Diphenhydramine description, usages, side effects, indications, overdosage, supplying and lots more!

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Diphenhydramine

H.J. Harkins Company, Inc.
H.J. Harkins Company, Inc.

Diphenhydramine Hydrochloride Capsules


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient

Diphenhydramine Hydrochloride 50mg

Purpose

Antihistamine

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.

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.

Ask a doctor or pharamcist before use if you are

taking tranquilizers or sedatives.

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.

Pregnancy/breast-feeding warning

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.

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.

Diphenhydramine Other information

Store at controlled room temperature 59-86 degrees F.

Inactive ingredients

Lactose, starch, gelatin with bisulfites and artificial colors.

Questions?

Adverse drug event call: (800) 616-2471

Repacked by:

H.J. Harkins Company, Inc.

Grover Beach, CA 93433

Label

Diphenhydramine

Diphenhydramine

Diphenhydramine Hydrochloride CAPSULE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:52959-053(NDC:0904-5307)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE 50 mg

Inactive Ingredients

Ingredient Name Strength
GELATIN
LACTOSE
CROSCARMELLOSE SODIUM
SILICON DIOXIDE
FD&C RED NO. 40
MAGNESIUM STEARATE

Product Characteristics

Color Size Imprint Code Shape
pink 4 mm cpc;836 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:52959-053-06 06 in 1 BOTTLE
2 NDC:52959-053-12 12 in 1 BOTTLE
3 NDC:52959-053-15 15 in 1 BOTTLE
4 NDC:52959-053-20 20 in 1 BOTTLE
5 NDC:52959-053-10 10 in 1 BOTTLE
6 NDC:52959-053-30 30 in 1 BOTTLE
7 NDC:52959-053-52 52 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part348 2011-08-17


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Be sure to consult your doctor before taking any medication!
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