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NDC 36800-0792-08 Allergy Relief 25 mg/1 Details

Allergy Relief 25 mg/1

Allergy Relief is a ORAL CAPSULE, LIQUID FILLED in the HUMAN OTC DRUG category. It is labeled and distributed by Topco Associates, LLC. 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: 36800-0792-08
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Diphenhydramine

Product Information

NDC	36800-0792
Product ID	36800-792_02f74e05-356e-4a42-9389-defd635009f5
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	Allergy Relief
Proprietary Name Suffix	n/a
Non-Proprietary Name	Diphenhydramine HCl
Product Type	HUMAN OTC DRUG
Dosage Form	CAPSULE, LIQUID FILLED
Route	ORAL
Active Ingredient Strength	25
Active Ingredient Units	mg/1
Substance Name	DIPHENHYDRAMINE HYDROCHLORIDE
Labeler Name	Topco Associates, LLC
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	n/a

Package

Package Images

NDC 36800-0792-08 (36800079208)

Pricing Information	N/A
NDC Package Code	36800-792-08
Billing NDC	36800079208
Package	2 BLISTER PACK in 1 CARTON (36800-792-08) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Start Date	2020-10-21
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 94b93b3a-593c-46a5-886d-f022b1df061b Details

Active ingredient (in each liquid-filled 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

glaucoma
a breathing problem such as emphysema or chronic bronchitis
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 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 and over	1 to 2 capsules
children 6 to under 12 years	1 capsule
children under 6 years	do not use

Other information

TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
protect from light, heat and moisture
see end flap for expiration date and lot number

Inactive ingredients

gelatin, glycerin, isopropyl alcohol, medium chain triglycerides, polyethylene glycol, povidone, purified water, sorbitol sorbitan solution, white ink

Questions or comments?

1-888-423-0139

Principal display panel

TopCare

Health®

NDC 36800-792-08

COMPARE TO BENADRYL®

DYE-FREE ALLERGY

ACTIVE INGREDIENT*

DYE-FREE

Allergy Relief

DIPHENHYDRAMINE HCl 25 mg - ANTIHISTAMINE

RELIEF OF:

• Sneezing

• Runny Nose

• Itchy, Watery Eyes

• Itchy Nose or Throat

Our Pharmacists Recommend

24 SOFTGELS**

** Liquid Filled Capsules

actual size

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

©TOPCO LNKA0920 QUESTIONS? 1-888-423-0139

[email protected] www.topcarebrand.com

PRODUCT OF DUBAI

PACKAGED AND QUALITY ASSURED IN THE USA

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

50844 ORG012072908

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS

OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR

SHOWS ANY SIGNS OF TAMPERING

TopCare 44-729

INGREDIENTS AND APPEARANCE

ALLERGY RELIEF

diphenhydramine hcl capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:36800-792
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
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
SORBITAN (UNII: 6O92ICV9RU)

Product Characteristics
Color	yellow (clear pale yellow)	Score	no score
Shape	OVAL	Size	16mm
Flavor		Imprint Code	729
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:36800-792-08	2 in 1 CARTON	10/21/2020	09/09/2023
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	10/21/2020	09/09/2023

Labeler - Topco Associates, LLC (006935977)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867837	pack(36800-792)

Revised: 11/2021

Document Id: 02f74e05-356e-4a42-9389-defd635009f5

Set id: 94b93b3a-593c-46a5-886d-f022b1df061b

Version: 3

Effective Time: 20211122