Label: BRANTUSSIN DM- dexbrompheniramine maleate, dextromethorphan hbr, phenylephrine hcl liquid

  • NDC Code(s): 71321-700-16
  • Packager: Brandywine Pharmaceuticals, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 8, 2024

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

View All Sections
  • Active Ingredient

    Dexbrompheniramine Maleate 2 mg
    Dextromethorphan Hydrobromide 15 mg
    Phenylephrine Hydrochloride 7.5 mg

  • Uses

    temporarily relieves these symptoms due to the common cold, hayfever (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
    • bronchial irritation
    • nasal congestion
    • reduces swelling of nasal passages
  • Purposes

    Antihistamine

    Cough Suppressant

    Nasal Decongestant

  • Warnings

    Do not exceed recommended dosage.

    Do not use this product

    if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional condition, 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

    • a breathing problem such as emphysema or chronic bronchitis
    • glaucoma
    • trouble urinating due to an enlarged prostate gland
    • a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
    • a cough that occurs with too much phlegm (mucus)
    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes mellitus

    Stop use and ask a doctor if

     nervousness, dizziness, or sleeplessness occur

     cough or nasal congestion 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.

     new symptoms occur

    Keep this and all drugs out of the reach of children

    In case of accidental overdose, get medical help or contact a Poison Control Center immediately.

    When using this product

     excitability may occur, especially in children

     may cause marked drowsiness

     avoid alcoholic drinks
     alcohol, sedatives, and tranquilizers may increase the drowsiness effect

     be careful when driving a motor vehicle or operating machinery

    Ask a doctor or pharmacist before use

    if you are taking sedatives or tranquilizers.

    If pregnant or breastfeeding

    ask a health professional before use.

  • Directions

    Do not exceed recommended dosage

    Adults and children 12 years of age and over1 teaspoonful (5 mL) every 4 to 6 hours, not to exceed 6 teaspoonfuls in 24
    Children 6 to under 12 years of age1/2 teaspoonful (2.5 mL) every 4 to 6 hours, not to exceed 3 teaspoonfuls in 24 hours
    Children under 6 years of ageConsult a doctor.

  • Other Information

    Store at 59° - 86°F (15° - 30°C)

  • Inactive Ingredients

    Anhydrous Citric Acid, Glycerin, Flavor, Propylene Glycol, Purified Water, Sodium Benzoate, Sodium Citrate Dihydrate, Sodium Saccharin, Sorbitol Solution.

  • Questions? Comments?

    Serious side effects associated with use of this product may be reported to this number. Call 1-800-882-1041 Mon. - Fri. (8 a.m. to 5 p.m. CST).

  • Package Label

    Label

  • INGREDIENTS AND APPEARANCE
    BRANTUSSIN DM 
    dexbrompheniramine maleate, dextromethorphan hbr, phenylephrine hcl liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71321-700
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE7.5 mg  in 5 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg  in 5 mL
    DEXBROMPHENIRAMINE MALEATE (UNII: BPA9UT29BS) (DEXBROMPHENIRAMINE - UNII:75T64B71RP) DEXBROMPHENIRAMINE MALEATE2 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SORBITOL (UNII: 506T60A25R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71321-700-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product10/14/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01210/14/2022
    Labeler - Brandywine Pharmaceuticals, LLC (080581956)
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!