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Sunmark Cold and Allergy Childrens

Dosage form: liquid
Ingredients: PHENYLEPHRINE HYDROCHLORIDE 5mg in 10mL, BROMPHENIRAMINE MALEATE 2mg in 10mL
Labeler: McKesson
NDC Code: 49348-777

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

McKesson Cold & Allergy Drug Facts

Active ingredients (in each 10 mL)

Brompheniramine maleate, USP 2 mg

Phenylephrine HCl, USP 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
sneezing
itchy, watery eyes
itching of the nose or throat
temporarily restores freer breathing through the nose

Warnings

Do not use
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.
to make a child sleepy

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 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
you get nervous, dizzy or sleepless
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 right away (1-800-222-1222).

Directions
do not take more than 6 doses in any 24-hour period
measure only with dosage cup provided
keep dosage cup with product
mL = milliliter

age

dose

adults and children 12 years and over

20 mL every 4 hours

children 6 to under 12 years

10 mL every 4 hours

children under 6 years

do not use

Other information
each 10 mL contains: sodium 4 mg
store at 20-25°C (68-77°F)

Inactive ingredients

anhydrous citric acid, edetate disodium, FD&C blue no. 1, FD&C red no. 40, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol solution

Questions or comments?

1-800-719-9260

Principal Display Panel

COMPARE TO CHILDREN’S DIMETAPP® COLD & ALLERGY ACTIVE INGREDIENTS

for ages 6 & up

Children’s

cold & allergy

ANTIHISTAMINE

Brompheniramine Maleate

NASAL DECONGESTANT

Phenylephrine HCl

Relieves cold & allergy symptoms

Alcohol Free

GRAPE FLAVORED

GLUTEN FREE

4 FL OZ (118 mL)

SUNMARK COLD AND ALLERGY  CHILDRENS
phenylephrine hcl, brompheniramine maleate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49348-777
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 10 mL
BROMPHENIRAMINE MALEATE (BROMPHENIRAMINE) BROMPHENIRAMINE MALEATE2 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID 
EDETATE DISODIUM 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
GLYCERIN 
PROPYLENE GLYCOL 
WATER 
SACCHARIN SODIUM 
SODIUM BENZOATE 
SORBITOL 
Product Characteristics
ColorPURPLE (clear bluish-red) Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:49348-777-341 BOTTLE in 1 CARTON
1118 mL in 1 BOTTLE
2NDC:49348-777-371 BOTTLE in 1 CARTON
2236 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/11/2006
Labeler - McKesson (177667227)

Revised: 05/2016
 
McKesson

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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