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Good Sense Childrens Cold and Cough

Dosage form: solution
Ingredients: BROMPHENIRAMINE MALEATE 2mg in 10mL, DEXTROMETHORPHAN HYDROBROMIDE 10mg in 10mL, PHENYLEPHRINE HYDROCHLORIDE 5mg in 10mL
Labeler: L. Perrigo Company
NDC Code: 0113-0987

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.

Perrigo Children's Cold & Cough Drug Facts

Active ingredients (in each 10 mL)

Brompheniramine maleate, USP 2 mg

Dextromethorphan HBr, USP 10 mg

Phenylephrine HCl, USP 5 mg

Purposes

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

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 is accompanied by 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 (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

Ages 6 Yrs. & Over

Children’s

Cold & Cough

Antihistamine, Brompheniramine Maleate

Cough Suppressant, Dextromethorphan HBr

Nasal Decongestant, Phenylephrine HCl

Stuffy Nose

Runny Nose

Sneezing

Itchy, Watery Eyes

Coughing

Alcohol-Free

Grape Flavor

Compare to active ingredients of Children's Dimetapp® Cold & Cough

4 FL OZ (118 mL)

GOOD SENSE CHILDRENS COLD AND COUGH 
brompheniramine maleate, dextromethorphan hbr, phenylephrine hcl solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0113-0987
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BROMPHENIRAMINE MALEATE (BROMPHENIRAMINE) BROMPHENIRAMINE MALEATE2 mg  in 10 mL
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 10 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 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:0113-0987-261 BOTTLE in 1 CARTON
1118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34102/24/2007
Labeler - L. Perrigo Company (006013346)

Revised: 05/2016
 
L. Perrigo Company

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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