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Cough Relief Orange by Aaron Industries, Inc.

Dosage form: liquid
Ingredients: DEXTROMETHORPHAN HYDROBROMIDE 15mg in 5mL
Labeler: Aaron Industries, Inc.
NDC Code: 49580-3104

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.

Drug Facts

Active Ingredients

Dextromethorphan HBr USP 15 mg

Purpose

Dextromethorphan HBr USP.........................Cough suppressant

Do Not Use

• if you are on a sodium-restricted diet
• 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

• cough that occurs with too much phlegm (mucus)
• persistent or chronic cough such as occurs with smoking,
asthma or emphysema

Stop use and ask a doctor if

• cough lasts more than 7 days, comes back, or is accompanied by
fever, rash or persistent headache. These could be signs of a serious
condition.

When using this product

• do not use more than directed

If pregnant or breast-feeding

ask a health professional before use.

Keep this and all drugs out of the reach of children.

In case of accidental overdose, seek professional assistance
or contact a Poison Control Center immediately.

Directions

• take recommended dosage or as directed by a doctor

age                                                                             dose
adults and children 12 years and over.................2 teaspoonfuls every 6-8 hours, not to exceed 4 doses in 24 hours
children 6 years to under 12 years........................1 teaspoonful every 6-8 hours, not to exceed 4 doses in 24 hours
children 4 years 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 6 mg
• store at controlled room temperature

Inactive Ingredients

citric acid, edetate disodium, flavor, glycerin,
high fructose corn syrup, hydroxyethyl cellulose,
polyethylene glycol 3350, propylene glycol,
purified water, sodium benzoate, sucralose,
sucrose, tragacanth, xanthan gum, yellow 6

Uses

temporarily relieves cough due to minor throat and bronchial
irritation as may occur with the common cold or inhaled irritants

Principal Display Panel

Best Choice

Cough Relief

Up to 8 hours of Cough Relief

Orange Flavor

Alcohol-Free

4 FL OZ (118 mL)

COUGH RELIEF  ORANGE
dextromethorphan hydrobromide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49580-3104
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE15 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
EDETATE DISODIUM 
Glycerin 
High Fructose Corn Syrup 
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) 
Polyethylene Glycol 3350 
Propylene Glycol 
Water 
Sodium Benzoate 
Sucralose 
Sucrose 
Tragacanth 
Xanthan Gum 
FD&C YELLOW NO. 6 
Product Characteristics
Color    Score    
ShapeSize
FlavorORANGE (Orange Flavor) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:49580-3104-4118 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34111/21/2009
Labeler - Aaron Industries, Inc. (101896231)
Registrant - Aaron Industries, Inc. (101896231)
Establishment
NameAddressID/FEIOperations
Aaron Industries, Inc.101896231manufacture, analysis

Revised: 11/2009
 
Aaron Industries, 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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