Label: LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE tablet
- NDC Code(s): 62207-739-69
- Packager: Granules India Ltd
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated January 27, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredients (in each caplet)
- Purposes
- Uses
- Warnings
- Do not use
- Ask a doctor before use if you have
- Ask a doctor or pharmacist before use if you are
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children.
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Directions
- drink plenty of clear fluids to help prevent dehydration caused by diarrhea
- take only on an empty stomach (1 hour before or 2 hours after a meal)
- take with a full (8 oz.) glass of water
- find right dose on chart below. If possible, use weight to dose; otherwise, use ag
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 hourschildren 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 hourschildren 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 hourschildren 2-5 years (34 to 47 lbs) ask a doctor children under 2 years (up to 33 lbs) do not use Other information
- each caplet contains: calcium 148.40 mg, sodium 1.40 mg
- store between 20-25°C (68-77°F). Protect from light.
- for blister: do not use if blister unit is torn or broken
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Inactive Ingredients
acesulfame potassium, anhydrous dibasic calcium phosphate, colloidal silicon dioxide, croscarmellose sodium, flavor, microcrystalline cellulose, stearic acid.
Questions or comments?Contact 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST
Manufactured by:
Granules India Limited
Hyderabad-500 081, INDIA
MADE IN INDIA - PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE
loperamide hydrochloride and simethicone tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62207-739 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 DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 125 mg Inactive Ingredients Ingredient Name Strength MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) ACESULFAME POTASSIUM (UNII: 23OV73Q5G9) STEARIC ACID (UNII: 4ELV7Z65AP) ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Product Characteristics Color white (off white) Score 2 pieces Shape CAPSULE (Capsule shaped tablet) Size 17mm Flavor VANILLA Imprint Code I;9 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62207-739-69 2 in 1 CARTON 03/01/2023 1 6 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA215981 03/01/2023 Labeler - Granules India Ltd (915000087)