Label: IMODIUM A-D- loperamide hydrochloride tablet, film coated
50580-317-05, view more50580-317-06
- Packager: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated May 13, 2021
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- SPL UNCLASSIFIED SECTION
- Active ingredient (in each caplet)
Ask a doctor before use if you have
- mucus in the 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
- symptoms get worse
- diarrhea lasts for more than 2 days
- you get abdominal swelling or bulging. These may be signs of a serious condition.
- 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 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 or comments?
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
loperamide hydrochloride tablet, film coated
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50580-317 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) hypromellose, unspecified (UNII: 3NXW29V3WO) magnesium stearate (UNII: 70097M6I30) microcrystalline cellulose (UNII: OP1R32D61U) polyethylene glycol, unspecified (UNII: 3WJQ0SDW1A) Product Characteristics Color WHITE Score 2 pieces Shape OVAL Size 11mm Flavor Imprint Code IMO;2;MG Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50580-317-01 1 in 1 CARTON 07/13/2015 1 6 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:50580-317-03 4 in 1 CARTON 07/13/2015 2 6 in 1 BLISTER PACK; Type 0: Not a Combination Product 3 NDC:50580-317-04 6 in 1 CARTON 07/13/2015 12/31/2018 3 6 in 1 BLISTER PACK; Type 0: Not a Combination Product 4 NDC:50580-317-05 8 in 1 CARTON 07/13/2015 4 6 in 1 BLISTER PACK; Type 0: Not a Combination Product 5 NDC:50580-317-06 2 in 1 CARTON 02/10/2020 5 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 07/13/2015 Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)