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Optique 1 - Medication Information

Product NDC Code 0220-9277
Drug Name

Optique 1

Type Brand
Pharm Class Increased Large Intestinal Motility [PE],
Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],
Osmotic Activity [MoA],
Osmotic Laxative [EPC],
Potassium Compounds [CS],
Potassium Salt [EPC]
Active Ingredients
Calcium fluoride 10 [hp_x]/ml
Calendula officinalis flowering top 4 [hp_x]/ml
Euphrasia stricta 4 [hp_x]/ml
Jacobaea maritima 6 [hp_c]/ml
Magnesium carbonate 10 [hp_x]/ml
Potassium chloride 10 [hp_x]/ml
Silicon dioxide 10 [hp_x]/ml
Route OPHTHALMIC
Dosage Form LIQUID
Labeler Name Laboratoires Boiron
Packages
Package NDC Code Description
0220-9277-72 30 ml in 1 box (0220-9277-72)
0220-9277-76 10 ml in 1 box (0220-9277-76)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredients** Calcarea fluorica 10X HPUS 0.25% Calendula officinalis 4X HPUS 0.25% Cineraria maritima 6C HPUS 1.50% (contains less than 10 -13 mg pyrrolizidine alkaloids) Euphrasia officinalis 4X HPUS 1.00% Kali Muriaticum 10X HPUS 0.25% Magnesia carbonica 10X HPUS 0.25% Silicea 10X HPUS 0.25% The letters "HPUS" indicate that the component in this product is officially monographed in Homeopathic Pharmacopoeia of the United States.

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 Adults and children 2 years of age and older: At the onset of symptoms, put 1 to 2 drops, or more if necessary, in affected eye(s). Repeat 2 to 6 times a day, as needed, or as directed by a doctor. Children under 2 years of age: Ask a doctor.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
alcohol, 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* temporarily relieves minor irritation such as dry, red, itchy, and burning eyes due to: eyestrain and fatigue light and glare digital displays airborne irritants (pollens and dust)

Purpose

Information about the drug product’s indications for use.
Purpose* Calcarea fluorica 10X HPUS 0.25% ... Relieves eyestrain and fatigue characterized by flickering light Calendula officinalis 4X HPUS 0.25% ... Relieves eye dryness associated with smoke or airborne irritants Cineraria maritima 6C HPUS 1.50% (contains less than 10-13 mg pyrrolizidine alkaloids) ... Soothes sensitivity to light and glare Euphrasia officinalis 4X HPUS 1.00% ...Relieves burning, irritated eyes Kali Muriaticum 10X HPUS 0.25% ... Alleviates gritty sensation (feeling of sand in the eye) Magnesia carbonica 10X HPUS 0.25% ... Relieves sharp and brief eye irritation associated with eye fatigue Silicea 10X HPUS 0.25% ... Relieves tired eyes

Spl product data elements

Usually a list of ingredients in a drug product.
Optique 1 JACOBAEA MARITIMA, EUPHRASIA STRICTA, CALENDULA OFFICINALIS FLOWERING TOP, POTASSIUM CHLORIDE, SILICON DIOXIDE, CALCIUM FLUORIDE, MAGNESIUM CARBONATE WATER SODIUM CHLORIDE JACOBAEA MARITIMA JACOBAEA MARITIMA EUPHRASIA STRICTA EUPHRASIA STRICTA CALENDULA OFFICINALIS FLOWERING TOP CALENDULA OFFICINALIS FLOWERING TOP POTASSIUM CHLORIDE POTASSIUM CATION SILICON DIOXIDE SILICON DIOXIDE CALCIUM FLUORIDE FLUORIDE ION MAGNESIUM CARBONATE CARBONATE ION ALCOHOL

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.
label label box box

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.
Other information do not use if glued carton end flaps are open or if inner foil pouch and droppers are not intact do not refrigerate or freeze after opening foil pouch: store unused droppers in the foul pouch for no longer 3 months at a temperature that does not exceed 77 ° (25°) after opening the dropper: the product must be used immediately after administering discard dropper do not reuse contains 0.00916% alcohol isotonic to tears 1. Tear open the foil pouch at the notched edge. 2. Snap off one single-use dropper. 3. Twist open. 4. Put 1 to 2 drops, or more if necessary in affected eye(s). Sterile Single-Use Dropper Soothing & Refreshing Preservative-Free Eye Irritation Relief* Dry Eyes, Allergies, Eyestrain Soothing & Refreshing Preservative-Free 30 Sterile Single-Use Droppers .013 fl oz (.4 mL) per dropper No-Sting Formula No Vasoconstrictors or Astringents No Rebound Redness No Preservatives * CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVAULATED. ** C, K, CK and X are homeopathic dilutions: see BoironUSA.com/info for details.

Do not use

Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.
Do not use if solution changes color or become cloudy.

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.

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions or comments? Boironusa.com [email protected] 1-800-BOIRON-1 (1-800-264-7661) Distributed by Boiron, Inc. Newtown Square, PA 19073

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 doctor if you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours.

Pregnancy or breast feeding

Pregnancy or Breast feeding
If pregnant or breastfeeding , 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 Obtain immediate medical treatment for all open wounds in or near the eyes. To avoid contamination do not touch tip of dropper to any surface do not touch the eye with the tip of the dropper do not reuse once opened, discard dropper after each use.

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

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