Label: ANTI-DIARRHEAL- loperamide hcl tablet
- NDC Code(s): 68788-7369-1, 68788-7369-2
- Packager: Preferred Pharmaceuticals Inc.
- This is a repackaged label.
- Source NDC Code(s): 57896-381
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated July 25, 2023
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- Official Label (Printer Friendly)
- Active ingredient(in each caplet)
- Purpose
- Uses
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Warnings
Allergy alert: Do not use if you have ever had a rash or other allergic reaction to loperamide HCI
Do not use
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- if you have bloody or black stool
Ask a doctor before use if you have
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- fever
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- mucus present in your stool
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- a history of liver disease
Ask a doctor or pharmacist before use if you are
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- taking antibiotics
When using this product
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- tiredness, drowsiness or dizziness may occur. Be careful when driving or operating machinery.
Stop use and ask a doctor if
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- diarrhea lasts for more than 2 days
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- symptoms get worse
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- you get abdominal swelling
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- these may be signs of a serious condition
If pregnant or breast-feeding, ask a health professional before use.
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Directions
drink plenty of clear fluids to help prevent dehydration,which may accompany diarrhea
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- do not exceed recommended dose
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- Adults and children 12 years and over: 2 caplets after the first loose bowel movement; 1 caplet after each subsequent loose bowel movement; do not exceed 4 caplets in 24 hours
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- Children under 12 years: Ask a doctor
- Other Information
- Inactive Ingredients
- package Label
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INGREDIENTS AND APPEARANCE
ANTI-DIARRHEAL
loperamide hcl tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68788-7369(NDC:57896-381) 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 DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) STARCH, CORN (UNII: O8232NY3SJ) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) MAGNESIUM STEARATE (UNII: 70097M6I30) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Product Characteristics Color green (light green) Score 2 pieces Shape CAPSULE Size 7mm Flavor Imprint Code 44375 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68788-7369-2 24 in 1 BOTTLE; Type 0: Not a Combination Product 08/25/2016 2 NDC:68788-7369-1 12 in 1 BOTTLE; Type 0: Not a Combination Product 06/21/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076497 08/25/2016 Labeler - Preferred Pharmaceuticals Inc. (791119022) Registrant - Preferred Pharmaceuticals Inc. (791119022) Establishment Name Address ID/FEI Business Operations Preferred Pharmaceuticals Inc. 791119022 RELABEL(68788-7369)
