DOSAGE & ADMINISTRATION SECTION.
Directions. Do not exceed recommended dosage.use only the enclosed dropper.do not use enclosed dropper for any other drug products.AGEDOSEAdutls Children 12 years of age or older:2 mL (2.5 mg) every to hours, not to exceed mL (10 mg) in 24 hours or as directed by doctor.Children to under12 years of age:1 mL (1.25 mg) every to hours, not to exceed mL (5 mg) in 24 hours or as directed by doctor.Children under years of age: Consult docotor.. use only the enclosed dropper.. do not use enclosed dropper for any other drug products.
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INACTIVE INGREDIENT SECTION.
Inactive ingredients. bubble gum flavor, citric acid, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose.
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INDICATIONS & USAGE SECTION.
Uses. temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies:runny nosesneezingitching of the nose or throatitchy, watery eyes. runny nose. sneezing. itching of the nose or throat. itchy, watery eyes.
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OTC - ACTIVE INGREDIENT SECTION.
Active ingredient (in each mL dropperful). Triprolidine HCl 1.25 mg.
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OTC - ASK DOCTOR SECTION.
Ask doctor before use if the child hasa breathing problem such as emphysema or chronic bronchitisglaucoma. breathing problem such as emphysema or chronic bronchitis. glaucoma.
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OTC - ASK DOCTOR/PHARMACIST SECTION.
Ask doctor before use if the child is taking sedatives or tranquilizers.
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OTC - DO NOT USE SECTION.
Do not exceed recommended dosage.
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OTC - KEEP OUT OF REACH OF CHILDREN SECTION.
Keep out of the reach of children.In case of overdose, get medical help or contact Poison Control Center right away.
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OTC - PURPOSE SECTION.
Purpose. Antihistamine.
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OTC - QUESTIONS SECTION.
Questions Comments. Call 1-866-633-9033.
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OTC - STOP USE SECTION.
Stop use and ask doctor ifnew symptoms occur. new symptoms occur.
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OTC - WHEN USING SECTION.
When using this productexcitability may occur, especially in childrenmay cause drowsinesssedatives and tranquilizers may increase the drowsiness effect. excitability may occur, especially in children. may cause drowsiness. sedatives and tranquilizers may increase the drowsiness effect.
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.
PRINCIPAL DISPLAY PANEL 30 mL Bottle Carton. NDC 28595-808-30HISTEX(TM) PDX Drops AntihistamineEach dropperful (1 mL) contains: Triprolidine HCl 1.25 mg Sugar-Free Dye Free Alcohol Free Bubble Gum Flavor1 fl oz (30 mL) Bottle. Carton.
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RECENT MAJOR CHANGES SECTION.
Recent Major Changes. The Direction section has been updated with new dosage information. Inactive ingredients section has been updated to reflect the change in two ainactive ingredients.
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SPL UNCLASSIFIED SECTION.
Drug Facts.
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STORAGE AND HANDLING SECTION.
Other Information. Store at 15-30 (59-86 F).Tamper evident by foil seal under cap. Do not use if foil seal is missing or broken.
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WARNINGS SECTION.
Warnings. Do not exceed recommended dosage.. Ask doctor before use if the child hasa breathing problem such as emphysema or chronic bronchitisglaucoma. breathing problem such as emphysema or chronic bronchitis. glaucoma. Ask doctor before use if the child is taking sedatives or tranquilizers. When using this productexcitability may occur, especially in childrenmay cause drowsinesssedatives and tranquilizers may increase the drowsiness effect. excitability may occur, especially in children. may cause drowsiness. sedatives and tranquilizers may increase the drowsiness effect. Stop use and ask doctor ifnew symptoms occur. new symptoms occur. Keep out of the reach of children.In case of overdose, get medical help or contact Poison Control Center right away.
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