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Allergy

Medicine Shoppe International Inc

Medicine Shoppe 44-190


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Diphenhydramine HCl 25 mg

Antihistamine

  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

  • runny nose

  • itchy, watery eyes

  • sneezing 

  • itching of the nose or throat

  • temporarily relieves these symptoms due to the common cold:

  • runny nose sneezing

Do not use

  • to make a child sleepy

  • with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have

  • a breathing problem such as emphysema or chronic bronchitis

  • glaucoma

  • trouble urinating due to an enlarged prostate gland

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

  • be careful when driving a motor vehicle or operating machinery

  • excitability may occur, especially in children

If pregnant of 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.

  • take every 4 to 6 hours

  • do not take more than 6 doses in 24 hours
    adults and children 12 years of age and over 1 to 2 capsules 
    children 6 to under 12 years of age 1 capsule 
    children under 6 years of age do not use this product in children under 6 years of age 
  • store at controlled room temperature 15°-30°C (59°-86°F)

  • protect from moisture

  • see end flap for expiration date and lot number

butylparaben, corn starch, D&C red #28, edible ink, FD&C blue #1, FD&C red #40, gelatin, lactose, magnesium stearate, methylparaben, propylparaben, polysorbate 80, silica gel

1-800-426-9391

Principal Display Panel

The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.

The Medicine Shoppe®

NDC 49614-462-62

MAY CAUSE DROWSINESS

ALLERGY

Diphenhydramine HCl

Antihistamine

• Sneezing

•Runny Nose

•Itchy, Watery Eyes

•Itchy Throat

COMPARE TO BENADRYL®

active ingredient*

24 CAPSULES

Each Capsule individually

banded for your protection

TAMPER EVIDENT: PRODUCT SEALED IN PLASTIC STRIPS, CAPSUL BANDED FOR YOUR PROTECTION. DO NOT USE IF BLISTER UNIT IS TORN OR BROKEN OR IF RED BAND AROUND CAPSULE IS BROKEN OR MISSING.

50844       REV0810F19008

Distributed by

Medicine Shoppe International, Inc.

Earth City, MO 63045

www.medicineshoppe.com

A Cardinal Health Company

CIN 1796648

1-800-325-1397

Allergy
Product Packaging

Allergy

Diphenhydramine HCl CAPSULE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:49614-462
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
BUTYLPARABEN
D&C RED NO. 28
FD&C BLUE NO. 1
D&C RED NO. 28
GELATIN
LACTOSE
MAGNESIUM STEARATE
METHYLPARABEN
PROPYLPARABEN
polysorbate 80

Product Characteristics

Color Size Imprint Code Shape
PINK 14 mm 44;107 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 24 in 1 BLISTER PACK
2 100 in 1 BOTTLE, PLASTIC
3 NDC:49614-462-78 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part336 1990-03-15


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Be sure to consult your doctor before taking any medication!
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