Label: DRX CHOICE FRUIT PUNCH- guaifenesin syrup

  • NDC Code(s): 68163-743-04
  • Packager: Raritan Pharmaceuticals 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 September 2, 2023

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  • Active ingredient (in each 10 mL)

    Guaifenesin, USP 200 mg

  • Purpose

    Expectorant

  • Use

    helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

  • Warnings

    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 for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign 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 right away at (1-800-222-1222).

  • Directions

    •
    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

    age

    dose

    adults and children 12 years and over

    10 – 20 mL every 4 hours

    children under 12 years

    do not use
  • Other information

    •
    each 10 mL contains: sodium 4 mg
    •
    store at room temperature
  • Inactive ingredients

    anhydrous citric acid, disodium edetate, FD&C red no. 40, flavor, potassium citrate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum.

  • Principal Display Panel

    DRx CHOICE®

    NDC# 68163-743-04

    Compare to the active ingredient in Robitussin® Mucus + Chest Congestion*

    Adult Cough Syrup

    Guaifenesin (Expectorant)

    Relieves:

    •
    Mucus
    •
    Chest congestion

    Sugar-Free

    ORIGINAL

    Fruit Punch Flavor

    Naturally and Artificially Flavored

    For Ages 12 & Over

    4 FL OZ (118 mL)

    IMPORTANT: Keep this carton for future reference on full labeling.

    *This product is not manufactured or distributed by Pfizer, owner of the registered trademark Robitussin® Mucus + Chest Congestion.

    Manufactured by:

    Raritan Pharmaceuticals

    8 Joanna Court,

    East Brunswick, NJ 08816

    DRx Choice Adult Cough Syrup Fruit Punch Flavor
  • INGREDIENTS AND APPEARANCE
    DRX CHOICE  FRUIT PUNCH
    guaifenesin syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68163-743
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    POTASSIUM CITRATE (UNII: EE90ONI6FF)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorREDScore    
    ShapeSize
    FlavorFRUIT PUNCH (Naturally and Artificially) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68163-743-041 in 1 CARTON05/15/2019
    1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34105/15/2019
    Labeler - Raritan Pharmaceuticals Inc (127602287)
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