DOSAGE & ADMINISTRATION SECTION.
Directions. Adults (12 and older): One tablet every to hours. Not to exceed doses in 24 hours. Children under 12 years of age: Consult physician. Adults (12 and older): One tablet every to hours. Not to exceed doses in 24 hours. Children under 12 years of age: Consult physician. Other information. store at 20-25C (68-77F).
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INACTIVE INGREDIENT SECTION.
Inactive ingredient. colloidal silicon dioxide, crospovidone polyplasdone, D&C Red 30, D&C Yellow 10, FD&C Blue 1, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone.
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INDICATIONS & USAGE SECTION.
Uses. For the temporary relief ofrunny nosesneezingitching of the nose or throatitchy, watery eyes due to hay fever or other upper respiratory allergiesnasal congestionTemporarily helpsclear nasal passagesshrink swollen membranes. runny nose. sneezing. itching of the nose or throat. itchy, watery eyes due to hay fever or other upper respiratory allergies. nasal congestion. clear nasal passages. shrink swollen membranes.
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OTC - ACTIVE INGREDIENT SECTION.
Active Ingredients (per tablet). Dexchlorpheniramine Maleate mgPseudoephedrine Hydrochloride 60 mg.
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OTC - ASK DOCTOR SECTION.
Ask doctor before use if you have. glaucomaheart diseasehigh blood pressurethyroid diseasediabetesdifficulty in urination due to enlargement of the prostate glandor if you are taking sedatives or tranquilizers. glaucoma. heart disease. high blood pressure. thyroid disease. diabetes. difficulty in urination due to enlargement of the prostate gland. or if you are taking sedatives or tranquilizers.
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OTC - DO NOT USE SECTION.
Do not use. If you have breathing problem such as emphysema or chronic bronchitisIf you are now taking prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinsons disease), or for weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask doctor or pharmacist before taking this product. If you have breathing problem such as emphysema or chronic bronchitis. If you are now taking prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinsons disease), or for weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask doctor or pharmacist before taking this product.
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OTC - KEEP OUT OF REACH OF CHILDREN SECTION.
Keep out of the reach of children. In case of accidental overdose, seek professional help or contact Poison Control Center immediately.
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OTC - PREGNANCY OR BREAST FEEDING SECTION.
If pregnant or breast feeding. Ask health professional before use.
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OTC - PURPOSE SECTION.
Purpose. Dexchlorpheniramine Maleate AntihistaminePseudoephedrine Hydrochloride Nasal Decongestant.
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OTC - QUESTIONS SECTION.
Questions or Comments. Serious side effects may be reported to this number, call (817) 595-5820. (8 am to 5).
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OTC - STOP USE SECTION.
Stop use and ask doctor. If nervousness, dizziness, or sleeplessness occur.If symptoms do not improve within days or are accompanied by fever.. If nervousness, dizziness, or sleeplessness occur.. If symptoms do not improve within days or are accompanied by fever.
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OTC - WHEN USING SECTION.
When using this product. Avoid alcoholic beveragesUse caution when driving motor vehicle or operating machinery.. Avoid alcoholic beverages. Use caution when driving motor vehicle or operating machinery.
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL. Figure 1: 90 ct product label figure-01.
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SPL UNCLASSIFIED SECTION.
Drug Facts.
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WARNINGS SECTION.
Warnings. Do not exceed recommended dosageMay cause excitability especially in children May cause drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect.. Do not exceed recommended dosage. May cause excitability especially in children. May cause drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect.
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