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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0835K-CVS

Drug Facts

Active ingredient (in each banded capsule)

Diphenhydramine HCI 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

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

 take every 4 to 6 hours, or as directed by a doctor

 do not take more than 6 doses in 24 hours

adults and children 12 years of age and over1 to 2 capsules
children 6 to under 12 years of age1 capsule
children under 6 years of agedo not use this product in
children under 6 years of age

Other information

 store in a dry place at 15° – 30°C (59° – 86°F)
 protect from moisture

corn starch, D&C red #28, FD&C blue #1, FD&C red #40, gelatin, lactose monohydrate, magnesium stearate, sodium lauryl sulfate

Questions or comments? 1-800-231-4670

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

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2022 CVS/pharmacy
CVS.com® 1-800-SHOP CVS V-34601

Product of China. Manufactured and packaged in the U.S.A. using domestic and imported ingredients.

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

Compare to the active ingredient in Benadryl®*

Allergy Relief

DIPHENHYDRAMINE HYDROCHLORIDE
25 mg - Antihistamine

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

100 CAPSULES

CVS Label

DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hydrochloride capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51316-835
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
MAGNESIUM STEARATE (UNII: 70097M6I30)  
D&C RED NO. 28 (UNII: 767IP0Y5NH)  
GELATIN (UNII: 2G86QN327L)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
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 and sealed with red band) Scoreno score
ShapeCAPSULESize14mm
FlavorImprint Code CPC;835
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51316-835-011 in 1 CARTON12/01/2022
1100 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:51316-835-07365 in 1 BOTTLE; Type 0: Not a Combination Product11/23/2022
3NDC:51316-835-034 in 1 CARTON12/01/2022
312 in 1 BLISTER PACK; Type 0: Not a Combination Product
4NDC:51316-835-082 in 1 CARTON11/16/2022
412 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34111/16/2022
Labeler - CVS Pharmacy, Inc (062312574)

Revised: 2/2023
Document Id: f4468840-e17d-6888-e053-2995a90a04a0
Set id: f4468840-e17c-6888-e053-2995a90a04a0
Version: 1
Effective Time: 20230209
 
CVS Pharmacy, Inc