SAMBROSA NIGHT- doxylamine succinate syrup 
Lelypharma bv

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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:

Warnings

Ask a doctor before use if you have

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

When using this product

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

Inactive Ingredients

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

Other Information

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

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.

1

2

3

SAMBROSA  NIGHT
doxylamine succinate syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80148-001
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE9.78 mg  in 3 mL
Inactive Ingredients
Ingredient NameStrength
OAT (UNII: Z6J799EAJK)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
SUCROSE (UNII: C151H8M554)  
TRAGACANTH (UNII: 2944357O2O)  
ESCHSCHOLZIA CALIFORNICA (UNII: 9315HN272X)  
AESCULUS HIPPOCASTANUM SEED OIL (UNII: E0M52HIR1Y)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
VANILLA (UNII: Q74T35078H)  
CRATAEGUS LAEVIGATA FRUIT (UNII: D5RZ7MF1YF)  
PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
HONEY (UNII: Y9H1V576FH)  
VISCUM ALBUM FRUITING TOP (UNII: BK9092J5MP)  
HOPS (UNII: 01G73H6H83)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80148-001-011 in 1 CARTON01/10/2020
1100 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:80148-001-031 in 1 CARTON01/10/2020
2300 mL in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:80148-001-021 in 1 CARTON12/01/2020
330 mL in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:80148-001-043 mL in 1 POUCH; Type 0: Not a Combination Product10/26/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01201/10/2020
Labeler - Lelypharma bv (408688237)
Establishment
NameAddressID/FEIBusiness Operations
Lelypharma bv408688237manufacture(80148-001)

Revised: 4/2024
Document Id: 1758c9f4-d2ab-2bb6-e063-6394a90a09cf
Set id: adca020a-29e7-ecdd-e053-2a95a90a0b94
Version: 6
Effective Time: 20240430
 
Lelypharma bv