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NDC 70677-0144-01 children allergy relief dye free cherry 12.5 mg/5mL Details

children allergy relief dye free cherry 12.5 mg/5mL

children allergy relief dye free cherry is a ORAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Strategic Sourcing Services 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: 70677-0144-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Diphenhydramine

Product Information

NDC	70677-0144
Product ID	70677-0144_fa1a53b5-1258-41c4-8662-b8e6d3d57ea8
Associated GPIs
GCN Sequence Number	016675
GCN Sequence Number Description	diphenhydramine HCl LIQUID 12.5MG/5ML ORAL
HIC3	Z2P
HIC3 Description	ANTIHISTAMINES - 1ST GENERATION
GCN	48831
HICL Sequence Number	004480
HICL Sequence Number Description	DIPHENHYDRAMINE HCL
Brand/Generic	Generic
Proprietary Name	children allergy relief dye free cherry
Proprietary Name Suffix	n/a
Non-Proprietary Name	Diphenhydramine HCl
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION
Route	ORAL
Active Ingredient Strength	12.5
Active Ingredient Units	mg/5mL
Substance Name	DIPHENHYDRAMINE HYDROCHLORIDE
Labeler Name	Strategic Sourcing Services 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	2024-12-31

Package

Package Images

NDC 70677-0144-01 (70677014401)

Pricing Information
NDC Package Code	70677-0144-1
Billing NDC	70677014401
Package	1 BOTTLE in 1 CARTON (70677-0144-1) / 118 mL in 1 BOTTLE
Marketing Start Date	2022-05-16
NDC Exclude Flag	N
Price Per Unit	0.016
Pricing Unit	ML
Effective Date	2024-02-21
NDC Description	SM CHILD ALLERGY 12.5 MG/5 ML
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	1, 5
Classification for Rate Setting	G
As of Date	2024-02-21

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 c045360e-f788-4746-af8b-60e42d88d752 Details

ACTIVE INGREDIENT(in each 5 mL)

Diphenhydramine HCl 12.5 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

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 THE CHILD HAS

glaucoma
a breathing problem such as chronic bronchitis

ASK A DOCTOR OR PHARMACIST BEFORE USE IF THE CHILD IS

taking sedatives or tranquilizers

WHEN USING THIS PRODUCT

sedatives and tranquilizers may increase drowsiness
marked drowsiness may occur
excitability may occur, especially in children

KEEP OUT OF REACH OF CHILDREN

In case of overdose, get medical help or contact a poison control center right away

(1-800-222-1222).

DIRECTIONS

find right dose on chart below

mL=milliliter
measure only with dosing cup provided
do not use dosing cup with other products
take every 4 to 6 hours, or as directed by a doctor
do not take more than 6 doses in 24 hours

AGE(yr)	DOSE(mL)
children under 2 years	do not use
children 2 to 5 years	do not use unless directed by a doctor
children 6 to 11 years	5 mL to 10 mL

OTHER INFORMATION

each 5 mL contains: sodium 5 mg
dosing cup provided
store between 20 - 25oC (68o- 77oF)

INACTIVE INGREDIENTS

carboxymethylcellulose sodium, citric acid, flavors, glycerin, purified water, saccharin sodium, sodium benzoate, sorbitol.

QUESTIONS OR COMMENTS?

Call 833-358-6431 Monday to Friday 9:00 am to 7:00 pm EST

PRINCIPAL DISPLAY PANEL

SUNMARK®

COMPARE TO CHILDREN'S BENADRYL®

ORAL SOLUTION ACTIVE INGREDIENT*

NDC 70677-0144-1

children's allergy relief dye-free

Relieves: Sneezing,

Runny Nose,

Itchy, Watery Eyes

& Itching of the Nose or Throat

4-6 Hours/Dose

ANTIHISTAMINE

DIPHENHYDRAMINE HCl 12.5 MG/5 mL ORAL SOLUTION

CHERRY FLAVOR

4 FL OZ(118 mL)

INGREDIENTS AND APPEARANCE

CHILDREN ALLERGY RELIEF DYE FREE CHERRY

diphenhydramine hcl solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70677-0144
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
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
glycerin (UNII: PDC6A3C0OX)
water (UNII: 059QF0KO0R)
sodium benzoate (UNII: OJ245FE5EU)
sorbitol (UNII: 506T60A25R)
SACCHARIN SODIUM ANHYDROUS (UNII: I4807BK602)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70677-0144-1	1 in 1 CARTON	05/16/2022
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:70677-0144-2	1 in 1 CARTON	05/16/2022
2		236 mL in 1 BOTTLE; 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	04/22/2022

Labeler - Strategic Sourcing Services LLC (116956644)

Revised: 5/2022

Document Id: fa1a53b5-1258-41c4-8662-b8e6d3d57ea8

Set id: c045360e-f788-4746-af8b-60e42d88d752

Version: 4

Effective Time: 20220516