Sambrosa

Manufacturer
Lelypharma bv
Effective date
2024-08-07
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 00:29:58

Label at a glance#

ProductSambrosa night
Active ingredientDOXYLAMINE SUCCINATE
Label structure13 sections

Indications and 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

Dosage and administration

take only as directed always use the provided measurement spoon. A full spoon equals 3mL. adults and children 12 years of age and over: oral dosage is 3 mL every 4 to 6 hours, not to exceed 18 mL in 24 hours, or as directed by a doctor. children under 12 years of age: consult a doctor.

Storage and handling

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

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Each 3 mL dose contains Doxylamine succinate 9.78 mg

Purpose

OTC - PURPOSE SECTION

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

Uses

INDICATIONS & USAGE SECTION

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

OTC - ASK DOCTOR SECTION

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

OTC - ASK DOCTOR/PHARMACIST SECTION

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

OTC - WHEN USING SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • take only as directed
  • always use the provided measurement spoon. A full spoon equals 3mL.
  • adults and children 12 years of age and over: oral dosage is 3 mL every 4 to 6 hours, not to exceed 18 mL in 24 hours, or as directed by a doctor.
  • children under 12 years of age: consult a doctor.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

STORAGE AND HANDLING SECTION

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

RECENT MAJOR CHANGES SECTION

Directions - 8/2024

PACKAGE LABEL.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.

11

22

33

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2390292doxylamine succinate 9.78 MG in 3 mL Oral SolutionPSN7
2390292doxylamine succinate 3.26 MG/ML Oral SolutionSCD7
2390292doxylamine succinate 9.78 MG per 3 mL Oral SolutionSY7

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DOXYLAMINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80148-001-01Sambrosanight100 mL in 1 BOTTLESYRUP1007
80148-001-01Sambrosanight1 in 1 CARTONSYRUP17
80148-001-02Sambrosanight1 in 1 CARTONSYRUP17
80148-001-02Sambrosanight30 mL in 1 BOTTLESYRUP307
80148-001-03Sambrosanight300 mL in 1 BOTTLESYRUP3007
80148-001-03Sambrosanight1 in 1 CARTONSYRUP17
80148-001-04Sambrosanight3 mL in 1 POUCHSYRUP37

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80148-001SAMBROSA NIGHT (DOXYLAMINE SUCCINATE) SYRUP [LELYPHARMA BV]7Legacy NDC, 7 package rows20241027_adca020a-29e7-ecdd-e053-2a95a90a0b94.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80148-00180148-001-01, 80148-001-03, 80148-001-02, 80148-001-04

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
2553124a-3ebf-365d-e063-6294a90a4224adca020a-29e7-ecdd-e053-2a95a90a0b942024-08-07WarningsExact identifier
spl id: 2553124a-3ebf-365d-e063-6294a90a4224
spl set id: adca020a-29e7-ecdd-e053-2a95a90a0b94

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.