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Singlet Caplets (Glaxosmithkline)

  • Indications and Usage
  • Dosage and Administration
  • Warnings
  • Drug Interactions
  • Description

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  • Indications:    For temporary relief of nasal congestion and sinus and headache pain associated with sinusitis or due to a cold, hay fever or other upper respiratory allergies. Also temporarily relieves nasal congestion, sinus headache, runny nose, sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever or other upper respiratory allergies. Also temporarily relieves fever due to the common cold.

    Directions:    Adults (12 years and older): 1 caplet every 4 to 6 hours, not to exceed 4 caplets in any 24-hour period, or as directed by a doctor. Children under 12 years of age: Consult a doctor.

    Warnings:    Do not exceed recommended dosage. If nervousness, dizziness, or sleeplessness occur, discontinue use and consult a doctor. Do not take this product for more than 10 days. If symptoms do not improve or are accompanied by fever that lasts for more than 3 days, or if new symptoms occur, consult a doctor. Do not take this product, unless directed by a doctor, if you have a breathing problem such as emphysema or chronic bronchitis, or if you have heart disease, high blood pressure, thyroid disease, diabetes, glaucoma or difficulty in urination due to enlargement of the prostate gland. May cause excitability especially in children. May cause drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect. Avoid alcoholic beverages while taking this product. Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor. Use caution when driving a motor vehicle or operating machinery. KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately. As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product.

    Alcohol Warning:   If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain reliever/fever reducers. Acetaminophen may cause liver damage.

    Drug Interaction Precaution:    Do not use this product if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you are uncertain whether your prescription drug contains an MAOI, consult a health professional before taking this product.

    Active Ingredients:    Each caplet contains: Pseudoephedrine Hydrochloride 60 mg, Chlorpheniramine Maleate 4 mg, Acetaminophen 650 mg.

    Inactive Ingredients:    D&C Red 27, D&C Yellow 10, FD&C Blue 1, Hydroxypropyl Cellulose, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Pregelatinized Corn Starch, Sodium Starch Glycolate, Sucrose and Titanium Dioxide.

    Store at room temperature (59°-86°F). Avoid excessive heat and humidity.

    Comments or Questions? Call toll-free 1-800-245-1040 weekdays

    Distributed by: Glaxosmithkline Consumer Healthcare, L.P.

    Moon Township, PA 15108. Made in U.S.A.

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    This page was last modified 30-JUN-07
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