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| Product NDC Code | 80148-001 | ||||||||||
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| Drug Name | Sambrosa night |
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| Type | Brand | ||||||||||
| Pharm Class | Antihistamine [EPC], Histamine Receptor Antagonists [MoA] |
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| Active Ingredients |
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| Route | ORAL | ||||||||||
| Dosage Form | SYRUP | ||||||||||
| RxCUI drug identifier | 2390292 | ||||||||||
| Application Number | M012 | ||||||||||
| Labeler Name | Lelypharma bv | ||||||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Each 3 mL dose contains Doxylamine succinate 9.78 mg
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions take only as directed always use the provided measurement spoon. A full spoon equals 3mL. adults and children 12 years of age and over: oral dosage is 3 mL every 4 to 6 hours, not to exceed 18 mL in 24 hours, or as directed by a doctor. children under 12 years of age: consult a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.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.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.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
Purpose
Information about the drug product’s indications for use.Purpose Doxylamine succinate 9.78 mg.........Antihistamine
Spl product data elements
Usually a list of ingredients in a drug product.Sambrosa night DOXYLAMINE SUCCINATE OAT WATER GLYCERIN SUCROSE TRAGACANTH ESCHSCHOLZIA CALIFORNICA AESCULUS HIPPOCASTANUM SEED OIL POTASSIUM SORBATE VANILLA CRATAEGUS LAEVIGATA FRUIT PASSIFLORA INCARNATA FLOWERING TOP CITRIC ACID MONOHYDRATE HONEY VISCUM ALBUM FRUITING TOP HOPS DOXYLAMINE SUCCINATE DOXYLAMINE
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.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
Recent major changes
A list of the section(s) that contain substantive changes that have been approved by FDA in the product labeling. The headings and subheadings, if appropriate, affected by the change are listed together with each section’s identifying number and the month and year on which the change was incorporated in the labeling.Directions - 8/2024
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.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 or pharmacist
Information about when a doctor or pharmacist should be consulted about drug/drug or drug/food interactions before using a drug product.Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product marked drowsiness may occur 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
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast feeding, ask a health professional before use
Storage and handling
Information about safe storage and handling of the drug product.Other Information store in refrigerator after opening at between 35 and 41 degrees F (2-5 degrees C)
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API