Z-TUSS E- codeine phosphate/guaifenesin/pseudoephedrine hydrochloride liquid
Magna Pharmaceuticals, Inc.

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.

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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

Purpose

Antitussive
(cough suppressant)
Expectorant
Nasal Decongestant

Uses

temporarily 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 information

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

Inactive ingredients

Cherry 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 Packaging

The 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 Packaging

Z-TUSS E
codeine phosphate/guaifenesin/pseudoephedrine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58407-239
Route of Administration	ORAL	DEA Schedule	CV

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Codeine Phosphate (UNII: GSL05Y1MN6) (Codeine Anhydrous - UNII:UX6OWY2V7J)	Codeine Phosphate	9 mg in 5 mL
Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ)	Guaifenesin	200 mg in 5 mL
Pseudoephedrine Hydrochloride (UNII: 6V9V2RYJ8N) (Pseudoephedrine - UNII:7CUC9DDI9F)	Pseudoephedrine Hydrochloride	30 mg in 5 mL

Ingredient Name	Strength
Inactive Ingredients
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Glycerin (UNII: PDC6A3C0OX)
Propylene Glycol (UNII: 6DC9Q167V3)
Water (UNII: 059QF0KO0R)
Sodium Citrate, Unspecified Form (UNII: 1Q73Q2JULR)
Saccharin Sodium (UNII: SB8ZUX40TY)
Sorbitol (UNII: 506T60A25R)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:58407-239-16	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/12/2011	10/25/2013
2	NDC:58407-239-01	15 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/12/2011	10/25/2013

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	10/12/2011	10/25/2013

Labeler - Magna Pharmaceuticals, Inc. (620988360)

Revised: 1/2017

Document Id: e617cd49-2729-4680-8f87-aa44c9826280

Set id: d8eb28a3-08be-461d-862f-feee45640365

Version: 3

Effective Time: 20170112

Magna Pharmaceuticals, Inc.