Label: ANTI-DIARRHEAL- marc glassman capsule
- NDC Code(s): 68998-248-92
- Packager: Marc Glassman, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated September 1, 2020
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- Official Label (Printer Friendly)
- Active ingredient(s)
- Purpose
- Use(s)
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Warnings
Allergy alert: Do not use if you have ever had a rash or other allergic reaction to Loperamide HCl.
Heart alert: Taking more than directed can cause serious heart problems or death.
Ask a doctor before use if
you have ■ fever ■ mucus in the stool ■ a history of liver disease ■ a history of abnormal heart rhythm
you are taking a prescription drug. Loperamide may interact with certain prescription drugs.
When using this product
tiredness, drowsiness or dizziness may occur. Be careful when driving or operating machinery.
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Directions
drink plenty of clear fluids to help prevent dehydration caused by diarrhea
■ find right dose below. If possible, use weight to dose; otherwise, use age.
■ adults and children 12 years and over: 2 caplets after the first loose stool; 1 caplet after each subsequent loose stool; but no more than 4 caplets in 24 hours
■ children 9-11 years (60-95 lbs): 1 caplet after the first loose stool; ½ caplet after each subsequent loose stool; but no more than 3 caplets in 24 hours
■ children 6-8 years (48-59 lbs): 1 caplet after the first loose stool; ½ caplet after each subsequent loose stool; but no more than 2 caplets in 24 hours
■ children 2-5 years (34 to 47 lbs): ask a doctor
■ children under 2 years (up to 33 lbs): do not use - Other information
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- Inactive ingredients
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INGREDIENTS AND APPEARANCE
ANTI-DIARRHEAL
marc glassman capsuleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68998-248 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LOPERAMIDE HYDROCHLORIDE (UNII: 77TI35393C) (LOPERAMIDE - UNII:6X9OC3H4II) LOPERAMIDE HYDROCHLORIDE 2 mg Inactive Ingredients Ingredient Name Strength STARCH, CORN (UNII: O8232NY3SJ) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Product Characteristics Color green Score 2 pieces Shape CAPSULE Size 10mm Flavor Imprint Code 44;375 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68998-248-92 24 in 1 CARTON; Type 0: Not a Combination Product 05/03/2005 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076497 05/03/2005 Labeler - Marc Glassman, Inc. (094487477)
