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Z-TUSS E

Dosage form: liquid
Ingredients: Codeine Phosphate 9mg in 5mL, Guaifenesin 200mg in 5mL, Pseudoephedrine Hydrochloride 30mg in 5mL
Labeler: Magna Pharmaceuticals, Inc.
NDC Code: 58407-239

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.

Z-TUSS E

Drug Facts Active ingredients
(in each 5 mL teaspoonful)

Codeine Phosphate* 9 mg
*(WARNING:  May be habit-forming)
Guaifenesin 200 mg
Pseudoephedrine HCl 30 mg

PurposeAntitussive
(cough suppressant)
Expectorant
Nasal Decongestant

Usestemporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:
  • Cough due to minor throat and bronchial irritation
  • Helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
  • Nasal congestion
  • Reduces swelling of nasal passages

Warnings Do not exceed recommended dosage.

Do not use this product
  • if you are 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 you have
  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema
  • cough that occurs with too much phlegm (mucus)
  • chronic pulmonary disease or shortness of breath, or children who are taking other drugs
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland

When using this product
  • May cause or aggravate constipation

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.  A persistent cough may be a sign of a serious condition.
  • new symptoms occur

If pregnant or breast-feeding, ask a health professional before use.

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 4 doses in 24 hours
Adults and children 12 years
and over:

2 teaspoonfuls (10 mL) every
4 to 6 hours, not to exceed
8 teaspoonfuls in 24 hours
Children 6 to under 12 years
of age;
1 teaspoonful (5 mL) every
4 to 6 hours, not to exceed
4 teaspoonfuls in 24 hours
Children under 6 years of age:
Consult a doctor
A special measuring device should be used to give an accurate dose of this product to children under 6 years of age.  Giving a higher dose than recommended by a doctor could result in serious side effects for your child.

Other informationStore at controlled room temperature 15°-30°C (59°-86°F).

Inactive ingredientsCherry Flavor, Citric Acid, Glycerin, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol.

Questions? Comments?To report serious side effects associated with the use of this product call 1-888-206-5525

Manufactured for:
MAGNA Pharmaceuticals, Inc.
10801 Electron Drive, Suite 100
Louisville, KY  40299
www.magnaweb.com

Rev. 08/11

Product PackagingThe packaging below represents the labeling currently used.

Principal display panel for 473 mL label:

NDC 58407-239-16

Z-TUSS E


Antitussive (cough suppressant) /
Expectorant / Nasal Decongestant

Cherry flavor

CV

Each 5 mL (one teaspoonful) for oral
administration contains:

Codeine Phosphate*.....................9 mg
*(WARNING:  May be habit-forming)
Guaifenesin..............................200 mg
Pseudoephedrine
Hydrochloride.............................30 mg

Alcohol Free / Gluten Free
Sugar Free / Dye Free

        TAMPER EVIDENT:
Do not use if foil seal under cap is broken
        or missing.

THIS BOTTLE IS NOT TO BE DISPENSED
        TO CONSUMER.

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

16 fl oz. (473 mL)





Z-TUSS   E
codeine phosphate/guaifenesin/pseudoephedrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58407-239
Route of AdministrationORALDEA ScheduleCV    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Codeine Phosphate (Codeine) Codeine Phosphate9 mg  in 5 mL
Guaifenesin (Guaifenesin) Guaifenesin200 mg  in 5 mL
Pseudoephedrine Hydrochloride (Pseudoephedrine) Pseudoephedrine Hydrochloride30 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
Citric Acid 
Glycerin 
Propylene Glycol 
Water 
Sodium Citrate 
Saccharin Sodium 
Sorbitol 
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:58407-239-16473 mL in 1 BOTTLE, PLASTIC
2NDC:58407-239-0115 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/12/2011
Labeler - Magna Pharmaceuticals, Inc. (620988360)
Registrant - Great Southern Laboratories (056139553)
Establishment
NameAddressID/FEIOperations
Great Southern Laboratories056139553manufacture

Revised: 10/2011
 
Magna Pharmaceuticals, 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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