Label: ANTI DIARRHEAL- loperamide hcl capsule
- NDC Code(s): 67091-405-12
- Packager: WinCo Foods
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated January 6, 2022
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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 reactions to loperamide HCl.
Heart alert: Taking more than directed can cause serious heart problems or death.
Ask a doctor before use if
- fever
- mucus in the stool
- a history of liver disease
- a history of abnormal heart rhythm
Ask a doctor or pharmacist before use if
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
- Inactive ingredients
- Questions
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INGREDIENTS AND APPEARANCE
ANTI DIARRHEAL
loperamide hcl capsuleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67091-405 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) D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6) DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP) MAGNESIUM STEARATE (UNII: 70097M6I30) FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) 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:67091-405-12 12 in 1 BLISTER PACK; Type 0: Not a Combination Product 03/01/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076497 03/01/2022 Labeler - WinCo Foods (056098817)
