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| Product NDC Code | 76328-100 | ||||
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| Drug Name | Ancient secrets breathe again |
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| Type | Brand | ||||
| Pharm Class | Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC] |
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| Active Ingredients |
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| Route | NASAL | ||||
| Dosage Form | AEROSOL, SPRAY | ||||
| RxCUI drug identifier | 1146022 | ||||
| Application Number | part349 | ||||
| Labeler Name | LOTUS BRANDS, INC. | ||||
| 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 ingredient Sodium Chloride 2.0% (Seawater-derived)
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 Tilt head to one side and forward. Holding can parallel to the nose, insert nozzle into upper nostril. Press valve briefly for release of fine mist. Repeat 2-3 times on each nostril as needed. Use 2-4 times daily, or as often as necessary. Use with children ages 6 and older. Wash carefully with clean warm water and dry carefully after each use.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients purified 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 for nasal rinsing in adults: Moisturizes and cleanses nasal passages due to pollution, dry air, air conditioning, dust, pollen Nasal drainage Helps dry congestion due to colds and allergies
Purpose
Information about the drug product’s indications for use.Purpose Restores Moisture
Spl product data elements
Usually a list of ingredients in a drug product.Ancient Secrets Breathe Again Sodium Chloride Sodium Chloride Sodium Cation Water
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.PRINCIPAL DISPLAY PANEL - 100 mL Bottle Carton ANCIENT SECRETS ® Breathe Again™ Hypertonic Seawater Nasal Spray Sterilized Helps Dry Congestion Due to Colds and Allergies Preservative-Free Saline 3.38 fl.oz. (100 mL) Principal Display Panel - 100 mL Bottle Carton
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
Manufactured by Gerolymatos International S.A. Athens, Greece ®©2011, Distributed by Lotus Brands, Inc., A majority woman-owned family business 1100 Lotus Drive, Silver Lake, WI 53170, USA
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 the reach of children.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions, Comments, Side Effects? Call toll free 800-824-6396, Monday – Friday, 9:00 – 5:00, CST
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if you experience any discomfort while using this product.
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 To avoid contamination, do not touch tip of the dispenser to any surface. Do not use the same dispenser on different people.
Storage and handling
Information about safe storage and handling of the drug product.Other Information Avoid spraying in eyes. Contents under pressure. Do not puncture or incinerate. Store at room temperature (59-86°F).
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 For nasal use only. When using this product To avoid contamination, do not touch tip of the dispenser to any surface. Do not use the same dispenser on different people. Stop use and ask a doctor if you experience any discomfort while using this product. Keep out of the reach of children.
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