ZoDEN

Dosage form: solution/ drops
Ingredients: GUAIFENESIN 20mg in 1mL, PHENYLEPHRINE HYDROCHLORIDE 1.5mg in 1mL
Labeler: TRIGEN Laboratories, Inc.
NDC Code: 13811-079

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.

ZoDEN
DROPS

Drug Facts

Active Ingredients (in each 1 mL dropperful)Purpose
Guaifenesin 20 mgExpectorant
Phenylephrine HCl 1.5 mgDecongestant

Uses

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

  • runny nose
  • sneezing
  • itching of the nose or throat
  • itchy, watery eyes
  • nasal congestion
  • reduces swelling of nasal passages
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive

Warnings

Do not exceed recommended dosage.

Do not use this product

  • In a child who is 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 the child has

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • a persistent or chronic cough that occurs with too much phlegm (mucus)
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes mellitus

Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers.

When using this product

  • excitability may occur, especially in children
  • may cause marked drowsiness
  • be careful when driving a motor vehicle or operating machinery

Stop 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.
  • new symptoms occur

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.

Directions

Do not exceed recommended dosage.

Children 6 to under 12 years of age: 2 dropperfuls (2 mL) every 4 to 6 hours, not to exceed 4 doses (8 dropperfuls) in a 24 hour period

Children under 6 years of age: Consult a physician

Other Information

Store at controlled room temperature 15° - 30° C (59° - 86° F). [See USP].

Inactive Ingredients

Citric Acid, FD&C Red #40, Methyl Paraben, Potassium Citrate, Potassium Sorbate, Propyl Paraben, Propylene Glycol, Purified Water, Raspberry flavor, Sorbitol Solution 70%, Sucralose

Question? Comments?

Call your doctor about side effects. You may report side effects by calling 888 9 TRIGEN (888-987-4436).

PRINCIPAL DISPLAY PANEL - 30 ML Bottle Label

NDC 13811- 0079-30

ZoDEN
DROPS

EXPECTORANT • DECONGESTANT
SUGAR FREE • ALCOHOL FREE

Each dropperful (1 mL) for oral
administration contains:
Guaifenesin20 mg
Phenylephrine
HCl
1.5 mg

RASPBERRY FLAVOR

1 FL. OZ. (30 ML)

ZODEN 
guaifenesin and phenylephrine hydrochloride solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13811-079
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN20 mg  in 1 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE1.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
FD&C RED NO. 40 
METHYLPARABEN 
POTASSIUM CITRATE 
POTASSIUM SORBATE 
PROPYLPARABEN 
PROPYLENE GLYCOL 
WATER 
SORBITOL 
SUCRALOSE 
Product Characteristics
Color    Score    
ShapeSize
FlavorRASPBERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:13811-079-3030 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34101/01/2011
Labeler - TRIGEN Laboratories, Inc. (830479668)
Establishment
NameAddressID/FEIOperations
TG United Liquid, Inc.830980947MANUFACTURE

Revised: 07/2011
 
TRIGEN Laboratories, Inc.

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.

Hide
(web3)