1113-ddm-2021-1126

Drug Facts

Composition & Product

Active Ingredients

Diphenhydramine (25 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

Pill Appearance

Imprint: A;20 Shape: oval Color: pink Color: white Size: 14 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2007-11-30

Medication Information

Purpose

Antihistamine

Description

Drug Facts

Uses

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

Section 42229-5

Drug Facts

Section 50565-1

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

Section 50568-5

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

Section 50570-1

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

Section 53414-9

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

Directions

take every 4 to 6 hours
do not exceed 6 doses in 24 hours

adults and children 12 years of age and over	25 mg to 50 mg (1 to 2 capsules)
children 6 to under 12 years of age	12.5 mg 12.5 mg dosage strength is not available in this package. Do not attempt to break capsules. to 25 mg (1 capsule)
children under 6 years of age	ask a doctor

Other Information

store at room temperature 15°-30°C (59°-86°F)
protect from moisture
retain carton for complete product information

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

Principal Display Panel

DISCOUNT drug mart FOOD FAIR

†COMPARE TO THE ACTIVE INGREDIENT IN BENADRYL® ALLERGY KAPSEALS®

ALLERGY

Diphenhydramine HCl • Antihistamine

Temporary Relief of:

• Sneezing

• Runny Nose

• Itchy, Watery Eyes

• Itchy Throat

24 CAPSULES - 25 mg each

When Using This Product

marked drowsiness may occur
avoid alcoholic drinks
alcohol, sedatives, and tranquilizers may increase drowsiness
excitability may occur, especially in children
be careful when driving a motor vehicle or operating machinery

Active Ingredient (in Each Capsule)

Diphenhydramine HCl 25 mg

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

Structured Label Content

Uses

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

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Section 50568-5 (50568-5)

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

Section 50570-1 (50570-1)

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

Section 53414-9 (53414-9)

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

Purpose

Antihistamine

Directions

take every 4 to 6 hours
do not exceed 6 doses in 24 hours

adults and children 12 years of age and over	25 mg to 50 mg (1 to 2 capsules)
children 6 to under 12 years of age	12.5 mg 12.5 mg dosage strength is not available in this package. Do not attempt to break capsules. to 25 mg (1 capsule)
children under 6 years of age	ask a doctor

Other Information (Other information)

store at room temperature 15°-30°C (59°-86°F)
protect from moisture
retain carton for complete product information

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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

DISCOUNT drug mart FOOD FAIR

†COMPARE TO THE ACTIVE INGREDIENT IN BENADRYL® ALLERGY KAPSEALS®

ALLERGY

Diphenhydramine HCl • Antihistamine

Temporary Relief of:

• Sneezing

• Runny Nose

• Itchy, Watery Eyes

• Itchy Throat

24 CAPSULES - 25 mg each

When Using This Product (When using this product)

marked drowsiness may occur
avoid alcoholic drinks
alcohol, sedatives, and tranquilizers may increase drowsiness
excitability may occur, especially in children
be careful when driving a motor vehicle or operating machinery

Active Ingredient (in Each Capsule) (Active ingredient (in each capsule))

Diphenhydramine HCl 25 mg

Ask A Doctor Before Use If You Have (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

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat temporarily relieves these symptoms due to the common cold: runny nose sneezing", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "50568-5": "Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers", "50570-1": "Do not use with any other product containing diphenhydramine, even one used on skin", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "Purpose": "Antihistamine", "Directions": "take every 4 to 6 hours do not exceed 6 doses in 24 hours adults and children 12 years of age and over 25 mg to 50 mg (1 to 2 capsules) children 6 to under 12 years of age 12.5 mg 12.5 mg dosage strength is not available in this package. Do not attempt to break capsules. to 25 mg (1 capsule) children under 6 years of age ask a doctor", "Other information": "store at room temperature 15°-30°C (59°-86°F) protect from moisture retain carton for complete product information", "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", "PRINCIPAL DISPLAY PANEL": "DISCOUNT drug mart FOOD FAIR †COMPARE TO THE ACTIVE INGREDIENT IN BENADRYL® ALLERGY KAPSEALS® ALLERGY Diphenhydramine HCl • Antihistamine Temporary Relief of: • Sneezing • Runny Nose • Itchy, Watery Eyes • Itchy Throat 24 CAPSULES - 25 mg each", "When using this product": "marked drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness excitability may occur, especially in children be careful when driving a motor vehicle or operating machinery", "Active ingredient (in each capsule)": "Diphenhydramine HCl 25 mg", "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"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information