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

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Diphenhydramine HCl

Cardinal Health

Diphenhydramine HCl 25 mg


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient

Diphenhydramine Hydrochloride 25 mg

Purpose

Antihistamine

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.

Diphenhydramine HCl Uses

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

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

Warnings

Ask a doctor before use if you have glaucoma, a breathing problem such as emphysema or chronic bronchitis or trouble urinating due to an enlarged prostate gland. This package is intended for institutional use only. Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Ask a doctor or pharmacist before use if you are taking tranquilizers or sedative. If pregnant or breast-feeding, ask a health professional before use.

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 under 12 years of age take 12.5 mg** to 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
**12.5 mg dosage strength is not available in this package. Do not attempt to break capsule.

Inactive ingredients

D&C Red #28, FD&C Blue #1, FD&C Red #40, Gelatin, Lactose and Starch

Storage

Store at 20-25 C (68-77 F); excursions permitted to 15-30 C (59-86 F). [See USP Controlled Room Temperature]. Protect from excessive moisture.

Distributed by

Major Pharmaceuticals

31778 Enterprise Drive

Livonia, MI 48150 USA

Questions? Adverse Drug

Event Call: (800) 616-2471

MFGD By Contract Pharm., NY 11788

Principal Display Panel

Diphenhydramine HCl

Capsules 25 mg

10 Capsules

Diphenhydramine HCl

Diphenhydramine HCl

Diphenhydramine HCl CAPSULE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:55154-0683(NDC:0904-5306)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE 25 mg

Inactive Ingredients

Ingredient Name Strength
D&C RED NO. 28
FD&C BLUE NO. 1
FD&C RED NO. 40
GELATIN
LACTOSE
STARCH, CORN

Product Characteristics

Color Size Imprint Code Shape
WHITE 6 mm CPC;835 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 1 in 1 BLISTER PACK
2 NDC:55154-0683-0 10 in 1 BAG

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2011-06-03


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Be sure to consult your doctor before taking any medication!
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