Label: BERRO Y CEBOLLA DM- dextromethorphan hydrobromide, guaifenesin liquid

  • NDC Code(s): 53145-080-08
  • Packager: Menper Distributors, Inc.
  • 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 January 23, 2020

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

  • Active Ingredients in each 15mL

    Dextromethorphan HBr - 10mg

    Guaifenesin - 100mg

  • Purpose

    Cough Suppressant

    Expectorant

  • Uses

    - temporarily relieves cough as may occur with the common cold

    - helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus

  • Do not exceed recommended dosage

    Do not use

    if you are now taking a prescription monamine 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

    a persistent or chronic cough
    a cough that is accompanied by excessive phlegm (mucus)
    a breathing problem such as occurs with smoking, asthma, chronic bronchitis, or emphysema

  • 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
    • nervousness, dizziness, or sleeplessness occurs
  • If pregnant or breast-feeding 

    ask a health professional before use.

  • Keep out of reach of children.

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

  • Directions

    shake well before use
    do not exceed more than 6 doses in any 24-hour period or as directed by a doctor.

    AGE                                                                                       Dose
    adults and children 12 years of age and over                             2 tablespoons (30 mL) every 4 hours
    children 6 to under 12 years of age                                           1 tablespoon (15 mL) every 4 hours
    children under 6 years of age                                                   consult a doctor

  • Other information

    store between 15° - 30° C (59° - 86° F)

    Tamper-Evident Feature: Do not use this product if printed safety seal over cap is torn, broken or missing.

  • Inactive ingredients

    Aloe leaf extract, ascorbic acid, cat's claw bark extract, corn syrup, DATEM, ethyl alcohol (0.15%), eucalyptus, FD&C blue #1, FD&C yellow #5, garlic bulb extract, ginger root extract, gum arabic, honey, menthol, methylparaben, onion bulb fluid extract, peppermint leaf fluid extract, polysorbate 80, potassium sorbate, propylene glycol, propylparaben, sodium benzoate, sucralose, sunflower oil, water.

  • Questions or Comments?

    1-800-560-5223 M-F 9 AM to 4 PM Eastern

  • PRINCIPAL DISPLAY PANEL

    Berro y cebolla DM

  • INGREDIENTS AND APPEARANCE
    BERRO Y CEBOLLA  DM
    dextromethorphan hydrobromide, guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53145-080
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 15 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 15 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE (UNII: V5VD430YW9)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    CAT'S CLAW (UNII: 9060PRM18Q)  
    CORN SYRUP (UNII: 9G5L16BK6N)  
    DIACETYLTARTARIC AND FATTY ACID ESTERS OF GLYCEROL (UNII: 248HN3Z28U)  
    ALCOHOL (UNII: 3K9958V90M)  
    EUCALYPTUS ALBA LEAF (UNII: 2JEJ1KEK9A)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    GARLIC (UNII: V1V998DC17)  
    GINGER (UNII: C5529G5JPQ)  
    ACACIA (UNII: 5C5403N26O)  
    HONEY (UNII: Y9H1V576FH)  
    MENTHOL (UNII: L7T10EIP3A)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ONION (UNII: 492225Q21H)  
    PEPPERMINT (UNII: V95R5KMY2B)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53145-080-081 in 1 CARTON04/01/2019
    1237 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34104/01/2019
    Labeler - Menper Distributors, Inc. (101947166)