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

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, or as directed by a doctor

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

INACTIVE INGREDIENT

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

QUESTIONS

Questions or comments? 1-800-231-4670

SPL UNCLASSIFIED SECTION

*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

PRINCIPAL DISPLAY PANEL

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: 51316-835
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
MAGNESIUM STEARATE (UNII: 70097M6I30)
STARCH, CORN (UNII: O8232NY3SJ)
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)

Product Characteristics
Color	pink (half pink and half clear with white powder inside and sealed with red band)	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: 51316-835-01	1 in 1 CARTON	12/01/2022
1		100 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 51316-835-07	365 in 1 BOTTLE; Type 0: Not a Combination Product	11/23/2022
3	NDC: 51316-835-03	4 in 1 CARTON	12/01/2022
3		12 in 1 BLISTER PACK; Type 0: Not a Combination Product
4	NDC: 51316-835-08	2 in 1 CARTON	11/16/2022
4		12 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	11/16/2022

Labeler - CVS Pharmacy, Inc (062312574)