SAMBROSA NIGHT- doxylamine succinate syrup

Sambrosa by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active Ingredients

Each 3 mL dose contains Doxylamine succinate 9.78 mg

Purpose

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

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

Warnings

ASK DOCTOR

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 DOCTOR/PHARMACIST

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

WHEN USING

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

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

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, look at calibration marks. A full spoon equals 5 mL.
• adults and children 12 years of age and over: oral dosage is 7.5 to 12.5 milligrams every 4 to 6 hours, not to exceed 75 milligrams in 24 hours, or as directed by a doctor
• children 6 to under 12 years of age: oral dosage is 3.75 to 6.25 milligrams every 4 to 6 hours, not to exceed 37.5 milligrams in 24 hours, or as directed by a doctor
• children under 6 years of age: consult a physician

Other Information

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

Inactive Ingredients

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.

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.

INGREDIENTS AND APPEARANCE

SAMBROSA  NIGHT
doxylamine succinate syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60665-003
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	9.78 mg  in 3 mL

Inactive Ingredients
Ingredient Name	Strength
CRATAEGUS LAEVIGATA FRUIT (UNII: D5RZ7MF1YF)
OAT (UNII: Z6J799EAJK)
WATER (UNII: 059QF0KO0R)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O)
SUCROSE (UNII: C151H8M554)
AESCULUS HIPPOCASTANUM SEED OIL (UNII: E0M52HIR1Y)
HONEY (UNII: Y9H1V576FH)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
TRAGACANTH (UNII: 2944357O2O)
VANILLA (UNII: Q74T35078H)
VISCUM ALBUM FRUITING TOP (UNII: BK9092J5MP)
ESCHSCHOLZIA CALIFORNICA (UNII: 9315HN272X)
HOPS (UNII: 01G73H6H83)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60665-003-01	1 in 1 CARTON	01/10/2020
1		100 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 60665-003-03	1 in 1 CARTON	01/10/2020
2		300 mL in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 60665-003-02	1 in 1 CARTON	12/01/2020
3		30 mL in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC: 60665-003-04	3 mL in 1 POUCH; Type 0: Not a Combination Product	10/26/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	01/10/2020

Labeler - Sambrosa Care, Inc. (079116527)

Establishment
Name	Address	ID/FEI	Business Operations
Lelypharma bv		408688237	manufacture(60665-003)