TUSSIN CF ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI) LIQUID [WESTERN FAMILY FOODS, INC.]

TUSSIN CF ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI) LIQUID [WESTERN FAMILY FOODS, INC.]
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NDC 55312-382-08
Set ID 84f3396d-1623-45dc-9749-848dfb7e7e30
Category HUMAN OTC DRUG LABEL
Packager Western Family Foods, Inc.
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
  • Active ingredients (in each 10 mL)

    Dextromethorphan HBr 20 mg

    Guaifenesin 200 mg

    Phenylephrine HCl 10 mg

  • Purposes

    Cough suppressant

    Expectorant

    Nasal decongestant

  • Uses

    • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
    • temporarily relieves these symptoms occurring with a cold:
      • nasal congestion
      • cough due to minor throat and bronchial irritation
  • 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

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

    Ask a doctor or pharmacist before use if you are

     taking any other oral nasal decongestant or stimulant.

    When using this product,

    do not use more than directed.

    Stop use and ask a doctor if

    • nervousness, dizziness, or sleeplessness occur
    • 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.

    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

    • shake well before using
    • do not take more than 6 doses in any 24-hour period
    • measure only with dosing cup provided
    • 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 20-25°C (68°-77°F). Do not refrigerate.
  • Inactive ingredients

    anhydrous citric acid, FD&C red #40, flavor, glycerin, lactic acid, menthol, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose

  • Questions or comments?

    Call 1-503-639-6300 Monday-Friday 8AM-4PM PST 

  • Principal Display Panel

    Adult 

    TUSSIN CF

    COUGH SUPPRESSANT (DEXTROMETHORPHAN HBr)

    EXPECTORANT (GUAIFENESIN) 

    NASAL DECONGESTANT (PHENYLEPHRINE HCI)

    COUGH & COLD

    NON-DROWSY

    Relieves:

    • Cough
    • STUFFY NOSE CHEST CONGESTION MUCUS

    For Ages 12 & Over

    FL OZ (mL)

    Gluten Free

    COMPARE TO ROBITUSSIN® Peak Cold Multi-Symptom Cold CF active ingredients*

    *This product is not manufactured or distributed by Pfizer Consumer Healthcare, distributors of Robitussin® Peak Cold Multi-Symptom Cold CF.

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

    Proudly Distributed by Western Family, Inc.

    P.O. Box 4057, Portland, OR 97208 USA

    www.westernfamily.com

  • Package Label

    Dextromethorphen HBr 20 mg Guaifenesin 200 mg Phenylephrine HCI 10 mg

    Western Family Tussin CF

  • INGREDIENTS AND APPEARANCE
    TUSSIN CF  ADULT
    dextromethorphan hbr, guaifenesin, phenylephrine hci liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55312-382
    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
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    MENTHOL (UNII: L7T10EIP3A)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55312-382-081 in 1 BOX08/31/201512/31/2021
    1237 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 FINALpart34108/31/201512/31/2021
    Labeler - Western Family Foods, Inc. (192166072)

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