Winco 44-190

Winco 44-190

Drug Labeling and Warnings

Drug Details

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ALLERGY RELIEF COMPLETE- diphenhydramine hcl capsule 
WinCo Foods, LLC

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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Winco 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 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 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 25ºC (77ºF); excursions permitted between 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, polysorbate 80, propylparaben, silica gel

Questions?

Or to report a side effect call 800-824-1706 Monday - Friday 9am - 4pm MST 

Principal Display Panel

WinCo™
FOODS

COMPLETE
Allergy
Relief

DIPHENHYDRAMINE HCl 25 mg/
ANTIHISTAMINE

*Compare to the active ingredient
in BENADRYL® Allergy

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

24
Capsules 

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

DISTRIBUTED BY:
WINCO FOODS, LLC, BOISE, ID 83704

*This product is not manufactured or distributed by
MCNEIL CONSUMER HEALTHCARE, distributor of
BENADRYL® Allergy.

50844     ORG051219008     WF1409

100% SATISFACTION GUARANTEE
Comments & Questions? 800-824-1706

Winco 44-190

Winco 44-190

ALLERGY RELIEF  COMPLETE
diphenhydramine hcl capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 67091-201
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)  
STARCH, CORN (UNII: O8232NY3SJ)  
D&C RED NO. 28 (UNII: 767IP0Y5NH)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Product Characteristics
ColorPINK, WHITEScoreno score
ShapeCAPSULESize14mm
FlavorImprint Code 44;107
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 67091-201-242 in 1 CARTON03/15/1990
112 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34103/15/1990
Labeler - WinCo Foods, LLC (056098817)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(67091-201)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.868734088MANUFACTURE(67091-201) , PACK(67091-201)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305PACK(67091-201)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837PACK(67091-201)

Revised: 2/2019
 
WinCo Foods, LLC


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