Label: LOPERAMIDE HYDROCHLORIDE tablet, film coated
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Contains inactivated NDC Code(s)
NDC Code(s): 76413-314-12 - Packager: Central Texas Community Health Centers
- This is a repackaged label.
- Source NDC Code(s): 49348-529
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated April 19, 2016
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each caplet)
- Purpose
- Use
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Warnings
Allergy alert: Do not use if you have ever had a rash or other allergic reaction to loperamide HCl
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 on chart. 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; 1/2 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; 1/2 caplet after each subsequent loose stool; but no more than 2 caplets in 24 hours children under 6 years (up to 47 lbs) ask a doctor - Other information
- Inactive ingredients
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PRINCIPAL DISPLAY PANEL - 2 MG Tablet Blister Pack Carton Label
CommUnityCare Federally Qualified Health Centers
LOPERAMIDE
2MG Tablet
#12Date:
Name:
Dr.TAKE AS DIRECTED.
123456
1/1/01
LOPERAMIDE 2MG Tablet #12 NDC 76413-314-12
Batch: 123456
Lot: 123456
Exp: 1/1/01
SUNMARKFederal law prohibits the transfer of this drug to any other person than the patient for whom prescribed.
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INGREDIENTS AND APPEARANCE
LOPERAMIDE HYDROCHLORIDE
loperamide hydrochloride tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76413-314(NDC:49348-529) 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 ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) CARNAUBA WAX (UNII: R12CBM0EIZ) HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) Product Characteristics Color GREEN Score 2 pieces Shape CAPSULE Size 10mm Flavor Imprint Code L2 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76413-314-12 2 in 1 CARTON 06/27/2003 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 ANDA075232 06/27/2003 Labeler - Central Texas Community Health Centers (079674019) Establishment Name Address ID/FEI Business Operations Central Texas Community Health Centers 079674019 REPACK(76413-314) , RELABEL(76413-314)