IMPORTANT SAFETY INFORMATION

INDICATION
SUTAB^® (sodium sulfate, magnesium sulfate, potassium chloride) tablets for oral use is an osmotic laxative indicated for cleansing of the colon in preparation for colonoscopy in adults.

DOSAGE AND ADMINISTRATION
A low residue breakfast may be consumed. After breakfast, only clear liquids may be consumed until after the colonoscopy. Administration of two doses of SUTAB (24 tablets) are required for a complete preparation for colonoscopy. Twelve (12) tablets are equivalent to one dose. Water must be consumed with each dose of SUTAB and additional water must be consumed after each dose. Complete all SUTAB tablets and required water at least 2 hours before colonoscopy

CONTRAINDICATIONS
Use is contraindicated in the following conditions: gastrointestinal obstruction or ileus, bowel perforation, toxic colitis or toxic megacolon, gastric retention.

WARNINGS AND PRECAUTIONS
Risk of fluid and electrolyte abnormalities: Encourage adequate hydration, assess concurrent medications and consider laboratory assessments prior to and after each use. Cardiac arrhythmias: Consider pre-dose and post-colonoscopy ECGs in patients at increased risk. Seizures: Use caution in patients with a history of seizures and patients at increased risk of seizures, including medications that lower the seizure threshold. Patients with renal impairment or taking concomitant medications that affect renal function: Use caution, ensure adequate hydration and consider laboratory testing. Suspected GI obstruction or perforation: Rule out the diagnosis before administration.

ADVERSE REACTIONS
Most common gastrointestinal adverse reactions are nausea, abdominal distension, vomiting, and upper abdominal pain.

DRUG INTERACTIONS
Drugs that increase risk of fluid and electrolyte imbalance.

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SUPREP^® Bowel Prep Kit (sodium sulfate, potassium sulfate and magnesium sulfate) Oral Solution is an osmotic laxative indicated for cleansing of the colon as a preparation for colonoscopy in adults. Most common adverse reactions (>2%) are overall discomfort, abdominal distention, abdominal pain, nausea, vomiting and headache. Use is contraindicated in the following conditions: gastrointestinal (GI) obstruction, bowel perforation, toxic colitis and toxic megacolon, gastric retention, ileus, known allergies to components of the kit. Use caution when prescribing for patients with a history of seizures, arrhythmias, impaired gag reflex, regurgitation or aspiration, severe active ulcerative colitis, impaired renal function or patients taking medications that may affect renal function or electrolytes. Use can cause temporary elevations in uric acid. Uric acid fluctuations in patients with gout may precipitate an acute flare. Administration of osmotic laxative products may produce mucosal aphthous ulcerations, and there have been reports of more serious cases of ischemic colitis requiring hospitalization. Patients with impaired water handling who experience severe vomiting should be closely monitored including measurement of electrolytes. Advise all patients to hydrate adequately before, during, and after use. Each bottle must be diluted with water to a final volume of 16 ounces and ingestion of additional water as recommended is important to patient tolerance.

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IMPORTANT SAFETY INFORMATION

Topical corticosteroids are indicated for the relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation. Use may produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression. May cause local adverse reactions including burning, itching, irritation, and dryness.

Pregnancy: Teratogenic Effects: Pregnancy Category C

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Important Safety Information

INDICATIONS AND USAGE
Motofen^® (difenoxin and atropine sulfate tablets) is indicated as adjunctive therapy in the management of acute nonspecific diarrhea and acute exacerbations of chronic functional diarrhea.

CONTRAINDICATIONS
Motofen^® is contraindicated in patients with diarrhea associated with organisms that penetrate the intestinal mucosa (toxigenic E. coli, Salmonella species, Shigella) and pseudomembranous colitis associated with broad spectrum antibiotics.

Motofen^® is also contraindicated in children under 2 years of age, in patients with known hypersensitivity to difenoxin, atropine, or any of the inactive ingredients, and in patients who are jaundiced.

WARNINGS
Motofen^® is not an innocuous drug and dosage recommendations should be strictly adhered to. Accidental overdose may result in severe respiratory depression and coma, possibly leading to permanent brain damage or death.

The use of Motofen^® does not preclude the administration of appropriate fluid and electrolyte therapy. Dehydration, particularly in children, may further influence the variability of response to Motofen^® and may predispose to delayed difenoxin intoxication. Drug-induced inhibition of peristalsis may result in fluid retention in the colon, and this may further aggravate dehydration and electrolyte imbalance.

Use with caution in patients with ulcerative colitis or liver or kidney disease.

Motofen^® may produce drowsiness or dizziness. Use caution when engaging in activities requiring mental alertness, such as driving or operating dangerous machinery.

Keep out of reach of children.

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INDICATIONS AND USAGE: NAFTIN (Naftifine HCl) GEL 2% is an allylamine antifungal indicated for the treatment of interdigital tinea pedis caused by the organisms Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum in patients 12 years of age and older.

IMPORTANT SAFETY INFORMATION

ADVERSE REACTIONS: In clinical trials with NAFTIN GEL 2%, the most common adverse reactions (2%) were application site reactions.

WARNINGS AND PRECAUTIONS: If redness or irritation develops with the use of NAFTIN GEL 2%, treatment should be discontinued.

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IMPORTANT SAFETY INFORMATION Pramosone^® Lotion 2.5% (Hydrocortisone Acetate 2.5% and Pramoxine HCl 1%) is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation. Use may produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression. May cause local adverse reactions including burning, itching, irritation and dryness.

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