active Ingredient (ACTIVE INGREDIENT)

(in each capsule)

Diphenhydramine HCl 25 mg

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

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