ALLERGY- diphenhydramine hcl 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.

----------

Medicine Shoppe 44-190-Delisted

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
    • 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

  • 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 over1 to 2 capsules
children 6 to under 12 years of age1 capsule
children under 6 years of agedo not use this product in children under 6 years of age


Other information

  • store at controlled room temperature 15º-30ºC (59º-86ºF)
  • 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

Principal Display Panel

The Medicine
Shoppe®

NDC 49614-462-78

MAY CAUSE DROWSINESS

ALLERGY
Antihistamine
Diphenhydramine HCl

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

COMPARE TO BENADRYL®
active ingredient*

100%
SATISFACTION
GUARANTEED

100 CAPSULES

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

*This product is not manufactured or distributed by
McNeil Consumer Healthcare, owner of the registered
trademark Benadryl®.
50844          REV0810F19012

Distributed by
Medicine Shoppe International, Inc.
Earth City, MO 63045
www.medicineshoppe.com
A Cardinal Health Company
CIN 2811792         1-800-325-1397

MEDICINE SHOPPE® GUARANTEE
IF YOU ARE NOT FULLY SATISFIED
WITH THIS PRODUCT, SIMPLY RETURN
THE UNUSED PORTION FOR REPLACEMENT
OR FULL REFUND OF PURCHASE PRICE.

Medicine Shoppe 44-190

Medicine Shoppe 44-190

ALLERGY 
diphenhydramine hcl capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49614-462
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
D&C RED NO. 28 (UNII: 767IP0Y5NH)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
STARCH, CORN (UNII: O8232NY3SJ)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Product Characteristics
ColorPINKScoreno score
ShapeCAPSULESize14mm
FlavorImprint Code 44;107
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49614-462-621 in 1 CARTON03/15/199008/27/2018
124 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:49614-462-781 in 1 CARTON03/15/199012/07/2020
2100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34103/15/199012/07/2020
Labeler - Medicine Shoppe International Inc (071997654)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(49614-462)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.868734088MANUFACTURE(49614-462) , PACK(49614-462)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837PACK(49614-462)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305PACK(49614-462)

Revised: 12/2017
Document Id: 19a7f748-d0e0-4898-bffc-d56af1f81794
Set id: 13d3808e-8342-4504-952c-9f0c3a329174
Version: 8
Effective Time: 20171207
 
Medicine Shoppe International Inc