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NDC 60665-0003-03 Sambrosa 9.78 mg/3mL Details
Sambrosa 9.78 mg/3mL
Sambrosa is a ORAL SYRUP in the HUMAN OTC DRUG category. It is labeled and distributed by Sambrosa Care, Inc.. The primary component is DOXYLAMINE SUCCINATE.
MedlinePlus Drug Summary
Doxylamine is used in the short-term treatment of insomnia (difficulty falling asleep or staying asleep). Doxylamine is also used in combination with decongestants and other medications to relieve sneezing, runny nose, and nasal congestion caused by the common cold. Doxylamine should not be used to cause sleepiness in children. Doxylamine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.
Related Packages: 60665-0003-03Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Doxylamine
Product Information
NDC | 60665-0003 |
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Product ID | 60665-003_cf863586-21cb-3bef-e053-2995a90abcbf |
Associated GPIs | |
GCN Sequence Number | n/a |
GCN Sequence Number Description | n/a |
HIC3 | n/a |
HIC3 Description | n/a |
GCN | n/a |
HICL Sequence Number | n/a |
HICL Sequence Number Description | n/a |
Brand/Generic | n/a |
Proprietary Name | Sambrosa |
Proprietary Name Suffix | Night |
Non-Proprietary Name | DOXYLAMINE SUCCINATE |
Product Type | HUMAN OTC DRUG |
Dosage Form | SYRUP |
Route | ORAL |
Active Ingredient Strength | 9.78 |
Active Ingredient Units | mg/3mL |
Substance Name | DOXYLAMINE SUCCINATE |
Labeler Name | Sambrosa Care, Inc. |
Pharmaceutical Class | Antihistamine [EPC], Histamine Receptor Antagonists [MoA] |
DEA Schedule | n/a |
Marketing Category | OTC MONOGRAPH FINAL |
Application Number | part341 |
Listing Certified Through | 2024-12-31 |
Package
Package Images

NDC 60665-0003-03 (60665000303)
NDC Package Code | 60665-003-03 |
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Billing NDC | 60665000303 |
Package | 1 BOTTLE in 1 CARTON (60665-003-03) / 300 mL in 1 BOTTLE |
Marketing Start Date | 2020-01-10 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL acdc8740-6231-d1e8-e053-2995a90a3b8d Details
Uses
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Directions
Other Information
Inactive Ingredients
INGREDIENTS AND APPEARANCE
SAMBROSA
NIGHT
doxylamine succinate syrup |
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Labeler - Sambrosa Care, Inc. (079116527) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
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Lelypharma bv | 408688237 | manufacture(60665-003) |
Revised: 10/2021
Document Id: cf863586-21cb-3bef-e053-2995a90abcbf
Set id: acdc8740-6231-d1e8-e053-2995a90a3b8d
Version: 4
Effective Time: 20211029