Medication Guide App

Entex S

Dosage form: liquid
Ingredients: DEXTROMETHORPHAN HYDROBROMIDE 20mg in 5mL
Labeler: WraSer Pharmaceuticals, LLC
NDC Code: 66992-290

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.

Entex S DM Liquid

Drug Facts

Active Ingredients

In each 5 mL (1 teaspoonful) liquid

Dextromethorphan HBr, USP   20 mg

Purpose

Dextromethorphan HBr                Antitussive

Uses

Temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold

Warnings

Do not exceed recommended dosage

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 drug.

Ask a doctor before use if you have
  • a cough that occurs with too much phlegm (mucus)
  • a cough that lasts or is chronic 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.

If pregnant or breast-feeding,
  • ask a health professional before use.

Keep out of the reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions
  • Do not exceed 4 doses in any 24 hour period
  • Adults and children 12 years of age and over: 1 teaspoon every 4 hours.
  • Children 6 to under 12 years of age: 1/2 teaspoon every 4 hours.

Other information

store at 20°- 25°C (68°- 77°F)

Inactive Ingredients

Benzoic acid, edetate disodium, FD&C Red #40, propylene glycol, purified water, saccharin sodium, sorbitol solution and strawberry flavoring

Questions or Comments

Call weekdays from 9 AM to 4 PM CST at 1-888-252-3901 or go to http://www.wraser.com

email: medicalinfo@wraser.com

Principal Display Panel

ENTEX S 
dextromethorphan hydrobromide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66992-290
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
BENZOIC ACID 
EDETATE DISODIUM 
FD&C RED NO. 40 
PROPYLENE GLYCOL 
WATER 
SACCHARIN SODIUM 
SORBITOL 
Product Characteristics
ColorREDScore    
ShapeSize
FlavorSTRAWBERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:66992-290-04118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/30/201108/31/2013
Labeler - WraSer Pharmaceuticals, LLC (121828334)
Registrant - WraSer Pharmaceuticals, LLC (121828334)
Establishment
NameAddressID/FEIOperations
Sovereign Pharmaceuticals, LLC623168267MANUFACTURE(66992-290)

Revised: 12/2012
 
WraSer Pharmaceuticals, LLC

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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