SAMBROSA SWEET DREAMS NIGHTTIME- doxylamine succinate syrup 
Sambrosa Care Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

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

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, Passionflower Extract, Potassium Sorbate, Sugar, Thyme Extract, Tragacanth, Water

Questions or comments?

Call (800) 651-6952

Mon-Fri between 9am and 5 pm PST

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.

Distributed by

Sambrosa Care,

5042 Wilshire Blvd #38242

Los Angeles, CA 90036

www.sambrosadreams.com

Made in the USA

Sleep is one of life's great pleasures, don't let allergies keep you up at night.

Made in the USA and formualted with a unique blend of honey and organic hebs combined with active ingredieny Doxylamine that relives allergy symptosm to help you get a good night sleep.  Get the nightime alelrgy relief you deserve with Sambrosa.

www.sambrosadreams.com

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

SAMBROSA SWEET DREAMS  NIGHTTIME
doxylamine succinate syrup
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:60665-001
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)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:60665-001-04 1 in 1 CARTON 07/01/2015 06/30/2018
1 118 mL in 1 BOTTLE; Type 0: Not a Combination Product
2 NDC:60665-001-01 5 mL in 1 POUCH; Type 0: Not a Combination Product 07/01/2015 06/30/2018
3 NDC:60665-001-03 3 in 1 PACKAGE 06/30/2017 06/30/2018
3 5 mL in 1 POUCH; 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 07/01/2015 06/30/2018
Labeler - Sambrosa Care Inc. (079116527)
Establishment
Name Address ID/FEI Business Operations
BioZone Laboratories, Inc 962455320 manufacture(60665-001)

Revised: 6/2018
Sambrosa Care Inc.