Label: ADULT TUSSIN COUGH AND CHEST CONGESTION DM SUGAR FREE- dextromethorphan hbr, guaifenesin 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 December 17, 2019

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  • Active ingredients (in each 10 mL)

    Dextromethorphan HBr 20 mg

    Guaifenesin 200 mg

  • Purposes

    Cough suppressant

    Expectorant

  • Uses

    • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
    • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
  • 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

    • cough that occurs with too much phlegm (mucus)
    • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

    Stop use and ask a doctor if

    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.

    If pregnant or breast-feeding,

    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 (1-800-222-1222) right away.

  • Directions

    • do not take more than 6 doses in any 24-hour period
    • measure only with dosing cup provided. Do not use any other dosing device.
    • keep dosing cup with product
    • mL = milliliter
    • this adult product is not intended for use in children under 12 years of age
    • adult and children 12 years and over: 10 mL every 4 hours
    • children under 12 years: do not use
  • Other information

    • store between 20-25ºC (68-77ºF). Do not refrigerate.
  • Inactive ingredients

    acesulfame potassium, citric acid, flavors, glycerin, methylparaben, polyethylene glycol, povidone, propylene glycol, purified water, saccharin sodium, sodium benzoate

  • Questions or comments?

    Call 1-877-753-3935 Monday-Friday 9AM-5PM EST 

  • Principal Display Panel

    Compare To The Active Ingredients in: Robitussin® Peak Cold Sugar-Free Cough+Chest Congestion DM*

    ADULT

    Tussin

    SUGAR-FREE

    COUGH + CHEST CONGESTION DM

    DEXTROMETHORPHAN HBr 20 mg (Cough Suppressant)

    GUAIFENESIN 200 mg (Expectorant)

    RELIEVES:

    • COUGH
    • MUCUS

    SPECIALLY FORMULATED FOR DIABETICS

    NON-DROWSY

    ALCOHOL- FREE

    FOR AGES 12 & OVER

    Dosage Cup Included

    FL OZ (mL)

    *This product is not manufactured or distributed by Pfizer Consumer Healthcare, distributors of Robitussin® Peak Cold Sugar-Free Cough + Chest Congestion DM.

    TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.

    DISTRIBUTED BY: fred's, Inc.

    4300 NEW GETWELL RD,

    MEMPHIS, TN 38118

    www.fredsinc.com

  • Package Label

    Dextromethorphan HBr 20 mg, Guaifenesin 200 mg

    FRED'S PHARMACY Tussin Sugar-Free Cough + Chest Congestion DM

  • INGREDIENTS AND APPEARANCE
    ADULT TUSSIN COUGH AND CHEST CONGESTION DM  SUGAR FREE
    dextromethorphan hbr, guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55315-817
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 10 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55315-817-041 in 1 BOX06/30/2018
    1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34106/30/2018
    Labeler - Freds Inc (005866116)
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