Medication Guide App

Z-DEX

Dosage form: liquid
Ingredients: Dextromethorphan Hydrobromide 3mg in 1mL, Guaifenesin 35mg in 1mL, Phenylephrine Hydrochloride 2.5mg in 1mL
Labeler: Trigen Laboratories
NDC Code: 13811-001

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.

Z-DEX Pediatric Drops

Drug Facts (in each 1 mL dropperful)
Dextromethorphan Hydrobromide 3 mg
Guaifenesin 35 mg
Phenylephrine Hydrochloride 2.5 mg

PurposeAntitussive
(cough suppressant)
Expectorant
Nasal Decongestant

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

  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
  • cough due to minor throat and bronchial irritation
  • nasal congestion
  • reduces swelling of nasal passages

WarningsDo not exceed recommended dosage.

Do not use this product
  • if your child is 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 child's prescription contains an MAOI, ask a doctor or pharmacist before giving this product.

Ask a doctor before use if your child has
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • a cough that lasts or is chronic such as occurs with asthma
  • a cough that occurs with too much phlegm (mucus)

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.  Theses could be signs of a serious condition.

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 recommended dosage.

Use only with enclosed dropper.
Do not use with any other dosage device.


Children 6 to under 12 years of age:  2 dropperfuls (2 mL) every 4 hours not to exceed 6 doses in 24 hours
Children under 6 years of age:  consult a doctor

Other InformationStore at 59° - 86° F(15° - 30° C)

Inactive ingredientsCitric Acid, FD and C Blue #1, FD and C Red #40, Glycerin, Grape Flavor, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol.

Questions? Comments?Call 732-721-0070 Mon. - Fri. (8am to 5pm) EST
Call your doctor for medical advice about side effects.  Serious side effects associated with the use of this product may be reported to this number.

Product Packaging:Packaging below represents labeling currently used:

Principal display panel and side panel for 30 mL label:

NDC 13811-001-30

Z-DEX Pediatric Drops

Triple Action / Antitussive / Expectorant / Nasal Decongestant / Alcohol Free / Sugar Free

Grape flavor

Each 1 ml (dropperful) for oral administration contains:
Dextromethorphan Hydrobromide..........................................3 mg
Guaifenesin.......................................................................35 mg
Phenylephrine Hydrochloride..............................................2.5 mg

Net Contents:  1 fl. oz. (30 mL)

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

Supplied in a tight, light-resistant container with a child-resistant cap.

Store at 59° to 86°F (15° to 30°C)

Manufactured for:
TRIGEN Laboratories, Inc.
Sayreville, NJ  08872                         Rev. 03/10













Z-DEX  
dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13811-001
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dextromethorphan Hydrobromide (Dextromethorphan) Dextromethorphan Hydrobromide3 mg  in 1 mL
Guaifenesin (Guaifenesin) Guaifenesin35 mg  in 1 mL
Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride2.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Citric Acid 
Glycerin 
Propylene Glycol 
Water 
Sodium Citrate 
Saccharin Sodium 
Sorbitol 
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:13811-001-301 BOTTLE (BOTTLE) in 1 CARTON
130 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/06/2010
Labeler - Trigen Laboratories (830479668)

Revised: 10/2010
 
Trigen Laboratories

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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