FDA Label for Sambrosa Night
View Indications, Usage & Precautions
Sambrosa Night Product Label
The following document was submitted to the FDA by the labeler of this product Lelypharma Bv. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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
Otc - 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
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.
Otc - When Using
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
Otc - Pregnancy Or Breast Feeding
If pregnant or breast feeding, ask a health professional before use
Otc - 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 6 years of age and over: take 3mL every 4 to 6 hours. Do not exceed 35mL in 24 hours.
children under 6 years of age: consult a physician
Other Information
store in refrigerator after opening at between 35 and 41 degrees F (2-5 degrees C)
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.
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