Label: ABATUSS DMX- dexchlorpheniramine maleate, dextromethorphan hydrobromide, pseudoephedrine hydrochloride liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 Label Information

Updated November 26, 2018

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  • Drug Facts
  • Active ingredients (per 5 mL )

    Dexchlorpheniramine Maleate 1 mg
    Dextromethorphan HBr  15 mg
    Pseudoephedrine HCl 30 mg

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  • Purpose

    Antihistamine
    Cough Suppressant
    Nasal Decongestant

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  • Uses

    temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

    • sneezing
    • itchy nose or throat
    • runny nose
    • itchy, watery eyes
    • nasal congestion
    • temporarily controls cough due to minor throat and bronchial irritation associated with inhaled irritants
    • temporarily restores freer breathing through nose
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  • Warnings

    Do not use if you are 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

    Ask a doctor before use if you have

    • heart disease • high blood pressure • thyroid disease • diabetes • a breathing problem such as emphysema or chronic bronchitis • glaucoma • difficulty in urination due to enlarged prostate gland • persistent or chronic  cough such as occurs with smoking, asthma, or emphysema • cough accompanied by excessive phlegm (mucus)

    Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

    When using this product • do not exceed recommended dosage  • may cause drowsiness  • alcohol, sedatives, and tranquilizers may increase the drowsiness effect • avoid alcoholic beverages   • use caution when driving a motor vehicle or operating machinery marked may occur • excitability may occur especially in children

    Stop use and ask a doctor if 
    • nervousness, dizziness, or sleeplessness occur  • cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition. • symptoms do not improve within 7 days or are accompanied by fever

    If pregnant or breastfeeding 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.

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  • Directions:

     Adults and children 12 years of age and older 2 teaspoonfuls (10 mL) every 6 hours, not to exceed 8 teaspoonfuls in 24 hours or as directed by a doctor
     Children 6 to under 12 years of age 1 teaspoonful (5 mL) every 6 hours, not to exceed 4 teaspoonfuls in 24 hours or as directed by a doctor
     Children 2 to under 6 years of age  Consult a doctor

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  • Other information

    • Store at controlled room temperature 15°C-30°C (59°F-86°F)
    • Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing
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  • Inactive ingredients:

    Citric acid, FD&C blue #1, FD&C Red #40, grape flavor, methylparaben, monoammonium glycyrrhizinate, potassium citrate, potassium sorbate, propylene glycol, propylparaben, purified water, sorbitol, sucralose.

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  • SPL UNCLASSIFIED SECTION

    *Contains the same active ingredients as Deltuss DMX®

    Antihistamine
    Cough Suppressant
    Nasal Decongestant

    Each 5 mL contains:

    Dexchlorpheniramine Maleate ...................1 mg
    Dextromethorphan HBr.............................15 mg
    Pseudoephedrine HCl ...............................30 mg

    • Alcohol Free  • Sugar Free

    • Gluten Free

    Grape Flavor

    Manufactured in the USA for Kramer Novis, San Juan, PR 00917. T: (787) 767-2072 www.kramernovis.com

    * Deltuss DMX® is a registered trademark of Deliz Pharmaceutical Corp. This product is not manufactured, distributed or marketed by Deliz Pharmaceutical Corp.

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  • Packaging
  • INGREDIENTS AND APPEARANCE
    ABATUSS DMX 
    dexchlorpheniramine maleate, dextromethorphan hydrobromide, pseudoephedrine hydrochloride liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:52083-625
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DEXCHLORPHENIRAMINE MALEATE (UNII: B10YD955QW) (DEXCHLORPHENIRAMINE - UNII:3Q9Q0B929N) DEXCHLORPHENIRAMINE MALEATE 1 mg  in 5 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 15 mg  in 5 mL
    PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
    POTASSIUM CITRATE (UNII: EE90ONI6FF)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor GRAPE (Grape Flavor) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52083-625-16 1 in 1 CARTON 05/25/2014
    1 473 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 05/25/2014
    Labeler - Kramer Novis (090158395)
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