Label: MAXI-TUSS AC- codeine phosphate and guaifenesin liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: CV
  • 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 June 23, 2020

If you are a consumer or patient please visit this version.

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each 5 mL = 1 tsp)Purpose
    Codeine phosphate, USP 10 mgAntitussive
    Guaifenesin, USP 100 mgExpectorant
  • Uses

    • temporarily relieves:
      • cough due to minor throat and bronchial irritation as may occur with a cold or inhaled irritants
      • your cough to help you sleep
      • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.
  • Warnings

    Ask your doctor before use if

    • you have a persistent cough, this may be a sign of a serious condition
    • you have a persistent cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
    • you have a cough that is accompanied by excessive phlegm (mucus)
    • you have chronic pulmonary disease or shortness of breath
    • giving to a child who is taking other drugs

    When using this product

    • giving a higher dose than recommended by a doctor could result in serious side effects for your child. A special measuring device should be used to give an accurate dose of this product to children under 6 years of age.
    • may cause or aggravate constipation

    Stop use and ask a doctor if

    • symptoms do not improve within 7 days, tend to recur or are accompanied by fever and rash or persistent headache. These may be symptoms of a serious condition.

    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 6 doses in 24 hours.
    Adults and children 12 years of age and over:2 tsp (10 mL) every 4 hours, or as directed by a doctor.
    Children 6 to under 12 years of age:1 tsp (5 mL) every 4 hours, or as directed by a doctor.
    Children under 6 years of age:Consult a doctor.
  • Other information

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

  • Questions or Comments?

    Call 352.754.8587

  • Inactive ingredients

    Cherry flavor, citric acid, methylparaben, potassium citrate, propylparaben, propylene glycol, purified water, sorbitol, sucralose.

  • PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

    NDC: 58605-313-16

    Maxi-Tuss AC
    Antitussive/Expectorant

    • Sugar Free • Alcohol Free
    • Dye Free • Gluten Free

    Each 5 mL (1 teaspoonful) contains:
    Codeine phosphate, USP 10 mg
    Guaifenesin, USP 100 mg

    Caution: For manufacturing, processing,
    or repackaging. This is a bulk container;
    not intended for household use.

    Tamper evident by
    foil seal under cap.
    Do not use if foil seal
    is broken or missing.

    Manufactured for:
    MCR American Pharmaceuticals, Inc.
    Brooksville, FL 34604

    16 fl. oz. (473 mL)

    PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    MAXI-TUSS AC 
    codeine phosphate and guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58605-313
    Route of AdministrationORALDEA ScheduleCV    
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J) CODEINE PHOSPHATE10 mg  in 5 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Potassium Citrate (UNII: EE90ONI6FF)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    Sorbitol (UNII: 506T60A25R)  
    Sucralose (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58605-313-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34108/01/2020
    Labeler - MCR American Pharmaceuticals, Inc. (783383011)
    Establishment
    NameAddressID/FEIBusiness Operations
    MCR American Pharmaceuticals, Inc.783383011MANUFACTURE(58605-313)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!