Label: ANTI-DIARRHEAL- loperamide hcl tablet
- NDC Code(s): 68016-301-06, 68016-301-18, 68016-301-24
- Packager: Chain Drug Consortium
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated December 20, 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?
Principal Display Panel
*COMPARE TO THE ACTIVE INGREDIENT IN IMODIUM® A-D
Loperamide HCl Tablets, 2 mg
Controls the symptoms
TAMPER EVIDENT: DO NOT USE IF PACKAGE
IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS
ANY SIGNS OF TAMPERING
*This product is not manufactured or distributed by Johnson &
Johnson Corporation, owner of the registered trademark Imodium® A-D.
Pharmacy Value Alliance, LLC
407 East Lancaster Avenue, Wayne, PA 19087
If for any reason you are not satisfied with
this product, please return it to the store
where purchased for a full refund.
Premier Value 44-375
INGREDIENTS AND APPEARANCE
loperamide hcl tablet
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68016-301 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:68016-301-06 1 in 1 CARTON 12/06/2019 1 6 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:68016-301-18 3 in 1 CARTON 12/06/2019 2 6 in 1 BLISTER PACK; Type 0: Not a Combination Product 3 NDC:68016-301-24 4 in 1 CARTON 12/06/2019 3 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 12/06/2019 Labeler - Chain Drug Consortium (101668460) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 manufacture(68016-301) , pack(68016-301) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 117025878 manufacture(68016-301)