DIPHENHYDRAMINE HCL- diphenhydramine hcl 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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5347-CVS

Drug Facts

Active Ingredient (in each mini-capsule)

Diphenhydramine HCl 25mg

Purpose

Nighttime sleep-aid

Uses

for relief of occasional sleeplessness

Do not use

  • for children under 12 years of age
  • 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 brochitis
  • 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

avoid alcoholic beverages

Stop use and ask a doctor if

sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness

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 Poison Control Center (1-800-222-1222) right away.

Directions

Other Information

citric acid, edible ink, FD&C blue #1, FD&C red #3, FD&C red #40, gelatin, lactose, polysorbate 80, potassium sorbate, starch, titanium dioxide

Question or comments?

1-800-231-4670

KEEP OUTER PACKAGE FOR COMPLETE PRODUCT INFORMATION

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING OR IF BLUE

BAND AROUND CAPSULE IS BROKEN OR MISSING

*This product is not manufactured or distributed by Chattem, Inc., owner of the trademarks Unisom® and SleepMinis™.

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

CVSHealth

Compare to the active ingredient in Unisom® SleepMinis™*

Nighttime Sleep-Aid

Diphenhydramine HCl, 25mg

Nighttime sleep-aid

Non-habit forming

60 Mini-Capsules

5347-60ct-label

DIPHENHYDRAMINE HCL 
diphenhydramine hcl capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-537
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
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
FD&C RED NO. 3 (UNII: PN2ZH5LOQY)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
GELATIN (UNII: 2G86QN327L)  
STARCH, CORN (UNII: O8232NY3SJ)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorblueScoreno score
ShapeCAPSULESize14mm
FlavorImprint Code 5347
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69842-537-111 in 1 CARTON06/22/2018
160 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:69842-537-51365 in 1 BOTTLE; Type 0: Not a Combination Product06/22/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33806/22/2018
Labeler - CVS Pharmacy, Inc. (062312574)

Revised: 4/2020
Document Id: 9090b252-88b4-8521-e053-2995a90a025e
Set id: 6dd802ec-fc26-3913-e053-2a91aa0ad05d
Version: 3
Effective Time: 20200402
 
CVS Pharmacy, Inc.