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equaline cough dm by Supervalu Inc

Dosage form: suspension
Ingredients: DEXTROMETHORPHAN HYDROBROMIDE 30mg in 5mL
Labeler: Supervalu Inc
NDC Code: 41163-384

SuperValu Inc. Cough DM Drug Facts

Active ingredient (in each 5 mL)

Dextromethorphan polistirex equivalent to 30 mg dextromethorphan hydrobromide, USP

Purpose

Cough suppressant

Uses

temporarily relieves

cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
the impulse to cough to help you get to sleep

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.

Allergy Alert: Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions.

Ask a doctor before use if you have
chronic cough that lasts as occurs with smoking, asthma or emphysema
cough that occurs with too much phlegm (mucus)

Stop use and ask a doctor if
side effects occur. You may report side effects to FDA at 1-800-FDA-1088.
cough lasts more than 7 days, cough comes back, or occurs with fever, rash or headache that lasts. These could be signs 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
shake bottle well before use
measure only with dosing cup provided. Do not use dosing cup with other products.
dose as follows or as directed by doctor
mL = milliliter

adults and children 12 years of age and over

10 mL every 12 hours, not to exceed 20 mL in 24 hours

children 6 to under 12 years of age

5 mL every 12 hours, not to exceed 10 mL in 24 hours

children 4 to under 6 years of age

2.5 mL every 12 hours, not to exceed 5 mL in 24 hours

children under 4 years of age

do not use

Other information
each 5 mL contains: sodium 5 mg
store at 20° to 25°C (68° to 77°F)
dosing cup provided

Inactive Ingredients

D&C Red #30 aluminum lake, D&C Yellow #10 aluminum lake, flavor, glycerin, high fructose corn syrup, methylparaben, polysorbate 80, polyvinyl acetate, povidone, propylparaben, purified water, sodium metabisulfite, sodium polystyrene sulfonate, sucrose, tartaric acid, tragacanth gum, triacetin, xanthan gum

Questions or comments?

1-877-932-7948

Package/Label Principal Display Panel

compare to Delsym® active ingredient

cough DM

dextromethorphan polistirex extended-release oral suspension

cough suppressant

12 hour cough relief

contains sodium metabisulfite, a sulfite that may cause allergic-type reactions

alcohol-free

dosing cup included

orange-flavored liquid

EQUALINE COUGH DM 
dextromethorphan polistirex suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41163-384
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE30 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
POLISTIREX 
HIGH FRUCTOSE CORN SYRUP 
GLYCERIN 
METHYLPARABEN 
POLYSORBATE 80 
POVIDONES 
PROPYLPARABEN 
WATER 
SODIUM METABISULFITE 
SODIUM POLYSTYRENE SULFONATE 
SUCROSE 
TARTARIC ACID 
TRAGACANTH 
TRIACETIN 
XANTHAN GUM 
Product Characteristics
ColorORANGEScore    
ShapeSize
FlavorORANGEImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:41163-384-211 BOTTLE in 1 CARTON
189 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09113510/19/2012
Labeler - Supervalu Inc (006961411)

Revised: 11/2012
 
Supervalu Inc

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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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