Label: ALTICOTRON- dextromethorphan hbr, guaifenesin, phenylephrine hcl solution/ drops

  • NDC Code(s): 53163-107-02
  • Packager: Alternative Pharmacal Corporation
  • Category: HUMAN OTC DRUG LABEL

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 December 23, 2020

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  • ACTIVE INGREDIENT

    Active Ingredients (in each 1 mL)                Purpose

    Dextromethorphan HBr............ 5 mg............. Cough Suppressant

    Guaifenesin.......................... 100 mg............. Expectorant

    Phenylephrine HCl................ 2.5 mg.............. Nasal Decongestant 

  • PURPOSE

    Cough Suppressant

    Expectorant

    Nasal Decongestant

  • INDICATIONS & USAGE

    Uses

    • non-narcotic cough suppreassant which temporarily calms due to minor throat and bronchial irritation as may occur with common cold
    • helps decongest sinus openings and passages; temporarily relieves sinus openings and passages; temporarily relieves sinus congestion and pressur
    • helps lossen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
    • temporarily relieves nasal congestion due to the common cold
    • helps decongest sinus openings and passages; temporarily relieves sinus congestion and pressure
  • WARNINGS

    Warnings

    a persistant cough may be sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor.

    DO NOT USE

    If a child is 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 child's prescription drug that contains MAOI; ask your doctor or pharmacist before taking this product.

    Ask a doctor before use if the child has:

    • Heart disease
    • High blood pressure 
    • Thyroid deases
    • Diabetes
    • Cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or where cough is accompanied by excessive phlegm (mucus)

    When using this product do not exceed recommended dosage.

    Stop use and ask a doctor before use if:

    • your child gets nervous, dizzy, or sleepless
    • symptoms do not get better within 7 days or are accompanied by fever
    • cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
  • PREGNANCY OR BREAST FEEDING

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

  • 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.

  • DOSAGE & ADMINISTRATION

    Directions 

    • Do not use more than 6 doses in any 24 hour period
    • Repeat every 4 hours
    • Measure with dosage device provided. Do not use with any other device
    Children 6 years to under 12 years of age 2 ml 
     Children 2 years to under 6 years of age Ask a doctor
     Children under 2 years of ageAsk a doctor

  • OTHER SAFETY INFORMATION

    Other Information

    Store at room temperature 150 - 300C (590-860F)

    Tamper Evident Feature: Do not use if seal is torn, broken or missing. Avoid excessive heat or humidity.

  • INACTIVE INGREDIENT

    Inactiveingredients

     citric acid, grape flavor, glycerin, methylparaben, polyethylene glycol, propylparaben, purified water, sodium citrate, and sucralose

  • QUESTIONS

    Questions or comments? 1-786-507-1566

  • PRINCIPAL DISPLAY PANEL

    AlticotronAlticotron

  • INGREDIENTS AND APPEARANCE
    ALTICOTRON 
    dextromethorphan hbr, guaifenesin, phenylephrine hcl solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53163-107
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 1 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 1 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53163-107-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product03/01/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34103/01/2015
    Labeler - Alternative Pharmacal Corporation (078528214)