Sambrosa

Manufacturer
Sambrosa Care, Inc. | LGM Pharma Solutions, LLC
Effective date
2026-01-07
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 01:32:43

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 a refrigerator after opening at 35-41 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
  • be careful 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.

Other Information

STORAGE AND HANDLING SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

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 SolutionPSN8
2390292doxylamine succinate 3.26 MG/ML Oral SolutionSCD8
2390292doxylamine succinate 9.78 MG per 3 mL Oral SolutionSY8

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
60665-003-01SambrosaNight100 mL in 1 BOTTLESYRUP1008
60665-003-01SambrosaNight1 in 1 CARTONSYRUP18
60665-003-02SambrosaNight1 in 1 CARTONSYRUP18
60665-003-02SambrosaNight30 mL in 1 BOTTLESYRUP308
60665-003-03SambrosaNight300 mL in 1 BOTTLESYRUP3008
60665-003-03SambrosaNight1 in 1 CARTONSYRUP18
60665-003-04SambrosaNight3 mL in 1 POUCHSYRUP38

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
60665-00360665-003-01, 60665-003-03, 60665-003-02, 60665-003-04

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
Sambrosa NightDOXYLAMINE SUCCINATESambrosa Care, Inc.acdc8740-6231-d1e8-e053-2995a90a3b8d2026-01-07WarningsExact identifier
ndc (package): 60665-003-04
ndc (package): 60665-003-02
ndc (package): 60665-003-03
ndc (package): 60665-003-01
ndc (product): 60665-003
ndc11 (package): 60665000304
ndc11 (package): 60665000303
ndc11 (package): 60665000301
ndc11 (package): 60665000302
spl id: 47ceb0bf-5593-9021-e063-6294a90a4ce1
spl set id: acdc8740-6231-d1e8-e053-2995a90a3b8d

Reported adverse events (FAERS/openFDA)#

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