ALLERGY- diphenhydramine hcl capsule 
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:
    • 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

  • 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 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 times in 24 hours 
 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

  • read the directions, warnings and accompanying label information before use
  • store at room temperature 15° to 30°C (59° to 86°F)
  • protect from light

Inactive ingredients

D&C red #28, FD&C blue #1, FD&C red #40, gelatin, lactose, starch

Questions or comments?

 Call toll free 1-888-423-0139

Principal Display Panel

MULTI-SYMPTOM

Allergy Capsules

DIPHENHYDRAMINE HCl,  25 mg

ANTIHISTAMINE

For Allergy Relief

•Sneezing  •Runny Nose

•Itchy, Watery Eyes  •Itchy Throat

COMPARE TO BENADRYL® active ingredient*

Each capsule individually banded for your protection

CAPSULES

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

TAMPER EVIDENT: 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.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

topcare@topco.com

Package Label

Diphenhydramine HCl 25 mg

Top Care Allergy Relief Capsules

ALLERGY 
diphenhydramine hcl capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-970
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
D&C RED NO. 28 (UNII: 767IP0Y5NH)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GELATIN (UNII: 2G86QN327L)  
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorPINK, WHITEScoreno score
ShapeCAPSULESize15mm
FlavorImprint Code CPC835
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-970-674 in 1 CARTON11/30/201312/31/2018
112 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:36800-970-363 in 1 CARTON11/30/201312/31/2018
212 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:36800-970-622 in 1 CARTON11/30/201312/31/2018
312 in 1 BLISTER PACK; Type 0: Not a Combination Product
4NDC:36800-970-781 in 1 BOX11/30/201312/31/2018
4100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33611/30/201312/31/2018
Labeler - TOP CARE (Topco Associates LLC) (006935977)

Revised: 12/2018
Document Id: ed8a589b-f13b-4aba-908b-5995df079762
Set id: 3a5e76c1-5564-4867-9548-e73114e91267
Version: 3
Effective Time: 20181227
 
TOP CARE (Topco Associates LLC)