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NDC 70000-0085-01 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 Cardinal Health 110, LLC. DBA Leader. 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: 70000-0085-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Diphenhydramine

Product Information

NDC	70000-0085
Product ID	70000-0085_30bf0389-d657-4d38-91b5-8713dc9ac592
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, LIQUID FILLED
Route	ORAL
Active Ingredient Strength	25
Active Ingredient Units	mg/1
Substance Name	DIPHENHYDRAMINE HYDROCHLORIDE
Labeler Name	Cardinal Health 110, LLC. DBA Leader
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 70000-0085-01 (70000008501)

Pricing Information
NDC Package Code	70000-0085-1
Billing NDC	70000008501
Package	2 BLISTER PACK in 1 CARTON (70000-0085-1) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Start Date	2021-02-04
NDC Exclude Flag	N
Price Per Unit	0.03381
Pricing Unit	EA
Effective Date	2022-11-23
NDC Description	ALLERGY RELIEF 25 MG SOFTGEL
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	1
Classification for Rate Setting	G
As of Date	2022-11-23

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL 0f1fb455-23f8-485b-87a9-1327e2b8333f 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

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
excitability may occur, especially in children
use caution when driving a motor vehicle or operating machinery

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?

1-800-426-9391

Principal display panel

Leader

NDC 70000-0085-1

Dye-Free

Allergy Relief

Diphenhydramine HCl, 25 mg | Antihistamine

Allergy Relief for:

Sneezing, Runny Nose,

Itchy, Watery Eyes,

Itchy Throat

24 LIQUID GELS**

**Liquid-Filled Capsules

Actual Size

COMPARE TO

BENADRYL®

DYE-FREE ALLERGY

active ingredient*

100% Money Back Guarantee

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS

OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR

SHOWS ANY SIGNS OF TAMPERING

*This product is not manufactured or distributed by Johnson & Johnson

Corporation, owner of the registered trademark Benadryl® Dye-Free Allergy.

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com 1-800-200-6313

Product of Dubai

Packaged and Quality Assured in the USA

50844 ORG012072908

✔All LEADER™ Brand Products Have A

100% Money Back Guarantee

Return to place of purchase if not satisfied.

©2021 Cardinal Health. All Rights Reserved. CARDINAL HEALTH, the Cardinal Health

LOGO, LEADER, and the Leader LOGO are trademarks or registered trademarks of

Cardinal Health. All other marks are the property of their respective owners.

Leader 44-729

INGREDIENTS AND APPEARANCE

ALLERGY RELIEF

diphenhydramine hcl capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70000-0085
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, UNSPECIFIED (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE, UNSPECIFIED (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:70000-0085-1	2 in 1 CARTON	02/04/2021	12/01/2023
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	02/04/2021	12/01/2023

Labeler - Cardinal Health 110, LLC. DBA Leader (063997360)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867837	pack(70000-0085)

Revised: 7/2022

Document Id: 30bf0389-d657-4d38-91b5-8713dc9ac592

Set id: 0f1fb455-23f8-485b-87a9-1327e2b8333f

Version: 5

Effective Time: 20220713