ZoDen PD description, usages, side effects, indications, overdosage, supplying and lots more!

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ZoDen PD

TRIGEN Laboratories, Inc.

ZoDen PD


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

Active Ingredients (in each 5 mL teaspoonful) Purpose
Diphenhydramine HCl 25 mg Antihistamine
Phenylephrine HCl 7.5 mg Decongestant

ZoDen PD 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

ZoDen PD 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 HCl 25 mg
Phenylephrine HCl 7.5 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

ZoDen PD

Diphenhydramine Hydrochloride and Phenylephrine Hydrochloride LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:13811-073
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE 25 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 7.5 mg

Inactive Ingredients

Ingredient Name Strength
CITRIC ACID MONOHYDRATE
METHYLPARABEN
POTASSIUM CITRATE
POTASSIUM SORBATE
PROPYLPARABEN
propylene glycol
water
sorbitol
Sucralose

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13811-073-30 473 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2010-01-01


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Be sure to consult your doctor before taking any medication!
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