Diphenhydramine Hydrochloride Capsules

Diphenhydramine Hydrochloride Capsules
SPL v4
SPL
SPL Set ID ea0c7005-3122-4ff4-8bc1-dda8116803c1
Route
ORAL
Published
Effective Date 2011-08-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (50 mg)
Inactive Ingredients
Gelatin Lactose Croscarmellose Sodium Silicon Dioxide Fd&c Red No. 40 Magnesium Stearate

Identifiers & Packaging

Pill Appearance
Imprint: cpc;836 Shape: capsule Color: pink Size: 4 mm Score: 1
Marketing Status
OTC MONOGRAPH FINAL Active Since 2011-08-17

Description

Diphenhydramine Hydrochloride 50mg

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

Diphenhydramine Hydrochloride 50mg

Use

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.

Section 51945-4

Label





Warning

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.

Questions?

Adverse drug event call: (800) 616-2471

Repacked by:

H.J. Harkins Company, Inc.

Grover Beach, CA 93433

Active Ingredient

Diphenhydramine Hydrochloride 50mg

Other Information

Store at controlled room temperature 59-86 degrees F.

Inactive Ingredients

Lactose, starch, gelatin with bisulfites and artificial colors.

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.

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.

Pregnancy/breast Feeding Warning

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

Ask A Doctor Or Pharamcist Before Use If You Are

taking tranquilizers or sedatives.


Structured Label Content

Use

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.

Section 51945-4 (51945-4)

Label





Purpose

Antihistamine

Warning

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.

Questions?

Adverse drug event call: (800) 616-2471

Repacked by:

H.J. Harkins Company, Inc.

Grover Beach, CA 93433

Active Ingredient (Active ingredient)

Diphenhydramine Hydrochloride 50mg

Other Information (Other information)

Store at controlled room temperature 59-86 degrees F.

Inactive Ingredients (Inactive ingredients)

Lactose, starch, gelatin with bisulfites and artificial colors.

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.

Keep Out of Reach of Children (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.

Pregnancy/breast Feeding Warning (Pregnancy/breast-feeding warning)

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

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

taking tranquilizers or sedatives.


Advanced Ingredient Data


Raw Label Data

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