Z-TUSS AC- chlorpheniramine maleate, codeine phosphate 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 AC

Drug Facts

Active ingredients

(in each 5 mL teaspoonful)

Chlorpheniramine Maleate 2 mg

Codeine Phosphate* 9 mg

*(Warning: May be habit-forming)

Purpose

Antihistamine

Antitussive

(Cough Suppressant)

Uses

temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:

  • runny nose
  • sneezing
  • itching of the nose or throat
  • itchy, watery eyes
  • cough due to minor throat and minor bronchial irritation

Warnings

Ask a doctor before use if you have

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland
  • a persistent or chronic cough such as occurs with smoking, asthma or emphysema
  • a cough that occurs with too much phlegm (mucus)
  • a chronic pulmonary disease, shortness of breath, or children who are taking other drugs

Ask a doctor before use if you are

taking sedatives or tranquilizers

When using the product

  • excitability may occur, especially in children
  • may cause marked drowsiness
  • avoid alcoholic beverages
  • alcohol, sedatives, and tranquilizers may increase the drowsiness effect
  • be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

  • cough 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
  • may cause or aggravate constipation

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

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

Do not exceed recommended dosage.

Adults and Children

12 years of age and

over:

2 teaspoonfuls (10 mL)

every 4-6 hours, not to

exceed 12 teaspoonfuls

in a 24 hour period.

Children 6 to under

12 years of age:

1 teaspoonful (5 mL)

every 4-6 hours, not to

exceed 6 teaspoonfuls

in a 24 hour period.

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 effects for your child.

Other information

Store at 15°- 30°C (59°- 86°F)

Inactive ingredients

Cherry Flavor, Citric Acid, FD&C Red No. 40, Glycerin, Propylene Glycol, Purified Water, Sodium Citate, Sodium Saccharin, Sorbitol.

Questions? Comments?

Call 1-888-206-5525

Z-Tuss AC 118mL

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Z-TUSS  AC
chlorpheniramine maleate, codeine phosphate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58407-920
Route of AdministrationORALDEA ScheduleCV    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE2 mg  in 5 mL
CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J) CODEINE PHOSPHATE9 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58407-920-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product01/11/201109/01/2019
2NDC:58407-920-1010 mL in 1 BOTTLE; Type 0: Not a Combination Product09/27/201109/30/2013
3NDC:58407-920-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/201912/31/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/11/201112/31/2020
Labeler - Magna Pharmaceuticals, Inc. (620988360)
Establishment
NameAddressID/FEIBusiness Operations
Woodfield Pharmaceuticals, LLC079398730manufacture(58407-920)

Revised: 10/2020
Document Id: b244aa71-b60b-31b8-e053-2995a90a0515
Set id: e61129db-2ee2-4e0c-ab2b-c5f26e62abfc
Version: 7
Effective Time: 20201022
 
Magna Pharmaceuticals, Inc.