BABY ORAJEL NATURALS (CALCERIA CARBONICA, CALCERIA PHOSPHORICA, CHAMOMILLA, COFFEA CRUDA, PASSIFLORA INCARNATA, TEREBINTHINA) TABLET, ORALLY DISINTEGRATING [CHURCH & DWIGHT CO., INC.]

BABY ORAJEL NATURALS (CALCERIA CARBONICA, CALCERIA PHOSPHORICA, CHAMOMILLA, COFFEA CRUDA, PASSIFLORA INCARNATA, TEREBINTHINA) TABLET, ORALLY DISINTEGRATING [CHURCH & DWIGHT CO., INC.]
PDF | XML

NDC 10237-908-12
Set ID 26545e80-8c0c-2424-e054-00144ff88e88
Category HUMAN OTC DRUG LABEL
Packager Church & Dwight Co., Inc.
Generic Name
Product Class
Product Number
Application Number
  • ACTIVE INGREDIENT

    Calcarea carbonica, Calcarea phosphorica, Chamomilla, Coffea cruda, Passiflora incarnata (Passion Flower), Terebinthina

  • PURPOSE

    Calcarea carbonica - Delayed or slow teething

    Calcarea phosphorica - Difficult teething, dentition

    Chamomilla - Irritibility, crying and whining

    Coffea cruda - Occassional sleeplessness, restlessness

    Passiflora incarnata - Restlessness

    Terebinthia - Irritability

  • INDICATIONS & USAGE

    Uses

    Temporarily relieves the multiple symptoms of dentition, restlessness and wakeful irritability due to cutting teeth. For children under 2, consult your physician or healthcare provider.

  • WARNINGS

    WARNINGS

    Stop use and ask a doctor if symptoms persist for more than 7 days, if irritation persists of if inflammation, fever or infection develops.

  • KEEP OUT OF REACH OF CHILDREN

    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 healthcare professional.

    Other information

    Do not use if seal is cut or torn prior to opening

    Store in dry environment

    Leave SorbiCap desiccant in bottle

  • INACTIVE INGREDIENT

    Cellulose, lactose, magnesium stearate, mannitol, starch

  • QUESTIONS

    Questions or comments. Call us at 800 952 5080 or visit www orajel com

  • PRINCIPAL DISPLAY PANEL

    #1 TEETHING BRAND

    recommended by Pediatricians

    La marca numero 1

    para la denticion

    mas recomendada

    por pediatras

    Fast Dissolving

    Baby

    Orajel

    Naturals

    for Teething Pain Relief

    Para el alivio del dolor de las denticion

    HOMEOPATHIC Homeopatico

    MULTI-SYMPTOM TEETHING RELIEF

    Multiples sintomas

    • Teething Discomfort Molestia de la denticion
    • Restlessness & Irritability Inquietud e irritabilidad
    • First Tooth Development Aparicion de los primeros dientes

    ORAL PAIN RELIEVER FOR TEETHING

    Analgesico Oral Para La Denticion

    135 TABLETS

    Tabletas

    BOJFC-32371-06

    BOJFC-32371-06

  • INGREDIENTS AND APPEARANCE
    BABY ORAJEL NATURALS 
    calceria carbonica, calceria phosphorica, chamomilla, coffea cruda, passiflora incarnata, terebinthina tablet, orally disintegrating
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-908
    Route of AdministrationSUBLINGUAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA FLOWERING TOP6   in 1 [hp_X]
    TURPENTINE OIL (UNII: C5H0QJ6V7F) (TURPENTINE OIL - UNII:C5H0QJ6V7F) TURPENTINE OIL7   in 1 [hp_X]
    OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE12   in 1 [hp_X]
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA6   in 1 [hp_X]
    ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN6   in 1 [hp_X]
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION12   in 1 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    LACTOSE (UNII: J2B2A4N98G)  
    MANNITOL (UNII: 3OWL53L36A)  
    Product Characteristics
    ColorwhiteScorescore with uneven pieces
    ShapeROUNDSize5mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10237-908-121 in 1 CARTON
    1135 [hp_X] in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/18/2016
    Labeler - Church & Dwight Co., Inc. (001211952)
    Establishment
    NameAddressID/FEIBusiness Operations
    Church & Dwight Canada Corp.253933600manufacture(10237-908)

Related Drugs