Label: CHILDRENS CHEST CONGESTION RELIEF GRAPE- 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 31, 2020

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

  • Drug FactsActive ingredient(in each 5 mL teaspoonful)

    Guaifenesin, USP 100 mg

  • Purpose

    Expectorant

  • Keep out of reach of children

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

  • Uses

    • Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.
  • Warnings

    DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING.

    Ask a doctor before use if the child has:

    • cough that occurs with too much phlegm (mucus)
    • persistant or chronic cough such as occurs with asthma.
  • Stop use and as a doctor if

    • cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistant headache. These could be signs of a serious illness
  • Directions

    • do not use more than 6 doses in any 24-hour period
     age dose
     Children 6 years to under 12 years 1 - 2 teaspoonfuls every 4 hours
     Children 4 years to under 6 years 1/2 - 1 teaspoonful every 4 hours
     Children under 4 years do not use

  • Other information

    • each 5 mL teaspoon contains: sodium 3 mg
    • store at 20°-25°C (68°-77°F)
    • do not refrigerate
    • dosing cup provided
    • Keep carton for full Directions for use.
  • Inactive ingredients

    Anhydrous citric acid, dextrose, FD and C Blue # 1, FD and C Red # 40, flavor, glycerin, maltitol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sucralose, xanthan gum

  • Questions?

    Call weekdays from 9:30 AM to 4:30 PM EST at 1-877-798-5944

  • DISCOUNT drug mart FOOD FAIR Childrens Chest Congestion Relief - Grape

    COMPARE TO THE ACTIVE INGREDIENT IN CHILDREN'S MUCINEX® CHEST CONGESTION

    DISCOUNT

    drug

    mart

    FOOD FAIR

    Children's Chest Congestion Relief

    Guaifenesin Oral Solution, USP

    EXPECTORANT

    Relieves Chest Congestion

    Thins & Loosens Mucus

    Alcohol-Free

    For Ages 4 to 12

    Grape Flavor

    4 FL OZ (118 mL)

    * This product is not manufactured or distributed by Reckitt Benckiser, Inc., distributer of Children's Mucinex®

    SATISFACTION GUARANTEED
    IF DISSASIFIED , RETURN UNUSED PORTION AND PACKAGE TO STORE WHERE PURCHASED. IF UNABLE TO RETURN TO STORE, SEND REASON FOR DISSATISFACTION, NAME, ADDRESS AND EMPTY PACKAGE TO: DISCOUNT DRUG MART, 211 COMMERCE DRIVE, MEDINA, OHIO 44256

    AptaPharma 511 DPL

  • INGREDIENTS AND APPEARANCE
    CHILDRENS CHEST CONGESTION RELIEF GRAPE 
    guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53943-511
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MALTITOL (UNII: D65DG142WK)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    Color    Score    
    ShapeSize
    Flavorgrape (GRAPE) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53943-511-24118 mL in 1 BOTTLE; Type 0: Not a Combination Product02/04/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34102/04/2015
    Labeler - Discount Drug Mart (047741335)