Label: PEDIACARE CHILDRENS COUGH AND COLD GRAPE- brompheniramine maleate, dextromethorphan hydrobromide, and phenylephrine hydrochloride syrup

  • NDC Code(s): 52412-920-01
  • Packager: RANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTH
  • 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 20, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each 10 ml)Purposes
    Brompheniramine maleate, USP 2 mgAntihistamine
    Dextromethorphan HBr, USP 10 mgCough Suppressant
    Phenylephrine HCl, USP 5 mgNasal decongestant
  • Uses

    • temporarily relieves cough due to minor throat and bronchial irritation occurring with a cold, and nasal congestion due to the common cold, hay fever or other upper respiratory allergies
    • temporarily relieves these symptoms due to hay fever (allergic rhinitis):
      • runny nose
      • sneezing
      • itchy, watery eyes
      • itching of the nose or throat
    • temporarily restores freer breathing through the nose
  • Warnings

    Do not use

    • to sedate a child or to make a child sleepy
    • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certaindrugs 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

    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • trouble urinating due to an enlarged prostate gland
    • glaucoma
    • a cough that occurs with too much phlegm (mucus)
    • a breathing problem or persistent or chronic cough that lasts 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
    • taking sedatives or tranquilizers

    When using this product

    • do not use more than directed
    • may cause marked drowsiness
    • avoid alcoholic beverages
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • be careful when driving a motor vehicle or operating machinery
    • excitability may occur, especially in children

    Stop use and ask a doctor if

    • you get nervous, dizzy, or sleepless
    • 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 right away.

  • Directions

    • do not take more than 6 doses in any 24-hour period
    • measure only with dosage cup provided
    • keep dosing cup with product
    • mL = milliliter
    agedose
    adults and children 12 years and over20 mL every 4 hours
    children 6 to under 12 years10 mL every 4 hours
    children under 6 yearsdo not use
  • Other information

    • store at 20-25°C (68-77°F)
  • Inactive ingredients

    citric acid anhydrous, FD&C blue no. 1, FD&C red no. 40, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose

  • SPL UNCLASSIFIED SECTION

    Distributed by
    CrossingWell Consumer Health
    PO Box 440
    Cornwall, NY 12518

  • PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

    Fast Acting

    Pedia
    Care®

    100% dedicated
    to kids™

    6 Years & Up

    COUGH & COLD

    Relieves:

    • Stuffy, Runny Nose
    • Itchy, Watery Eyes
    • Sneezing
    • Cough

    Brompheniramine maleate - Antihistamine
    (2 mg per 10 mL)

    Phenylephrine HCl - Nasal decongestant
    (5 mg per 10 mL)

    Dextromethorphan HBr - Cough suppressant
    (10 mg per 10 mL)

    Alcohol Free

    Grape Flavor

    4 FL OZ (118 mL)

    PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    PEDIACARE CHILDRENS COUGH AND COLD GRAPE 
    brompheniramine maleate, dextromethorphan hydrobromide, and phenylephrine hydrochloride syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52412-920
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BROMPHENIRAMINE MALEATE (UNII: IXA7C9ZN03) (BROMPHENIRAMINE - UNII:H57G17P2FN) BROMPHENIRAMINE MALEATE2 mg  in 10 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 10 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorPURPLEScore    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52412-920-011 in 1 CARTON01/03/2023
    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 FINALpart34101/03/2023
    Labeler - RANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTH (061995007)
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