GLENTUSS- dextromethorphan hydrobromide, pseudoephedrine hydrochloride, and doxylamine succinate syrup 
Glendale Inc

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.

----------

Glentuss

Drug Facts

Active ingredients (in each teaspoonful)Purpose
Dextromethorphan Hydrobromide 15 mgAntitussive (cough suppressant)
Pseudoephedrine Hydrochloride 30 mgNasal Decongestant
Doxylamine Succinate 6.25 mgAntihistamine

Uses

temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:

Warnings

Do not exceed recommended dosage.

Do not use this product

  • to sedate a child or make a child sleepy
  • 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

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis
  • a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
  • a cough that occur with too much phlegm (mucus)

Ask a doctor or pharmacist before use if you are

  • taking any other nasal decongestant or stimulant
  • taking sedatives or tranquilizers

When using this product

  • marked drowsiness may occur
  • avoid alcoholic drinks
  • 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

  • nervousness, dizziness, or sleeplessness occur
  • cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a 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 reach of children.

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

Directions

Do not exceed 4 dosage in a 24-hour period.

Adults and children 12 years of age and over:2 teaspoonfuls every 6 hours
Children under 12 years of age:Consult a physician

Other information

Store at 59°-86°F (15°-30°C) [see USP for Controlled Room Temperature]

Inactive ingredients

Apple candy flavor, citric acid, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol.

Questions? Comments?

To report a serious adverse event or obtain product information, Call 1-630-530-7000.

Distributed by:
Glendale Inc
Villa, Park, IL 60181

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

NDC 70147-0233-16

Glentuss

Antitussive
Nasal Decongestant
Antihistamine

Each teaspoonful for oral
administration contains:

Dextromethorphan HBr 15 mg
Pseudoephedrine HCl 30 mg
Doxylamine Succinate 6.25 mg

SUGAR FREE / DYE FREE
ALCOHOL FREE

Apple Candy Flavored Liquid

Tamper evident by foil seal under cap.
Do not use if foil seal is broken or missing.

Distributed by:
Glendale Inc
Villa Park, IL 60181

16 fl oz. (473 mL)

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
GLENTUSS 
dextromethorphan hydrobromide, pseudoephedrine hydrochloride, and doxylamine succinate syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70147-233
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg  in 5 mL
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE30 mg  in 5 mL
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SORBITOL (UNII: 506T60A25R)  
GLYCERIN (UNII: PDC6A3C0OX)  
Product Characteristics
Color    Score    
ShapeSize
FlavorAPPLEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70147-233-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34112/05/2015
Labeler - Glendale Inc (079987961)

Revised: 12/2015
Document Id: f23182eb-a618-4556-a265-3de318cc7ae5
Set id: 8a6eb670-8bed-4941-b4fd-70b3f1e48401
Version: 1
Effective Time: 20151209
 
Glendale Inc