BABY ORAJEL NATURALS FOR TEETHING PAIN RELIEF (CALCAREA PHOSPHORICA, COFFEA CRUDA, CHAMOMILLA) TABLET, ORALLY DISINTEGRATING [CHURCH & DWIGHT CANADA CORP.]

BABY ORAJEL NATURALS FOR TEETHING PAIN RELIEF (CALCAREA PHOSPHORICA, COFFEA CRUDA, CHAMOMILLA) TABLET, ORALLY DISINTEGRATING [CHURCH & DWIGHT CANADA CORP.]
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NDC 62864-903-00, 62864-903-12
Set ID 669db639-3d20-49f8-aa8f-9bbb0c40cafd
Category HUMAN OTC DRUG LABEL
Packager Church & Dwight Canada Corp.
Generic Name
Product Class
Product Number
Application Number
  • Active Ingredient

    Calcarea phosphorica, 3xHPUS
    Coffea Cruda, 3xHPUS
    Chamomilla, 3XHPUS

  • Purpose

    Supports dentition
    Wakefulness and diuresis
    Irritability

  • Uses

    • temporarily relieves the simple symptoms of restlessness and wakeful irritability due to cutting teeth
    • for children under age 2, consult with your physician or pediatrician


       

  • Warnings

    Stop use and ask a doctor if

    • symptoms persist for more than 7 days, if irritation persists, or if inflammation, fever or infection develops
  • Keep out of reach of children.

    In case of overdose or allergic reaction, get medical help or contact a Poison Control Center right away.

  • Directions

    • dissolve 2-3 tablets (1 at a time) under baby's tongue or in a teaspoon of water prior to being given to baby
    • can give 2-3 tablets every hour up to 4 times per day or as recommended by a licensed health care professional
  • Other information

    • do not use if seal is cut or torn prior to opening
  • Inactive Ingredients

    cellulose, lactose, magnesium stearate

  • Questions or comments?

    call us at 1-800-952-5080 M-F 9zm-5pm ET or visit our website at www.orajelnaturals.com

  • Carton Image

    Number 1    TEETHING BRAND
                      used by Pediatricians

    NDC-10237-903-12

                        Baby
                   Orajel

                      Naturals
        for Teething Pain Relief

                                    teething tablets

    HELPS RELIEVE TEETHING DISCOMFORT

    QUICK DISSOLVE         Benzocaine-Free
        TABLETS                    Dye-Free
                                       Alcohol-Free

                    HOMEOPATHIC

    125 TABLETS

    ORAL PAIN RELIEVER FOR TEETHING                              


    Top Carton ImageTop Carton Image

    Bottom Carton ImageBottom Carton Image

  • INGREDIENTS AND APPEARANCE
    BABY ORAJEL NATURALS  FOR TEETHING PAIN RELIEF
    calcarea phosphorica, coffea cruda, chamomilla tablet, orally disintegrating
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62864-903
    Route of AdministrationSUBLINGUAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (CALCIUM CATION - UNII:2M83C4R6ZB) TRIBASIC CALCIUM PHOSPHATE3 [hp_X]
    ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN3 [hp_X]
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA3 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE (UNII: J2B2A4N98G)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize5mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62864-903-001 in 1 CARTON
    1125 in 1 BOTTLE, PLASTIC
    2NDC:62864-903-121 in 1 CARTON
    2125 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic06/15/2011
    Labeler - Church & Dwight Canada Corp. (253933600)
    Registrant - Church & Dwight Co., Inc. (001211952)
    Establishment
    NameAddressID/FEIBusiness Operations
    Church & Dwight Canada Corp.253933600manufacture

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