Label: ANTI-DIARRHEAL LOPERAMIDE HCL, 2 MG CAPLETS- loperamide hcl tablet
- NDC Code(s): 66424-735-02, 66424-735-96
- Packager: SDA Laboratories, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated April 29, 2021
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- Drug Facts
- Active ingredient (in each caplet)
Allergy alert: Do not use if you have ever had a rash or other allergic reaction to loperamide HCl.
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 • fever • mucus in the stool • a history of liver disease
Ask a doctor or pharmacist before use if you are taking antibiotics
When using this product tiredness, drowsiness, or dizziness may occur. Be careful when driving or operating machinery.
Stop use and ask a doctor if • symptoms get worse • diarrhea lasts more than 2 days • 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.
- drink plenty of clear liquids to help prevent dehydration caused by diarrhea
- find the right dose on the 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
SPL UNCLASSIFIED SECTION
Compare to the active ingredient in Imodium® A-D†
ORIGINAL PRESCRIPTION STRENGTH
CONTROLS SYMPTOMS OF DIARRHEA
DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED
†This product is not manufactured or distributed by the owner of the registered trademark of Imodium® A-D.
SDA Laboratories, Inc.
Greenwich, CT 06830
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
ANTI-DIARRHEAL LOPERAMIDE HCL, 2 MG CAPLETS
loperamide hcl tablet
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66424-735 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) DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Product Characteristics Color green Score 2 pieces Shape OVAL Size 10mm Flavor Imprint Code 44;375 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66424-735-02 200 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/01/2018 2 NDC:66424-735-96 96 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/28/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076497 09/01/2018 Labeler - SDA Laboratories, Inc. (948067889)