ALLERGY RELIEF ANTIHISTAMINE- diphenhydramine hcl capsule, liquid filled 
TOP CARE (Topco Associates 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.

----------

Drug Facts

Active ingredient (in each capsule)

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

Uses

  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    • itchy, watery eyes
    • runny nose
    • sneezing
    • itching of the nose or throat
  • temporarily relieves these symptoms due to the common cold:
    • runny nose
    • sneezing 

Warnings

Do not use

  • with any other product containing diphenhydramine, even one used on skin
  • to make a child sleepy

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

  • 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
  • swallow whole; do not crush, chew or dissolve
adults and children 12 years of age and over take 1 to 2 capsules 
children 6 to under 12 years of age take 1 capsule
children under 6 years of age do not use

Other information

  • store at 59° to 77°F in a dry place. Protect from heat, humidity and light.

Inactive ingredients

edible dye free ink, gelatin, glycerin, polyethylene glycol, purified water, sorbitol-sorbitan solution

Questions or comments?

1-888-423-0139

Principal Display Panel

ANTIHISTAMINE

Allergy Relief

DIPHENHYDRAMINE HCl 25 mg

Relieves:

Sneezing                  Runny Nose

Itchy, Watery Eyes    Itchy Nose or Throat

COMPARE TO BENADRYL® LIQUI-GELS® active ingredient*

DYE-FREE

SOFTGELS**  25 mg Each

(**Liquid-filled capsules)

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Benadryl®, or Catalent Pharma Solutions, Inc., owner of the registered trademark LIQUI-GELS®.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

topcare@topco.com

Product of Canada

Product Label

Diphenhydramine HCL 25 mg

Top Care Allergy Relief Dye-Free Softgel

ALLERGY RELIEF  ANTIHISTAMINE
diphenhydramine hcl capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-720
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
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
SORBITAN (UNII: 6O92ICV9RU)  
Product Characteristics
ColorWHITE, YELLOWScoreno score
ShapeCAPSULESize15mm
FlavorImprint Code A33
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-720-242 in 1 CARTON05/30/201305/30/2020
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 FINALpart33605/30/201305/30/2020
Labeler - TOP CARE (Topco Associates LLC) (006935977)

Revised: 6/2019
Document Id: 96213cab-53fb-4e8d-a373-e5dbb1cb750b
Set id: 0e406d0b-8a92-4128-8556-f09695202028
Version: 2
Effective Time: 20190625
 
TOP CARE (Topco Associates LLC)