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NDC 42507-0483-24 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 Hy-Vee. 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: 42507-0483-24
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Diphenhydramine

Product Information

NDC	42507-0483
Product ID	42507-483_b34fb419-cf96-4ac3-9947-cf8e0e221ff5
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	Hy-Vee
Pharmaceutical Class	Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part336
Listing Certified Through	n/a

Package

Package Images

NDC 42507-0483-24 (42507048324)

Pricing Information	N/A
NDC Package Code	42507-483-24
Billing NDC	42507048324
Package	24 BLISTER PACK in 1 CARTON (42507-483-24) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Start Date	2015-11-30
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 9fb76668-59b5-4c57-b1ba-b544be83a016 Details

Active ingredient (in each capsule)

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

Uses

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

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
trouble urinating due to an enlarged prostate gland
a breathing problem such as emphysema or chronic bronchitis

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 right away.

Directions

take every 4 to 6 hours
do not take more than 6 doses in 24 hours
swallow whole; do not crush, chew or dissolve

adults and children 12 years of age and over	take 1 to 2 capsules
children 6 to under 12 years of age	take 1 capsule
children under 6 years of age	do not use

Other information

store between 15-30ºC (59-86ºF)
protect from light, heat, and humidity

Inactive ingredients

edible dye free ink, gelatin, glycerin, polyethylene glycol, purified water, sorbitol-sorbitan solution

Questions or comments?

Call toll free 1-800-289-8343 Monday-Friday 9AM-4PM CST

Principal Display Panel

*COMPARE TO the active ingredient of Benadryl® LIQUI-GELS®

Allergy Relief

Diphenhydramine HCI, 25 mg Antihistamine

Dye Free

Relief from:

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Nose or Throat

Softgels**

(**Liquid-filled capsules)

*This product is not manufacturedor distributed by McNeil Consumer Healthcare, distributorof Benadryl®, or Catalent Pharma Solutions,Inc., owner of the registered trademark LIQUI-GELS®.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

DISTRIBUTED BY HY-VEE, INC.

5820 WESTOWN PARKWAY

WEST DES MOINES, IA 50266

www.hy-vee.com

Product Label

Hy-Vee Allergy Softgels

INGREDIENTS AND APPEARANCE

ALLERGY RELIEF

diphenhydramine hcl capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:42507-483
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)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
SORBITAN (UNII: 6O92ICV9RU)

Product Characteristics
Color	white	Score	no score
Shape	CAPSULE	Size	15mm
Flavor		Imprint Code	A33;SCU
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:42507-483-24	24 in 1 CARTON	11/30/2015	12/31/2023
1		1 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	part336	11/30/2015	12/31/2023

Labeler - Hy-Vee (006925671)

Revised: 10/2021

Document Id: b34fb419-cf96-4ac3-9947-cf8e0e221ff5

Set id: 9fb76668-59b5-4c57-b1ba-b544be83a016

Version: 5

Effective Time: 20211014