Sinutab Sinus & Allergy (Acetaminophen Pseudoephedrine HCl Chlorpheniramine Maleate)
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ContraindicationsSensitivity to any of the components. Patients receiving MAO inhibitors.
Safety Information / WarningMassive acetaminophen overdose can be toxic and potentially fatal. In adults, hepatotoxicity from acetaminophen is unlikely to occur with overdoses of less than 10g ingested at one time and fatalities are unlikely to occur with overdoses of less than 15g ingested at one time.
PrecautionsRecommended dose should not be exceeded without consulting a physician.
Pregnancy: Safety in pregnancy not yet established.
Use with caution in elderly, pregnant or nursing patients, patients with hyperthyroidism, hypertension, glaucoma, asthma, chronic lung disease, prostatic hypertrophy, diabetes mellitus, cardiovascular diseases, chronic alcoholism, serious kidney or liver disease, in patients taking a drug for depression including MAO inhibitors.
Sinutab with Codeine: Codeine may be habit forming.
Occupational Hazards: Patients should be cautioned not to operate vehicles or hazardous machinery until their response to the drug has been determined.
Since the depressant effects of antihistamines are additive to those of other drugs affecting the CNS, patients should be cautioned against drinking alcoholic beverages or taking hypnotics, sedatives, psychotherapeutic agents or other drugs with CNS depressant effects during antihistaminic therapy.
Side Effects / Adverse EffectsAcetaminophen may occasionally cause gastric upset. The incidence and severity of this adverse effect is less than that after ASA administration.
Pseudoephedrine may cause mild stimulation, particularly in patients sensitive to sympathomimetic drugs. Drowsiness, confusion and gastrointestinal upset may occur with antihistamines. Excitement may occur in children. Nausea, diarrhea, mild stimulation, and abdominal pain from sympathomimetic agents may occur.
OverdoseSymptoms of massive overdosage include gastric irritation, nausea and vomiting, chills, hyperthermia, tinnitus, hypotension, circulatory collapse, cyanosis, methemoglobinemia, jaundice, coma, disorientation, hallucinations, hyperreflexia, tremors, convulsions, respiratory failure and renal damage.
Treatment: Evacuate the stomach by emesis or gastric lavage and administer activated charcoal.
Recommended DosageSinutab Sinus & Allergy: Regular Strength: Adults: 2caplets every 4to 6hours, not to exceed 4doses/day (maximum 8caplets/day). Children 6to 12years: 1caplet every 4to 6hours, not to exceed 4doses/day.
Extra Strength: Adults: 1to 2caplets every 4to 6hours, not to exceed 4doses/day (maximum 8caplets/day).
Supplied / PackagingSinutab Sinus & Allergy: Regular Strength: Each yellow caplet imprinted “Sinutab” on both sides contains: acetaminophen 325mg, pseudoephedrine HCl 30mg and chlorpheniramine maleate 2mg. Nonmedicinal ingredients: celluloses, D&C Yellow No.10, FD&C Yellow No.6, polyethylene glycol, polysorbate, starch, titanium dioxide, wax and zinc stearate. Energy: 0.76kJ (0.18kcal). Boxes of 12, 24 and 36 in blister packages.
Extra Strength: Each yellow caplet imprinted “Sinutab” on both sides contains: acetaminophen 500mg, pseudoephedrine HCl 30mg and chlorpheniramine maleate 2mg. Nonmedicinal ingredients: celluloses, D&C Yellow No.10, FD&C Yellow No.6, polyethylene glycol, polysorbate, starch, titanium dioxide, wax and zinc stearate. Energy: 0.76kJ (0.18kcal). Boxes of 24 in blister packages.