ENTEX S  - dextromethorphan hydrobromide liquid 
WraSer Pharmaceuticals, LLC

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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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 take more than 4 doses in any 24-hour period
AgeDose
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, editate 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

Figure 1: Bottle Label, 4 oz.

6665aef9-figure-01


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 DescriptionMultilevel Packaging
1NDC:66992-290-04118 mL in 1 BOTTLENone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/30/2011

Labeler - WraSer Pharmaceuticals, LLC (121828334)
Registrant - WraSer Pharmaceuticals, LLC (121828334)
Establishment
NameAddressID/FEIOperations
Sovereign Pharmaceuticals, LLC623168267MANUFACTURE

Revised: 09/2011 WraSer Pharmaceuticals, LLC