EQUALINE CHILDRENS COLD AND COUGH- brompheniramine maleate, dextromethorphan hydrobromide and phenylephrine hydrochloride liquid 
Supervalu Inc

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.

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SuperValu Inc. Children’s Cold & Cough Drug Facts

Active ingredient (in each 5 mL teaspoonful)

Brompheniramine maleate, USP 1 mg

Dextromethorphan HBr, USP 5 mg

Phenylephrine HCl, USP 2.5 mg

Purpose

Antihistamine

Cough suppressant

Nasal decongestant

Uses

temporarily relieves cough due to minor throat and bronchial irritation occurring with a cold, and nasal congestion due to the common cold, hay fever or other upper respiratory allergies
temporarily relieves these symptoms due to hay fever (allergic rhinitis):
sneezing
itching of the nose or throat
runny nose
itchy, watery eyes
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

a breathing problem such as emphysema or chronic bronchitis
glaucoma
thyroid disease
high blood pressure
heart disease
diabetes
cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
cough that occurs with too much phlegm (mucus)
trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers

When using this product

do not use more than directed
may cause marked drowsiness
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
cough lasts for more than 7 days, comes back, or occurs with fever, rash or persistent headache. A persistent cough may be a sign of a serious condition.

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

do not take more than 6 doses in any 24-hour period

age

dose

adults and children 12 years and over

4 tsp every 4-6 hours

children 6 to under 12 years

2 tsp every 4-6 hours

children 4 to under 6 years

do not use unless directed by a doctor

children under 4 years

do not use

Other information

each teaspoon contains: sodium 2 mg
store at 20°-25°C (68°-77°F)
not a USP elixir

Inactive ingredients

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

Questions or comments?

1-877-932-7948

Principal Display Panel

compare to Children’s Dimetapp® Cold & Cough active ingredients

for ages 6 & up

children’s

cold & cough

brompheniramine maleate, antihistamine

dextromethorphan HBr, cough suppressant

phenylephrine HCl, nasal decongestant

relieves:

stuffy nose

runny nose

sneezing

itchy, watery eyes

cough

alcohol free

grape flavor

Children's Cold & Cough Carton
EQUALINE CHILDRENS COLD AND COUGH 
brompheniramine maleate, dextromethorphan hbr, phenylephrine hcl liquid
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:41163-987
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BROMPHENIRAMINE MALEATE (BROMPHENIRAMINE) BROMPHENIRAMINE MALEATE1 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
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 DescriptionMarketing Start DateMarketing End Date
1NDC:41163-987-261 in 1 CARTON
1118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/27/2012
Labeler - Supervalu Inc (006961411)

Revised: 10/2012
 
Supervalu Inc