Z-TUSS AC (CHLORPHENIRAMINE MALEATE, CODEINE PHOSPHATE) LIQUID [MAGNA PHARMACEUTICALS, INC.]

Z-TUSS AC (CHLORPHENIRAMINE MALEATE, CODEINE PHOSPHATE) LIQUID [MAGNA PHARMACEUTICALS, INC.]
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NDC 58407-920-10, 58407-920-16
Set ID e61129db-2ee2-4e0c-ab2b-c5f26e62abfc
Category HUMAN OTC DRUG LABEL
Packager Magna Pharmaceuticals, Inc.
Generic Name
Product Class
Product Number
Application Number PART341
  • Drug Facts

    Active ingredients

    (in each 5 mL teaspoonful)

    Chlorpheniramine Maleate 2 mg

    Codeine Phosphate* 9 mg

    *(Warning: May be habit-forming)

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  • Purpose

    Antihistamine

    Antitussive

    (Cough Suppressant)

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  • 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
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  • WARNINGS

    Warnings

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  • ASK DOCTOR

    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
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  • ASK DOCTOR

    Ask a doctor before use if you are

    taking sedatives or tranquilizers

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  • WHEN USING

    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
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  • STOP USE

    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
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  • PREGNANCY OR BREAST FEEDING

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

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  • KEEP OUT OF REACH OF CHILDREN

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

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  • DOSAGE & ADMINISTRATION

    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.

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  • STORAGE AND HANDLING

    Other information

    Store at 15°- 30°C (59°- 86°F)

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  • INACTIVE INGREDIENT

    Inactive ingredients

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

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  • QUESTIONS

    Questions? Comments?

    Call 1-888-206-5525

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  • Z-Tuss AC 473 mL (1 Pint) Label
  • INGREDIENTS AND APPEARANCE
    Z-TUSS  AC
    chlorpheniramine maleate, codeine phosphate liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:58407-920
    Route of Administration ORAL DEA Schedule CV    
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE 2 mg  in 5 mL
    CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J) CODEINE PHOSPHATE 9 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    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     
    Shape Size
    Flavor CHERRY Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:58407-920-16 473 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/11/2011
    2 NDC:58407-920-10 10 mL in 1 BOTTLE; Type 0: Not a Combination Product 09/27/2011 09/30/2013
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 01/11/2011
    Labeler - Magna Pharmaceuticals, Inc. (620988360)
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