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NDC 69842-0825-12 DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 Details

DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1

DIPHENHYDRAMINE HYDROCHLORIDE is a ORAL CAPSULE in the HUMAN OTC DRUG category. It is labeled and distributed by CVS Pharmacy, Inc.. The primary component is DIPHENHYDRAMINE HYDROCHLORIDE.

MedlinePlus Drug Summary

Diphenhydramine is used to relieve red, irritated, itchy, watery eyes; sneezing; and runny nose caused by hay fever, allergies, or the common cold. Diphenhydramine is also used to relieve cough caused by minor throat or airway irritation. Diphenhydramine is also used to prevent and treat motion sickness, and to treat insomnia (difficulty falling asleep or staying asleep). Diphenhydramine is also used to control abnormal movements in people who have early stage parkinsonian syndrome (a disorder of the nervous system that causes difficulties with movement, muscle control, and balance) or who are experiencing movement problems as a side effect of a medication. Diphenhydramine will relieve the symptoms of these conditions but will not treat the cause of the symptoms or speed recovery. Diphenhydramine should not be used to cause sleepiness in children. Diphenhydramine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.

Related Packages: 69842-0825-12
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Diphenhydramine

Product Information

NDC	69842-0825
Product ID	69842-825_a615a8dd-50bc-1a0b-e053-2995a90a28a6
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	DIPHENHYDRAMINE HYDROCHLORIDE
Proprietary Name Suffix	n/a
Non-Proprietary Name	DIPHENHYDRAMINE HYDROCHLORIDE
Product Type	HUMAN OTC DRUG
Dosage Form	CAPSULE
Route	ORAL
Active Ingredient Strength	25
Active Ingredient Units	mg/1
Substance Name	DIPHENHYDRAMINE HYDROCHLORIDE
Labeler Name	CVS Pharmacy, Inc.
Pharmaceutical Class	Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part341
Listing Certified Through	2024-12-31

Package

Package Images

NDC 69842-0825-12 (69842082512)

Pricing Information	N/A
NDC Package Code	69842-825-12
Billing NDC	69842082512
Package	1 BOTTLE in 1 CARTON (69842-825-12) / 100 CAPSULE in 1 BOTTLE
Marketing Start Date	2018-06-20
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 6dfbb8ba-0cdb-57a2-e053-2991aa0a54e0 Details

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

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

365 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

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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	06/20/2018

Labeler - CVS Pharmacy, Inc. (062312574)

Revised: 5/2020

Document Id: a615a8dd-50bc-1a0b-e053-2995a90a28a6

Set id: 6dfbb8ba-0cdb-57a2-e053-2991aa0a54e0

Version: 3

Effective Time: 20200520