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Sinus relief - Prescription Drug Labeling

Product NDC Code 59262-240
Drug Name

Sinus relief

Type Brand
Active Ingredients
Potassium dichromate 6 [hp_x]/20ml
Luffa operculata fruit 6 [hp_x]/20ml
Schoenocaulon officinale seed 6 [hp_x]/20ml
Route NASAL
Dosage Form SPRAY
Labeler Name Similasan Corporation
Packages
Package NDC Code Description
59262-240-20 20 ml in 1 bottle, spray (59262-240-20)

Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient Kali bichromicum 6X Active Ingredient Luffa operculata 6X Active Ingredient Sabadilla 6X

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: For adults and children ages 2 and over: Remove tamper-evident plastic seal from bottle. Lift cap off bottle. Spray 1-3 times into each nostril. Use as needed. Replace cap after use.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive Ingredients: Purified water, Sodium chloride

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*: According to homeopathic principles, the active ingredients in this product temporarily relieve minor symptoms such as: Runny nose due to colds Sinus pressure Nasal congestion Post-nasal drip Irritating dryness of nasal passages

Purpose

Information about the drug product’s indications for use.
Purpose sinus congestion, runny nose, sinus pressure, nasal dryness Purpose runny nose, nasal dryness, sinus congestion Purpose sneezing, itching

Spl product data elements

Usually a list of ingredients in a drug product.
Sinus Relief Kali bichromicum, Luffa operculata, Sabadilla POTASSIUM DICHROMATE DICHROMATE ION LUFFA OPERCULATA FRUIT LUFFA OPERCULATA FRUIT SCHOENOCAULON OFFICINALE SEED SCHOENOCAULON OFFICINALE SEED WATER SODIUM CHLORIDE

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 Similasan Sinus Relief NASAL MIST PRESERVATIVE FREE NON-HABIT FORMING 20 ml / 0.68 fl oz Similasan Sinus Relief NASAL MIST PRESERVATIVE FREE NON-HABIT FORMING 20 ml / 0.68 fl oz Similasan Sinus Relief NASAL MIST PRESERVATIVE FREE NON-HABIT FORMING 20 ml / 0.68 fl oz

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

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: Are susceptible to nose bleeds. Are prone to ear, nose, or throat sensitivity.

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. If swallowed, get medical help or contact a Poison Control Center right away.

Other safety information

Information about safe use and handling of the product that may not have been specified in another field.
Other information: Active ingredients are manufactured according to homeopathic principles.

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions? Reach our representatives 1-800-240-9780 or [email protected] www.SimilasanUSA.com

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: Symptoms worsen or persist for more than 72 hours

Pregnancy or breast feeding

Pregnancy or Breast feeding
If pregnant, trying to get pregnant or breast feeding, ask a health professional before use.

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: According to homeopathic principles, symptoms may temporarily worsen before improving (Initial exacerbation of symptoms). Replace cap tightly after every use. To avoid contamination, do not touch the tip of the container to any surface besides nose. Discard open bottle after 6 months. The use of this container by more than one person may spread infection. If pregnant, trying to get pregnant or breast feeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Ask a doctor before use if you: Are susceptible to nose bleeds. Are prone to ear, nose, or throat sensitivity. Stop use and ask a doctor if: Symptoms worsen or persist for more than 72 hours

Disclaimer: Do not rely on openFDA 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

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