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

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DIPHENHYDRAMINE HYDROCHLORIDE

DIRECT RX

DIPHENHYDRAMINE HYDROCHLORIDE


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active Ingredient

Active Ingredient

(in each capsule)

Diphenhydramine HCl 50 mg

Purpose

Antihistamine

DIPHENHYDRAMINE HYDROCHLORIDE Uses

temporarily relieves these symptoms of hay fever or other upper respiratory allergies:

  • runny nose
  • itchy nose or throat
  • sneezing
  • itchy, watery eyes

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

  • you may get very drowsy
  • avoid alcoholic drink
  • salcohol, sedatives & tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

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

  • adults and children 12 years and over:take 1 to 2 capsules every 4-6 hours; not more than 6 doses in 24 hours
  • children under 12 years: ask a doctor

Other Information

  • store at 15-30 °C (59-86 °F)
  • protect from moisture
  • For 1000 Count: This is a bulk package. Dispense contents in a tight, light-resistant container with a child-resistant closure as defined in the USP

Inactive Ingredients

benzyl alcohol, butylparaben, D&C red# 28, edible black ink, FD&C bule #1, FD&C red# 40, gelatin, lactose, magnesium stearate, methylparaben, polysorbate 80, propylparaben, sodium laurel sulfate

Questions or Comments

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP OR BAND AROUND ANY CAPSULE IS MISSING OR DAMAGED

Distributed by: Qualitest Pharmaceuticals, Inc.

OTHER INFORMATION

  • store at 15-30 °C (59-86 °F)
  • protect from moisture
  • For 1000 Count: This is a bulk package. Dispense contents in a tight, light-resistant container with a child-resistant closure as defined in the USP

OTHER INFORMATION

benzyl alcohol, butylparaben, D&C red# 28, edible black ink, FD&C bule #1, FD&C red# 40, gelatin, lactose, magnesium stearate, methylparaben, polysorbate 80, propylparaben, sodium laurel sulfate

Questions or Comments

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP OR BAND AROUND ANY CAPSULE IS MISSING OR DAMAGED

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DIPHENHYDRAMINE HYDROCHLORIDE

DIPHENHYDRAMINE HYDROCHLORIDE

DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:61919-079(NDC:0603-3340)
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
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
pink 14 mm AP;021 capsule

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:61919-079-30 30 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2014-01-01


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Be sure to consult your doctor before taking any medication!
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