Label: ANTI-DIARRHEAL- loperamide hcl tablet
- NDC Code(s): 57896-381-13, 57896-381-25
- Packager: Geri-Care Pharmaceutical Corp
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated October 19, 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
Heart alert: Taking more than directed can cause serious heart problems or death.
Do not use if you have bloody or black stool
Ask a doctor before use if you have
- a fever
- mucus present in your stool
- a history of liver disease
- a history of abnormal heart rhythm
Ask a doctor or pharmacist before use if 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.
Stop use and ask a doctor if
- diarrhea lasts for more than 2 days
- symptoms get worse
- you get abdominal swelling or bulging.
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 caused by diarrhea
- find right dose on chart. If possible, use weight to dose; otherwise, use age.
adults and children
12 years and over2 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; 1/2 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; 1/2 caplet after each subsequent
loose stool; but no more than 2 caplets in 24 hourschildren 2-5 years (34-47 lbs) ask a doctor children under 2 years (up to 33 lbs) do not use - 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: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 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) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP) 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:57896-381-25 4 in 1 CARTON 09/01/2020 1 6 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:57896-381-13 2 in 1 CARTON 03/01/2021 2 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 ANDA076497 01/01/2006 Labeler - Geri-Care Pharmaceutical Corp (611196254) Registrant - Geri-Care Pharmaceutical Corp (611196254)
