ALLERGY RELIEF- diphenhydramine hcl capsule 
CVS Pharmacy

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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CVS 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
    • 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
  • difficulty in urination due to enlargement of the 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 beverages
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • use caution 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

  • take every 4 to 6 hours
  • do not take more than 6 doses in 24 hours
adults and children 12 years and over1 to 2 capsules
children 6 to under 12 years1 capsule
children under 6 yearsdo not use

Other information

  • protect from moisture 
  • TAMPER EVIDENT: PRODUCT SEALED IN PLASTIC STRIPS, CAPSULE BANDED FOR YOUR PROTECTION. DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN OR IF RED BAND AROUND CAPSULE IS BROKEN OR MISSING
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • 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 anhydrous, magnesium stearate, methylparaben, polysorbate 80, propylparaben, silicon dioxide

Questions or comments?

1-800-426-9391

Principal Display Panel

♥CVSHealth™

Compare to the active
ingredient in Benadryl®*

Capsules

NDC 59779-019-22

Allergy Relief

DIPHENHYDRAMINE
HYDROCHLORIDE, 25 mg
Antihistamine

Relief of:
• Sneezing
• Runny nose
• Itchy, watery eyes
• Itchy throat

48 CAPSULES

Actual Size

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.

*This product is not manufactured or distributed by
Johnson & Johnson Corporation, owner of the registered
trademark Benadryl®.
50844              REV1016A19022

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2017 CVS/pharmacy
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PLEASE RECYCLE

CVS Health 44-190

CVS Health 44-190

ALLERGY RELIEF 
diphenhydramine hcl capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-019
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)  
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Product Characteristics
Colorpink, whiteScoreno score
ShapeCAPSULESize14mm
FlavorImprint Code 44;107
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-019-224 in 1 CARTON03/15/199006/09/2023
112 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:59779-019-002 in 1 CARTON03/15/199001/04/2021
212 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:59779-019-236 in 1 CARTON03/15/199002/22/2018
312 in 1 BLISTER PACK; Type 0: Not a Combination Product
4NDC:59779-019-121 in 1 CARTON03/15/199006/07/2022
4100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
5NDC:59779-019-51365 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/15/199006/07/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/15/199006/09/2023
Labeler - CVS Pharmacy (062312574)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464pack(59779-019)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837pack(59779-019)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.868734088manufacture(59779-019) , pack(59779-019)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305pack(59779-019)

Revised: 6/2023
Document Id: 986af430-4569-4fe2-9d27-582a10cb235c
Set id: eafd9823-c0ad-454a-b725-562d88ebec92
Version: 13
Effective Time: 20230609
 
CVS Pharmacy