DIPHENHYDRAMINE HYDROCHLORIDE capsule

DIPHENHYDRAMINE HYDROCHLORIDE by

Drug Labeling and Warnings

DIPHENHYDRAMINE HYDROCHLORIDE by is a Otc medication manufactured, distributed, or labeled by CVS Pharmacy, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

• take every 4 to 6 hours 
• do not take more than 6 doses in 24 hours

• 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

• store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) 
• protect from moisture 
• see end flap for expiration date and lot number

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

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL

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

100 CAPSULES

INGREDIENTS AND APPEARANCE

DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hydrochloride capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69842-825
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	pink (Half pink and Half clear with white powder inside)	Score	no score
Shape	CAPSULE	Size	14mm
Flavor		Imprint Code	CPC;835
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69842-825-00	2 in 1 CARTON	06/20/2018
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 69842-825-22	4 in 1 CARTON	06/20/2018
2		12 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 69842-825-12	1 in 1 CARTON	06/20/2018
3		100 in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC: 69842-825-51	365 in 1 BOTTLE; Type 0: Not a Combination Product	06/20/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	06/20/2018

Labeler - CVS Pharmacy, Inc. (062312574)