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NDC 70677-0101-01 Childrens Cold and Allergy Relief 2; 5 mg/10mL; mg/10mL Details

Childrens Cold and Allergy Relief 2; 5 mg/10mL; mg/10mL

Childrens Cold and Allergy Relief is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Strategic Sourcing Services LLC. The primary component is BROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE.

MedlinePlus Drug Summary

Brompheniramine relieves red, irritated, itchy, watery eyes; sneezing; and runny nose caused by allergies, hay fever, and the common cold. Brompheniramine helps control symptoms, but does not treat the cause of the symptoms or speed recovery. Brompheniramine should not be used to cause sleepiness in children. Brompheniramine 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: 70677-0101-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Brompheniramine

Phenylephrine is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Phenylephrine will relieve symptoms but will not treat the cause of the symptoms or speed recovery. Phenylephrine is in a class of medications called nasal decongestants. It works by reducing swelling of the blood vessels in the nasal passages.

Related Packages: 70677-0101-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Phenylephrine

Product Information

NDC	70677-0101
Product ID	70677-0101_1b678869-be0b-4cfc-a9bd-0e523472867e
Associated GPIs
GCN Sequence Number	061050
GCN Sequence Number Description	brompheniramine/phenylephrine SOLUTION 1-2.5 MG/5 ORAL
HIC3	Z2N
HIC3 Description	1ST GEN ANTIHISTAMINE AND DECONGESTANT COMBINATION
GCN	27207
HICL Sequence Number	000443
HICL Sequence Number Description	BROMPHENIRAMINE MALEATE/PHENYLEPHRINE HCL
Brand/Generic	Generic
Proprietary Name	Childrens Cold and Allergy Relief
Proprietary Name Suffix	n/a
Non-Proprietary Name	Brompheniramine maleate, Phenylephrine HCl
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	ORAL
Active Ingredient Strength	2; 5
Active Ingredient Units	mg/10mL; mg/10mL
Substance Name	BROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE
Labeler Name	Strategic Sourcing Services LLC
Pharmaceutical Class	Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part341
Listing Certified Through	2024-12-31

Package

Package Images

NDC 70677-0101-01 (70677010101)

Pricing Information
NDC Package Code	70677-0101-1
Billing NDC	70677010101
Package	1 BOTTLE, PLASTIC in 1 BOX (70677-0101-1) / 118 mL in 1 BOTTLE, PLASTIC
Marketing Start Date	2020-01-31
NDC Exclude Flag	N
Price Per Unit	0.01963
Pricing Unit	ML
Effective Date	2023-01-18
NDC Description	SM CHILD COLD-ALLERGY LIQUID
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	4, 5
Classification for Rate Setting	G
As of Date	2024-01-10

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 d64fe757-9948-4727-b5dd-1f8e4e4763e2 Details

Active ingredients (in each 10 mL)

Brompheniramine maleate 2 mg

Phenylephrine HCI 5 mg

Purposes

Antihistamine

Nasal decongestant

Uses

temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
temporarily relieves these symptoms due to hay fever (allergic rhinitis)
- runny nose
- itchy, watery eyes
- sneezing
- itching of the nose or throat
temporarily restores freer breathing through the nose

Warnings

Do not use

to sedate a child or to make a child sleepy
if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

heart disease
high blood pressure
thyroid disease
diabetes
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 any other oral nasal decongestant or stimulant
taking sedatives or tranquilizers

When using this product

do not use more than directed
drowsiness may occur
avoid alcoholic beverages
alcohol, sedatives, and tranquilizers may increase drowsiness
be careful when driving a motor vehicle or operating machinery
excitability may occur, especially in children

Stop use and ask a doctor if

nervousness, dizziness or sleeplessness occur
symptoms do not get better within 7 days or are accompanied by fever

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 (1-800-222-1222) right away.

Directions

do not take more than 6 doses in any 24-hour period
measure only with dosing cup provided. Do not use any other dosing device.
keep dosing cup with product
mL = milliliter

age	dose
adults and children 12 years and over	20 mL every 4 hours
children 6 to 11 years	10 mL every 4 hours
children under 6 years	do not use

Other information

each 10 mL contains: sodium 6 mg
store at 20 to 25°C (68 to 77°F). Do not refrigerate.

Inactive ingredients

anhydrous citric acid, FD&C blue #1, FD&C red # 40, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate

Questions or comments?

Call 1-833-358-6431 Monday to Friday 9:00 AM to 7:00 PM EST

Principal Display Panel

*COMPARE TO THE ACTIVE INGREDIENTS IN CHILDREN'S DIMETAPP® COLD & ALLERGY

Children's

Cold & Allergy

Brompheniramine Maleate 2 mg

Antihistamine

Phenylephrine HCl 5 mg

Nasal Decongestant

Relieves Itchy, Watery Eyes, Runny Nose, Sneezing, Stuffy Nose, Itchy of the Nose or Throat

For Ages 6 Years And Over

Alcohol-free

GRAPE FLAVOR

FL OZ (mL)

*This product is not manufactured or distributed by Foundation Consumer Brands, LLC, distributors of Children's Dimetapp® Cold & Allergy.

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.

Distributed by McKesson Corp.,

via Strategic Sourcing Services LLC, Memphis, TN 38141

www.sunmarkbrand.com

Package Label

Brompheniramine Maleate 2 mg, Phenylephrine HCl 5 mg

SUNMARK Children's Cold & Allergy Grape Flavor

INGREDIENTS AND APPEARANCE

CHILDRENS COLD AND ALLERGY RELIEF

brompheniramine maleate, phenylephrine hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70677-0101
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BROMPHENIRAMINE MALEATE (UNII: IXA7C9ZN03) (BROMPHENIRAMINE - UNII:H57G17P2FN)	BROMPHENIRAMINE MALEATE	2 mg in 10 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg in 10 mL

Ingredient Name	Strength
Inactive Ingredients
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)

Product Characteristics
Color		Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70677-0101-1	1 in 1 BOX	01/31/2020
1		118 mL in 1 BOTTLE, PLASTIC; 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	01/31/2020

Labeler - Strategic Sourcing Services LLC (116956644)

Revised: 8/2022

Document Id: 1b678869-be0b-4cfc-a9bd-0e523472867e

Set id: d64fe757-9948-4727-b5dd-1f8e4e4763e2

Version: 2

Effective Time: 20220830