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NDC 76281-0313-26 Childrens Allergy Relief 12.5 mg/5mL Details

Childrens Allergy Relief 12.5 mg/5mL

Childrens Allergy Relief is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by AptaPharma 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: 76281-0313-26
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Diphenhydramine

Product Information

NDC	76281-0313
Product ID	76281-313_1ce498d7-46e2-47d7-8e49-cb708aa59767
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	Childrens Allergy Relief
Proprietary Name Suffix	n/a
Non-Proprietary Name	DIPHENHYDRAMINE HCl
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	ORAL
Active Ingredient Strength	12.5
Active Ingredient Units	mg/5mL
Substance Name	DIPHENHYDRAMINE HYDROCHLORIDE
Labeler Name	AptaPharma 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	2022-12-31

Package

Package Images

NDC 76281-0313-26 (76281031326)

Pricing Information	N/A
NDC Package Code	76281-313-26
Billing NDC	76281031326
Package	237 mL in 1 BOTTLE (76281-313-26)
Marketing Start Date	2018-08-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 3608d7ac-c056-4c85-8ebc-4f54c7369629 Details

SPL UNCLASSIFIED SECTION

Drug Facts

SPL UNCLASSIFIED SECTION

Active ingredient (in each 5 mL)

Diphenhydramine HCl 12.5 mg

SPL UNCLASSIFIED SECTION

Purpose

Diphenhydramine HCl ............................. Antihistamine

SPL UNCLASSIFIED SECTION

Uses

■ temporarily relieves these symptoms due to hay fever or

other respiratory allergies: • sneezing • itching of the nose or throat

• runny nose • itchy watery eyes ■ temporarily relieves these

symptoms due to the common cold: • sneezing • runny nose

SPL UNCLASSIFIED SECTION

Warnings

Do not use

• with any other product containing diphenhydramine, even one

used on skin

• to make a child sleepy

SPL UNCLASSIFIED SECTION

Ask a doctor before use if the child has

• glaucoma

• abreathing problem such as chronic bronchitis

SPL UNCLASSIFIED SECTION

Ask a doctor or pharmacist before use if the child is taking

sedatives or tranquilizers

SPL UNCLASSIFIED SECTION

When using this product

• marked drowsiness will occur

• excitability may occur, especially in children

• sedatives and tranquilizers may increase drowsiness

SPL UNCLASSIFIED SECTION

Keep out of reach of children. In case of overdose, get

medical help or contact a Poison Control Center right away.

SPL UNCLASSIFIED SECTION

Directions

if needed, take every 4-6 hours

do not take more than 6 doses in 24 hours

mL= millilite

Age Dose
children 6 to under 12 years of age	5 mL to 10 mL
children 4 to under 6 years of age	Do not use unless directed by a doctor
children under 4 years of age	Do not use

SPL UNCLASSIFIED SECTION

Other information

• each 5 mL contains: sodium 3 mg

• store at 20-25°C (68-77°F).

• dosage cup provided

SPL UNCLASSIFIED SECTION

Inactive ingredients

Anhydrous citric acid, flavor, purified water, sodium benzoate, sucrose

SPL UNCLASSIFIED SECTION

Questions? Call weekdays from 9:30 AM to 4:30 PM EST at 1-877-798-5944

Principal Display Panel

CVS

HealthTM

Compare to the active

ingredient in Children's

Benadryl® Allergy Liquid*

Children's

Allergy

Relief

LIQUID MEDICATION

Free of alcohol, dyes &

artificial sweeteners

DIPHENHYDRAMINE HCl

ORAL SOLUTION

Antihistamine

Relieves:

• Sneezing; Runny nose

• Itchy, watery eyes

• Itchy throat

Cherry Flavor

For Ages

6 to 12 Years

8 FL OZ (237 mL)

DO NOT USE IF IMPRINTED SHRINK BAND IS MISSING OR BROKEN

Failure to follow these warnings could result in serious consequences

*This product is not manufactured or distributed by McNeil

Consumer Healthcare, distributor of Children's Benadryl®

Allergy Liquid.

Lot:

Exp:

LR-112 #194380

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2018 CVS/pharmacy

CVS.com® 1-800-SHOP CVS

V-34801

√CVS Quality

Money Back Guarantee

Package Label

Children's Allergy Relief by CVS Pharmacy, Inc.

res

INGREDIENTS AND APPEARANCE

CHILDRENS ALLERGY RELIEF

diphenhydramine hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:76281-313
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	12.5 mg in 5 mL

Ingredient Name	Strength
Inactive Ingredients
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SUCROSE (UNII: C151H8M554)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:76281-313-26	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/01/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	08/01/2018

Labeler - AptaPharma Inc. (790523323)

Registrant - AptaPharma Inc. (790523323)

Name	Address	ID/FEI	Business Operations
Establishment
AptaPharma Inc.		790523323	manufacture(76281-313)

Revised: 10/2018

Document Id: 1ce498d7-46e2-47d7-8e49-cb708aa59767

Set id: 3608d7ac-c056-4c85-8ebc-4f54c7369629

Version: 1

Effective Time: 20181030

Search by Drug Name or NDC

NDC 76281-0313-26 Childrens Allergy Relief 12.5 mg/5mL Details

Childrens Allergy Relief 12.5 mg/5mL

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 76281-0313-26 (76281031326)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 3608d7ac-c056-4c85-8ebc-4f54c7369629 Details

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Principal Display Panel

INGREDIENTS AND APPEARANCE

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