Label: ANTI-DIARRHEAL- loperamide hcl tablet
- NDC Code(s): 64092-105-12
- Packager: GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated September 21, 2022
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- Official Label (Printer Friendly)
- 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.
Ask a doctor before use if you have
- a fever
- 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 (34-47 lbs) ask a doctor children under 2 years (up to 33 lbs) do not use
- Other information
- Inactive ingredients
- Questions or comments?
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active ingredient in
Loperamide HCl Tablets, 2 mg
Controls the Symptoms of Diarrhea
*This product is not manufactured or distributed by
Johnson & Johnson Corporation, owner of the registered
trademark Imodium® A-D. 50844 REV0619M37502
1. To open, tear at perforations and remove a section.
2. Use scissors to cut through plastic for caplet.
If you are not completely satisfied with this
product, regardless of reason, return your unused
portion to Great Lakes Wholesale for a full refund
Distributed By: Great Lakes Wholesale & Marketing L.L.C.
3729 Patterson Ave. S.E., Grand Rapids, MI 49512
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS
OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR
SHOWS ANY SIGNS OF TAMPERING
INGREDIENTS AND APPEARANCE
loperamide hcl tablet
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:64092-105 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) FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM) 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:64092-105-12 2 in 1 CARTON 05/03/2005 1 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 05/03/2005 Labeler - GREAT LAKES WHOLESALE, MARKETING, & SALES, INC. (361925498) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 manufacture(64092-105) , pack(64092-105) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 117025878 manufacture(64092-105)