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Name:Allergy
Manufacturer:Medicine Shoppe International Inc
Category:Over-the-counter (OTC) Marketed Drugs


Medicine Shoppe 44-190

ALLERGY - diphenhydramine hydrochloride capsule 
Medicine Shoppe International Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Medicine Shoppe 44-190

Active ingredient (in each banded capsule)

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

Uses

  • 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

Warnings

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.

Directions

  • 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 

Other information

  • store at controlled room temperature 15°-30°C (59°-86°F)

  • protect from moisture

  • see end flap for expiration date and lot number

Inactive ingredients

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

Questions or comments?

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

Product Packaging

Product Packaging


ALLERGY 
diphenhydramine hcl capsule
Product Information
Product Type HUMAN OTC DRUG 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) DIPHENHYDRAMINE HYDROCHLORIDE 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 PINK Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code 44;107
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49614-462-62 1 BLISTER PACK (1 BLISTER PACK) in 1 CARTON contains a BLISTER PACK
1 24 CAPSULE (24 CAPSULE) in 1 BLISTER PACK This package is contained within the CARTON (49614-462-62)
2 NDC:49614-462-78 1 BOTTLE, PLASTIC (1 BOTTLE) in 1 CARTON contains a BOTTLE, PLASTIC
2 100 CAPSULE (100 CAPSULE) in 1 BOTTLE, PLASTIC This package is contained within the CARTON (49614-462-78)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part336 03/15/1990

Labeler - Medicine Shoppe International Inc (071997654)

Revised: 04/2011 Medicine Shoppe International Inc



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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