DOSAGE & ADMINISTRATION SECTION.
Directions. Adults and children years of age and older: Put drop in the affected eye(s) twice daily, every to 12 hours, no more than twice per day.Children under years of age: Consult doctor.. Adults and children years of age and older: Put drop in the affected eye(s) twice daily, every to 12 hours, no more than twice per day.. Children under years of age: Consult doctor.
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INACTIVE INGREDIENT SECTION.
Inactive ingredients. Benzalkonium Chloride 0.01%, Glycerin, Water for Injection.May contain Hydrochloric Acid and/or Sodium Hydroxide to adjust pH.
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INDICATIONS & USAGE SECTION.
Use. Temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander.
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OTHER SAFETY INFORMATION.
Other information. only for use in the eye.store at 20 to 25C (68 to 77F) [see USP Controlled Room Temperature].. only for use in the eye.. store at 20 to 25C (68 to 77F) [see USP Controlled Room Temperature].
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OTC - ACTIVE INGREDIENT SECTION.
Active ingredient. Ketotifen (0.025%)(equivalent to ketotifen fumarate 0.035%).
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OTC - DO NOT USE SECTION.
Do not use. if solution changes color or becomes cloudyif you are sensitive to any ingredient in this productto treat contact lens related irritation. if solution changes color or becomes cloudy. if you are sensitive to any ingredient in this product. to treat contact lens related irritation.
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OTC - KEEP OUT OF REACH OF CHILDREN SECTION.
Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away. (1-800-222-1222).
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OTC - PURPOSE SECTION.
Purpose. Antihistamine.
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OTC - QUESTIONS SECTION.
Questions or comments. 1-800-923-5676Serious side effects associated with use of this product may be reported to this number.
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OTC - STOP USE SECTION.
Stop use and ask doctor if you experience any of following:eye painchanges in visionredness of the eyeitching worsens or lasts for more than 72 hours. eye pain. changes in vision. redness of the eye. itching worsens or lasts for more than 72 hours.
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OTC - WHEN USING SECTION.
When using this product. do not touch tip of container to any surface to avoid contaminationremove contact lenses before usewait at least 10 minutes before reinserting contact lenses after usereplace cap after each use. do not touch tip of container to any surface to avoid contamination. remove contact lenses before use. wait at least 10 minutes before reinserting contact lenses after use. replace cap after each use.
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.
Principal Display Panel Text for Container Label:Sunmark Logo(R) NDC 49348-107-17sterileeye itch reliefketotifen fumarateophthalmic solution 0.035%Antihistamine Eye Drops5 mL (0.17 FL OZ). Principal Display Panel Text for Container Label.
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WARNINGS SECTION.
Warnings. For external use only. Do not use. if solution changes color or becomes cloudyif you are sensitive to any ingredient in this productto treat contact lens related irritation. if solution changes color or becomes cloudy. if you are sensitive to any ingredient in this product. to treat contact lens related irritation. When using this product. do not touch tip of container to any surface to avoid contaminationremove contact lenses before usewait at least 10 minutes before reinserting contact lenses after usereplace cap after each use. do not touch tip of container to any surface to avoid contamination. remove contact lenses before use. wait at least 10 minutes before reinserting contact lenses after use. replace cap after each use. Stop use and ask doctor if you experience any of following:eye painchanges in visionredness of the eyeitching worsens or lasts for more than 72 hours. eye pain. changes in vision. redness of the eye. itching worsens or lasts for more than 72 hours. Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away. (1-800-222-1222).
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