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NDC 59779-0019-22 Allergy Relief 25 mg/1 Details

Allergy Relief 25 mg/1

Allergy Relief is a ORAL CAPSULE in the HUMAN OTC DRUG category. It is labeled and distributed by CVS Pharmacy. 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: 59779-0019-22
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Diphenhydramine

Product Information

NDC	59779-0019
Product ID	59779-019_03baa703-dbbf-4690-ab32-25910834d626
Associated GPIs	41200030100105
GCN Sequence Number	011582
GCN Sequence Number Description	diphenhydramine HCl CAPSULE 25 MG ORAL
HIC3	Z2P
HIC3 Description	ANTIHISTAMINES - 1ST GENERATION
GCN	45971
HICL Sequence Number	004480
HICL Sequence Number Description	DIPHENHYDRAMINE HCL
Brand/Generic	Generic
Proprietary Name	Allergy Relief
Proprietary Name Suffix	n/a
Non-Proprietary Name	Diphenhydramine HCl
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
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	2023-12-31

Package

Package Images

NDC 59779-0019-22 (59779001922)

Pricing Information	N/A
NDC Package Code	59779-019-22
Billing NDC	59779001922
Package	4 BLISTER PACK in 1 CARTON (59779-019-22) / 12 CAPSULE in 1 BLISTER PACK
Marketing Start Date	1990-03-15
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL eafd9823-c0ad-454a-b725-562d88ebec92 Details

Active ingredient (in each banded capsule)

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- runny nose
- itchy, watery eyes
- sneezing
- 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
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

marked drowsiness may occur
avoid alcoholic beverages
alcohol, sedatives, and tranquilizers may increase drowsiness
use caution 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 and over	1 to 2 capsules
children 6 to under 12 years	1 capsule
children under 6 years	do not use

Other information

protect from moisture
TAMPER EVIDENT: PRODUCT SEALED IN PLASTIC STRIPS, CAPSULE BANDED FOR YOUR PROTECTION. DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN OR IF RED BAND AROUND CAPSULE IS BROKEN OR MISSING
store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
see end flap for expiration date and lot number

Inactive ingredients

butylparaben, corn starch, D&C red #28, edible ink, FD&C blue #1, FD&C red #40, gelatin, lactose anhydrous, magnesium stearate, methylparaben, polysorbate 80, propylparaben, silicon dioxide

Questions or comments?

1-800-426-9391

Principal Display Panel

♥CVSHealth™

Compare to the active

ingredient in Benadryl®*

Capsules

NDC 59779-019-22

Allergy Relief

DIPHENHYDRAMINE

HYDROCHLORIDE, 25 mg

Antihistamine

Relief of:

• Sneezing

• Runny nose

• Itchy, watery eyes

• Itchy throat

48 CAPSULES

Actual Size

TAMPER EVIDENT: PRODUCT SEALED IN

PLASTIC STRIPS, CAPSULE BANDED FOR

YOUR PROTECTION. DO NOT USE IF

BLISTER UNIT IS TORN OR BROKEN OR IF

RED BAND AROUND CAPSULE IS BROKEN

OR MISSING.

*This product is not manufactured or distributed by

Johnson & Johnson Corporation, owner of the registered

trademark Benadryl®.

50844 REV1016A19022

V-18615

CVS® Quality

Money Back Guarantee

PLEASE RECYCLE

CVS Health 44-190

INGREDIENTS AND APPEARANCE

ALLERGY RELIEF

diphenhydramine hcl capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:59779-019
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
BUTYLPARABEN (UNII: 3QPI1U3FV8)
STARCH, CORN (UNII: O8232NY3SJ)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
MAGNESIUM STEARATE (UNII: 70097M6I30)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	pink, white	Score	no score
Shape	CAPSULE	Size	14mm
Flavor		Imprint Code	44;107
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:59779-019-22	4 in 1 CARTON	03/15/1990
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:59779-019-00	2 in 1 CARTON	03/15/1990	01/04/2021
2		12 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC:59779-019-23	6 in 1 CARTON	03/15/1990	02/22/2018
3		12 in 1 BLISTER PACK; Type 0: Not a Combination Product
4	NDC:59779-019-12	1 in 1 CARTON	03/15/1990	06/07/2022
4		100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
5	NDC:59779-019-51	365 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/15/1990	06/07/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	03/15/1990

Labeler - CVS Pharmacy (062312574)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	pack(59779-019)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867837	pack(59779-019)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		868734088	manufacture(59779-019) , pack(59779-019)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		967626305	pack(59779-019)

Revised: 6/2022

Document Id: 03baa703-dbbf-4690-ab32-25910834d626

Set id: eafd9823-c0ad-454a-b725-562d88ebec92

Version: 12

Effective Time: 20220607