NDC Code(s) : 60665-001-04, 60665-001-01, 60665-001-03
Packager : Sambrosa Care Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Sambrosa Sweet Dreams Doxylamine succinate SYRUP
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60665-001
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOXYLAMINE SUCCINATE(UNII: V9BI9B5YI2)
(DOXYLAMINE - UNII:95QB77JKPL) 		DOXYLAMINE SUCCINATE9.75 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)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:60665-001-041 in 1 CARTON 01/07/2015
1118 mL in 1 BOTTLE Type 0: Not a Combination Product
2NDC:60665-001-015 mL in 1 POUCH Type 0: Not a Combination Product01/07/2015
3NDC:60665-001-033 in 1 PACKAGE 30/06/2017
35 mL in 1 POUCH Type 0: Not a Combination Product01/07/2015
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 07/01/2015

PRINCIPAL DISPLAY PANEL

Sambrosa

A healthier Way for Nighttime Allergy Relief

FOR A GOOD NIGHT'S REST

9.75mg  Doxylamine Succinate

Antihistamine

Alcohol 5.6%

Runny nose

Itchy Eyes & Throat

No High Fructose Corn Syrup

No Artificial Colors or Flavors

Non GMO

NIGHTTIME RELIEF

Base of ​Real Honey​ & ​Organic Herbs​


4 fl oz (118 mL)

SambrosaLabel