Diphenhydramine Hydrochloride Capsules

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

Shape: capsule Color: pink Size: 4 mm Score: 1

Marketing Status

OTC MONOGRAPH FINAL Active Since 2010-08-30

Medication Information

Purpose

Antihistamine

Description

Diphenhydramine Hydrochloride 25 mg

Uses

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies and common cold, sneezing, runny nose, itchy, watery eyes, itchy throat and nose.

Warnings

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.

Directions

Adults and children 12 years and over: take 25 to 50 mg (1 to 2 capsule) every 4 to 6 hours; not more than 12 capsules in 24 hours.

Children 6 years to 12 years of age: take 25 mg (1 capsule) every 4 to 6 hours; not more than 6 capsules in 24 hours.

Children under 6 years of age: ask a doctor

Package Label

25 mg Capsules

Other Information

Store at controlled room temperature 59-86 degrees F.

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?

Distributed by:

Qualitest Pharmaceuticals, Inc.

130 Vintage Drive

Huntsville, AL 35811

Repackaged by:

Contract Pharmacy Services-PA

125 Titus Ave Suite 200

Warrington, PA 18976 USA

Original--08/2010--NJW

When Using This Product

you may get 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. Do not use any other products containing diphenhydramine.

If Pregnant Or Breast Feeding,

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. (1-800-222-1222

Active Ingredient (in Each Capsule)

Diphenhydramine Hydrochloride 25 mg

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.

Ask A Doctor Or Pharmacist Before Use If You Are

taking taking tranquilizers or sedative.

Structured Label Content

Uses (USES)

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies and common cold, sneezing, runny nose, itchy, watery eyes, itchy throat and nose.

Purpose (PURPOSE)

Antihistamine

Warnings (WARNINGS)

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.

Directions (DIRECTIONS)

Adults and children 12 years and over: take 25 to 50 mg (1 to 2 capsule) every 4 to 6 hours; not more than 12 capsules in 24 hours.

Children 6 years to 12 years of age: take 25 mg (1 capsule) every 4 to 6 hours; not more than 6 capsules in 24 hours.

Children under 6 years of age: ask a doctor

Package Label

25 mg Capsules

Other Information (OTHER INFORMATION)

Store at controlled room temperature 59-86 degrees F.

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?)

Distributed by:

Qualitest Pharmaceuticals, Inc.

130 Vintage Drive

Huntsville, AL 35811

Repackaged by:

Contract Pharmacy Services-PA

125 Titus Ave Suite 200

Warrington, PA 18976 USA

Original--08/2010--NJW

When Using This Product (When using this product)

you may get 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. Do not use any other products containing diphenhydramine.

If Pregnant Or Breast Feeding, (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. (1-800-222-1222

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

Diphenhydramine Hydrochloride 25 mg

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.

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking taking tranquilizers or sedative.

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 and common cold, sneezing, runny nose, itchy, watery eyes, itchy throat and nose.", "PURPOSE": "Antihistamine", "WARNINGS": "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.", "DIRECTIONS": "Adults and children 12 years and over: take 25 to 50 mg (1 to 2 capsule) every 4 to 6 hours; not more than 12 capsules in 24 hours. Children 6 years to 12 years of age: take 25 mg (1 capsule) every 4 to 6 hours; not more than 6 capsules in 24 hours. Children under 6 years of age: ask a doctor", "Package Label": "25 mg Capsules", "OTHER INFORMATION": "Store at controlled room temperature 59-86 degrees F.", "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?": "Distributed by: Qualitest Pharmaceuticals, Inc. 130 Vintage Drive Huntsville, AL 35811 Repackaged by: Contract Pharmacy Services-PA 125 Titus Ave Suite 200 Warrington, PA 18976 USA Original--08/2010--NJW", "When using this product": "you may get 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. Do not use any other products containing diphenhydramine.", "If pregnant or breast-feeding,": "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. (1-800-222-1222", "ACTIVE INGREDIENT (IN EACH CAPSULE)": "Diphenhydramine Hydrochloride 25 mg", "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.", "Ask a doctor or pharmacist before use if you are": "taking taking tranquilizers or sedative."}

Diphenhydramine Hydrochloride Capsules

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information