FDA.reportPublic FDA data

Sambrosa

Manufacturer
Sambrosa Care Inc. | BioZone Laboratories, Inc
Effective date
2018-06-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:54:59

Label at a glance#

ProductSambrosa Nighttime
Active ingredientDOXYLAMINE SUCCINATE
Label structure11 sections

Indications and uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose itching of the nose or throat itchy, watery eyes sneezing

Dosage and administration

take only as directed use provided measurement spoon adults and children 12 years of age and over: take 1 spoonful (5 mL) every 4 to 6 hours. do not exceed 7 spoonfuls (35mL) in 24 hours. children under 12 years of age: consult a physician

Storage and handling

store in refrigerator after opening at between 35 and 50 degrees F / 1.7 to 10 degrees C

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Each 5 mL dose contains:



Doxylamine succinate 9.75 mg

Purpose

OTC - PURPOSE SECTION



Doxylamine succinate 9.75 mg.........Antihistamine

Uses

INDICATIONS & USAGE SECTION

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

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

Warnings

WARNINGS SECTION

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

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

Ask a doctor or pharmacist before use if you are taking

OTC - ASK DOCTOR/PHARMACIST SECTION

sedatives or tranquilizers.

When using this product

OTC - WHEN USING SECTION

  • you may get drowsy
  • 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

If pregnant or breast feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

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
  • use provided measurement spoon
  • adults and children 12 years of age and over: take 1 spoonful (5 mL) every 4 to 6 hours. do not exceed 7 spoonfuls (35mL) in 24 hours.
  • children under 12 years of age: consult a physician

Other information

STORAGE AND HANDLING SECTION

  • store in refrigerator after opening at between 35 and 50 degrees F / 1.7 to 10 degrees C

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Alcohol, Aniseed oil, California Poppy Extract, Citric Acid, Eucalyptus Extract, Glycerin, Honey, Hops Extract, Natural Flavor, Passionflower Extract, Potassium Sorbate, Sugar, Thyme Extract, Tragacanth, Water

Questions or comments?

OTC - QUESTIONS SECTION

Call (800) 651-6952

Mon-Fri between 9am and 5 pm PST

DESCRIPTION SECTION

TAMPER EVIDENT: Do not use if printed foil inner seal under bottle cap is broken or missing.

Failure to follow these warnings could result in serious consequences.

Made inthe USA and formulated with a nuique blend of honey and organic herbs combined with active ingredient Doxylamine that relieves allergy symptoms to help you get a good night sleep. Get the nighttime allergy relief you deserve with Sambrosa.

DESCRIPTION SECTION

No High Fructose Corny Syrup

No Artificial Colors or Flavors

Non GMO

Made in the USA

Distributed by

Sambrosa Care

5042 Wilshire Blvd #38242

Los Angeles, CA 90036

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sambrosa

A Healthier Way for Nighttime Allergy Relief

FOR A GOOD NIGHT'S REST

Runny nose

Itchy Eyes & Throat

For a Good Night's Rest

9.75mg Doxylamine Succinate

Antihistamine

Alcohol 5.6%

Base of ​Real Honey​ & ​Organic Herbs​

4 fl oz (118 mL)

Sambrosa Cherry LabelSambrosa Cherry Label

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
60665-00260665-002-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
ANISE OIL6Y89129C8HIACT
ESCHSCHOLZIA CALIFORNICA9315HN272XIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
EUCALYPTUS GLOBULUS LEAFS546YLW6E6IACT
GLYCERINPDC6A3C0OXIACT
HONEYY9H1V576FHIACT
HOPS01G73H6H83IACT
PASSIFLORA INCARNATA FLOWERING TOPCLF5YFS11OIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
SUCROSEC151H8M554IACT
THYMECW657OBU4NIACT
TRAGACANTH2944357O2OIACT
WATER059QF0KO0RIACT
DOXYLAMINE SUCCINATEV9BI9B5YI2ACTIB

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
acddda79-0843-9978-e053-2a95a90a0b5f6dfb6620-c0af-3a34-e053-2a91aa0a95d22020-08-14WarningsExact identifier
spl set id: 6dfb6620-c0af-3a34-e053-2a91aa0a95d2

Reported adverse events (FAERS/openFDA)#

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