SAMBROSA NIGHTTIME- doxylamine succinate syrup

Sambrosa by

Drug Labeling and Warnings

Sambrosa by is a Otc medication manufactured, distributed, or labeled by Sambrosa Care Inc., BioZone Laboratories, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Each 5 mL dose contains:



Doxylamine succinate 9.75 mg

Purpose

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

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

Warnings

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 a doctor or pharmacist before use if you are taking

sedatives or tranquilizers.

When using this product

• 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,

ask a health professional before use

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
• 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

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

Inactive Ingredients

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?

Call (800) 651-6952

Mon-Fri between 9am and 5 pm PST

DESCRIPTION

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

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

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)

INGREDIENTS AND APPEARANCE

SAMBROSA  NIGHTTIME
doxylamine succinate syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60665-002
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	9.75 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
ANISE OIL (UNII: 6Y89129C8H)
ESCHSCHOLZIA CALIFORNICA (UNII: 9315HN272X)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)
GLYCERIN (UNII: PDC6A3C0OX)
HONEY (UNII: Y9H1V576FH)
HOPS (UNII: 01G73H6H83)
PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SUCROSE (UNII: C151H8M554)
THYME (UNII: CW657OBU4N)
TRAGACANTH (UNII: 2944357O2O)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60665-002-01	1 in 1 CARTON	06/01/2018
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	06/01/2018

Labeler - Sambrosa Care Inc. (079116527)

Establishment
Name	Address	ID/FEI	Business Operations
BioZone Laboratories, Inc		962455320	manufacture(60665-002)