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.
Drug Facts
(in each 1 mL dropperful)
Dextromethorphan Hydrobromide 3 mg
Guaifenesin 35 mg
Phenylephrine Hydrochloride 2.5 mg
Dextromethorphan Hydrobromide 3 mg
Guaifenesin 35 mg
Phenylephrine Hydrochloride 2.5 mg
PurposeAntitussive
(cough suppressant)
Expectorant
Nasal Decongestant
(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
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.
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
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 |
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| Labeler - Trigen Laboratories (830479668) |
Revised: 10/2010
Document Id: 99f4a479-f2ad-4f54-ba1b-489d31c17ef5
Set id: d6c4c186-a6cd-4315-869c-0a3a97f448f7
Version: 1
Effective Time: 20101012
Trigen Laboratories
See also...
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 drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
