DIPHENHYDRAMINE HYDROCHLORIDE- diphenhydramine hydrochloride capsule 
CVS Pharmacy, 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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0835 - CVS

Drug Facts

Active ingredient (in each banded capsule)

Diphenhydramine HCI 25 mg.

Purpose

Antihistamine

Uses

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 (1-800-222-1222) right away.

Directions

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

Inactive ingredients

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

Questions or comments?

1-800-231-4670

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.

RETAIN CARTON FOR COMPLETE PRODUCT INFORMATION

*This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., owner of the registered trademark Benadryl®.

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2018 CVS/pharmacy

CVS.com® 1-800-SHOP CVS

V-34601

CVSHealth

Compare to the active ingredient in Benadryl®*

Allergy Relief

DIPHENHYDRAMINE HYDROCHLORIDE,

25 mg - Antihistamine

Relief of:

Sneezing, Runny nose,

Itchy, watery eyes, Itchy throat

365 CAPSULES

CVS Label

DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hydrochloride capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-825
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)  
GELATIN (UNII: 2G86QN327L)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
Colorpink (Half pink and Half clear with white powder inside) Scoreno score
ShapeCAPSULESize14mm
FlavorImprint Code CPC;835
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69842-825-002 in 1 CARTON06/20/2018
112 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:69842-825-224 in 1 CARTON06/20/2018
212 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:69842-825-121 in 1 CARTON06/20/2018
3100 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:69842-825-51365 in 1 BOTTLE; Type 0: Not a Combination Product06/20/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/20/2018
Labeler - CVS Pharmacy, Inc. (062312574)

Revised: 5/2020
Document Id: a615a8dd-50bc-1a0b-e053-2995a90a28a6
Set id: 6dfbb8ba-0cdb-57a2-e053-2991aa0a54e0
Version: 3
Effective Time: 20200520
 
CVS Pharmacy, Inc.