Label: SAMBROSA NIGHT- doxylamine succinate syrup

  • NDC Code(s): 80148-001-01, 80148-001-02, 80148-001-03, 80148-001-04
  • Packager: Lelypharma bv
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 30, 2024

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  • Active Ingredients

    Each 3 mL dose contains Doxylamine succinate 9.78 mg

  • Purpose

    Doxylamine succinate 9.78 mg.........Antihistamine

  • Uses

    temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

    • sneezing
    • runny nose
    • itchy, watery eyes
    • itching of the nose or throat
  • Warnings

  • ASK DOCTOR

    Ask a doctor before use if you have

    • glaucoma
    • a breathing problem such as emphysema or chronic bronchitis
    • difficulty urinating due to an enlarged prostate gland
  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before useif you are taking sedatives or tranquilizers.

  • WHEN USING

    When using this product

    • marked drowsiness may occur
    • avoid alcoholic beverages
    • alcohol, sedatives and tranquilizers may increase drowsiness
    • use caution when driving a motor vehicle or operating machinery
    • excitability may occur, especially in children
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast feeding,ask a health professional before use

  • 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.

  • Directions

    • take only as directed
    • use provided measurement spoon, look at calibration marks. A full spoon equals 5 mL.
    • adults and children 12 years of age and over: oral dosage is 7.5 to 12.5 milligrams every 4 to 6 hours, not to exceed 75 milligrams in 24 hours, or as directed by a doctor.
    • children 6 to under 12 years of age: oral dosage is 3.75 to 6.25 milligrams every 4 to 6 hours, not to exceed 37.5 milligrams in 24 hours, or as directed by a doctor.
    • children under 6 years of age: consult a doctor.
  • Inactive Ingredients

    Citric Acid, Glycerin, Herbal alcohol-water extract from 7 organic herbs(California Poppy, Hawthorn, Hops, Mistletoe, Oat, Passion flower, White chestnut) Honey, Potassium Sorbate, Sugar, Tragacanth, Vanilla, and Water.

  • Other Information

    store in refrigerator after opening at between 35 and 41 degrees F (2-5 degrees C)

  • PRINCIPAL DISPLAY PANEL

    sambrosa

    sweet dreams

    Night Syrup

    For allergy relief to have a good night's rest

    With Doxylamine (antihistamine) 9.78 mg

    In a great-tasting base of honey and 7 organic herbs.

    300mL

    10.14 fl oz

    Alcohol 3% vol.

    1

    2

    3

  • INGREDIENTS AND APPEARANCE
    SAMBROSA  NIGHT
    doxylamine succinate syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80148-001
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE9.78 mg  in 3 mL
    Inactive Ingredients
    Ingredient NameStrength
    OAT (UNII: Z6J799EAJK)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SUCROSE (UNII: C151H8M554)  
    TRAGACANTH (UNII: 2944357O2O)  
    ESCHSCHOLZIA CALIFORNICA (UNII: 9315HN272X)  
    AESCULUS HIPPOCASTANUM SEED OIL (UNII: E0M52HIR1Y)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    VANILLA (UNII: Q74T35078H)  
    CRATAEGUS LAEVIGATA FRUIT (UNII: D5RZ7MF1YF)  
    PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    HONEY (UNII: Y9H1V576FH)  
    VISCUM ALBUM FRUITING TOP (UNII: BK9092J5MP)  
    HOPS (UNII: 01G73H6H83)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80148-001-011 in 1 CARTON01/10/2020
    1100 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:80148-001-031 in 1 CARTON01/10/2020
    2300 mL in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:80148-001-021 in 1 CARTON12/01/2020
    330 mL in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:80148-001-043 mL in 1 POUCH; Type 0: Not a Combination Product10/26/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01201/10/2020
    Labeler - Lelypharma bv (408688237)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lelypharma bv408688237manufacture(80148-001)
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