ZoDen PD

Dosage form: liquid
Ingredients: Diphenhydramine Hydrochloride 25mg in 5mL, Phenylephrine Hydrochloride 7.5mg in 5mL
Labeler: TRIGEN Laboratories, Inc.
NDC Code: 13811-073

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 PD

Drug Facts

Active Ingredients (in each 5 mL teaspoonful)Purpose
Diphenhydramine HCl 25 mgAntihistamine
Phenylephrine HCl 7.5 mgDecongestant

Uses

temporarily relieves

  • runny nose
  • sneezing
  • itching of the nose or throat
  • itchy, watery eyes due to hay fever
  • nasal congestion
  • sinus congestion and pressure

Warnings

Do not exceed recommended dosage.

Do not use this product

  • 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

Do not use this product, unless directed by a doctor, if you have

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes

Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor.

When using this product
  • may cause marked drowsiness
  • may cause excitability especially in children
  • alcohol, sedatives, and tranquilizers may increase the drowsiness effect
  • avoid alcoholic beverages
  • use caution when driving a motor vehicle or operating machinery

Stop use and ask doctor if
  • nervousness, dizziness, or sleeplessness occur
  • if symptoms do not improve within 7 days or are accompanied by a fever

Keep out of reach of children.

In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.

Directions

Do not exceed recommended dosage.

Adults and children 12 years of age and over:1 teaspoonful (5 mL) every 4 to 6 hours, not to exceed 6 teaspoonfuls in 24 hours, or as directed by a doctor
Children 6 to under 12 years of age:1/2 teaspoonful (2.5 mL) every 4 to 6 hours, not to exceed 3 teaspoonfuls in 24 hours, or as directed by a doctor
Children 2 to under 6 years of age:Consult a doctor

Other information

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

Inactive ingredients

Citric Acid, Cotton Candy Flavor, Gum Fruit Flavor, Methyl Paraben, Potassium Citrate, Potassium Sorbate, Propyl Paraben, Propylene Glycol, Purified Water, Sorbitol Solution 70%, Sucralose

Question? Comments?

Call 1-732-721-0070

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

NDC 13811-0073-16

ZoDen PD

Antihistamine • Decongestant

Sugar Free ■ Alcohol Free ■ Gluten Free

Each teaspoonful (5 mL) for oral
administration contains:

Diphenhydramine HCl25 mg
Phenylephrine HCl7.5 mg

Fruit Candy Flavor

This bottle is not to be dispensed to
consumer.

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

Dispense in a tight container with
a child-resistant cap.

Manufactured for:
TRIGEN
LABORATORIES
Sayreville, NJ 08872

16 fl oz (473 mL)

ZODEN PD 
diphenhydramine hydrochloride and phenylephrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13811-073
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Diphenhydramine Hydrochloride (Diphenhydramine) Diphenhydramine Hydrochloride25 mg  in 5 mL
Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride7.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
METHYLPARABEN 
POTASSIUM CITRATE 
POTASSIUM SORBATE 
PROPYLPARABEN 
PROPYLENE GLYCOL 
WATER 
SORBITOL 
SUCRALOSE 
Product Characteristics
Color    Score    
ShapeSize
FlavorCOTTON CANDYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:13811-073-30473 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/01/201006/30/2014
Labeler - TRIGEN Laboratories, Inc. (830479668)
Establishment
NameAddressID/FEIOperations
TG United Liquid, Inc.830980947manufacture(13811-073)

Revised: 07/2013
 
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.

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