OTC Medication Information: Z-DEX

Z-DEX — dextromethorphan hydrobromide, guaifenesin and phenylephrine hydrochloride liquid
Trigen Laboratories

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.

Drug Facts

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

Purpose

Antitussive

(cough suppressant)

Expectorant

Nasal Decongestant

Uses

temporarily 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

Warnings

Do 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 Information

Store at 59° — 86° F(15° — 30° C)

Inactive ingredients

Citric 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 Packaging
(click image for full-size original)
Z-DEX Packaging
(click image for full-size original)
Z-DEX Packaging
(click image for full-size original)
Z-DEX dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:13811-001
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Dextromethorphan Hydrobromide (Dextromethorphan) Dextromethorphan Hydrobromide 3 mg in 1 mL
Guaifenesin (Guaifenesin) Guaifenesin 35 mg in 1 mL
Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride 2.5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
Citric Acid
Glycerin
Propylene Glycol
Water
Sodium Citrate
Saccharin Sodium
Sorbitol
Product Characteristics
Color Score
Shape Size
Flavor GRAPE Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:13811-001-30 1 BOTTLE (BOTTLE) in 1 CARTON contains a BOTTLE
1 30 mL in 1 BOTTLE This package is contained within the CARTON (13811-001-30)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 05/06/2010
Labeler — Trigen Laboratories (830479668)

Revised: 10/2010 Trigen Laboratories

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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