CHILDRENS COLD AND ALLERGY (BROMPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL) SOLUTION [FAMILY DOLLAR, INC.]

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CHILDRENS COLD AND ALLERGY (BROMPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL) SOLUTION [FAMILY DOLLAR, INC.]
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NDC 55319-994-24
Set ID e13e6e40-fee8-4c33-b561-9bb775f7c896
Category Human OTC Drug Label
Packager Family Dollar, Inc.
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
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  • Drug Facts

    Active ingredients (in each 5 mL (1 tsp) dose )

    Brompheniramine maleate, USP 1 mg
    Phenylephrine HCl, USP 2.5 mg

  • Purposes

    Antihistamine
    Nasal decongestant

  • Uses


    • temporarily relieves 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) (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

    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • trouble urinating due to an enlarged prostate gland
    • glaucoma
    • a breathing problem such as emphysema, asthma, or chronic bronchitis
  • 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
    • drowsiness may occur
    • 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
  • 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 dosage cup provided
    • keep dosage cup with product
    • do not use any other dosing device
    • tsp=teaspoon, mL = milliliter

    Age
    		Dose
     adults and children 12 years and over
    		 20 mL (4 tsp) every 4 hours
     children 6 to under 12 years
    		 10 mL (2 tsp) every 4 hours
     children under 6 years
    		  do not use   

  • Other information

    • each 5 mL contains: sodium 2 mg

    • store at 20-25oC (68-77oF)

    • see bottom panel for lot number and expiration date

  • Inactive ingredients

    Anhydrous citric acid, FD&C Blue No.1, FD&C Red No. 40, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose

    Questions or comments?

    1-855-274-4122

    DISTRIBUTED BY:
    MIDWOOD BRANDS, LLC
    500 VOLVO PARKWAY, CHESAPEAKE, VA 23320

    MADE IN THE USA

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 4 FL OZ (118 mL Bottle)

    COMPARE TO THE ACTIVE INGREDIENTS OF
    CHILDREN'S DIMETAPP® COLD & ALLERGY*

    FAMILY
    WellnessTM


    Children's
    Cold & Allergy
    Each dose (per 5 mL) (1 tsp) of oral solution contains:
    Brompheniramine Maleate, USP 1 mg
    Antihistamine
    Phenylephrine HCl, USP 2.5 mg
    Nasal Decongestant
    Relieves Nasal Symptoms:

    • Stuffy Nose
    • Runny Nose
    • Sneezing

    Plus Other Symptoms:

    • Itchy, Watery Eyes

    GRAPE FLAVOR
    Alcohol Free
    DOSAGE CUP PROVIDED

    For Ages 6 Years & Over
    4 FL OZ (118 mL)     

    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 4 FL OZ (118 mL Bottle)

  • INGREDIENTS AND APPEARANCE
    CHILDRENS COLD AND ALLERGY 
    brompheniramine maleate and phenylephrine hcl solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-994
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BROMPHENIRAMINE MALEATE (UNII: IXA7C9ZN03) (BROMPHENIRAMINE - UNII:H57G17P2FN) BROMPHENIRAMINE MALEATE1 mg  in 5 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GRAPE (UNII: 6X543N684K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorPURPLEScore    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55319-994-241 in 1 CARTON06/10/201604/01/2022
    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 FINALpart34106/10/201604/01/2022
    Labeler - Family Dollar, Inc. (024472631)
    Registrant - Aurohealth LLC (078728447)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aurohealth LLC078728447MANUFACTURE(55319-994)
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