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

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Diphenhydramine

AAA Pharmaceutical, Inc.

Diphenhydramine Capsules


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient (in each capsule)

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

Diphenhydramine 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

Warnings

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

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

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

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

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.

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 mg12.5 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

Diphenhydramine 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

Distributed by:
AAA Pharmaceutical, Inc.
681 Main Street
Lumberton, NJ 08048

PRINCIPAL DISPLAY PANEL - 24 Capsule Blister Pack Carton

RESTORE u

NDC 57344-113-01

COMPARE TO THE ACTIVE
INGREDIENT IN BENADRYL®
ALLERGY KAPSEALS®

Allergy Relief

Antihistamine
Diphenhydramine HCl

Relieves: • Sneezing • Runny Nose
• Itchy, Watery Eyes • Itchy Throat

24 CAPSULES

Diphenhydramine

Diphenhydramine

DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:57344-113
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
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

Product Characteristics

Color Size Imprint Code Shape
WHITE 14 mm A;20 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 12 in 1 BLISTER PACK
2 12 in 1 BLISTER PACK
3 100 in 1 BOTTLE, PLASTIC
4 NDC:57344-113-03 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2012-12-22


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Be sure to consult your doctor before taking any medication!
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