Label: ANTI-DIARRHEAL- loperamide hcl tablet
- NDC Code(s): 21130-375-08
- Packager: Better Living Brands, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated May 2, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each caplet)
- Purpose
- Use
-
Warnings
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.
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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 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
Signature™
careQuality
GuaranteedCOMPARE TO
Imodium® A-D
active ingredient*NDC 21130-375-08
Anti-Diarrheal
LOPERAMIDE HCl 2 mg
Anti-DiarrhealControls the symptoms
of diarrheaActual Size
24 CAPLETS
*This product is not manufactured or distributed by Johnson & Johnson
corporation, distributors of Imodium® A-D.
50844 REV0619N37508TAMPER EVIDENT: DO NOT USE IF
PACKAGE IS OPENED OR IF BLISTER
UNIT IS TORN, BROKEN OR SHOWS
ANY SIGNS OF TAMPERING
DISTRIBUTED BY
BETTER LIVING BRANDS LLC
P.O. BOX 99, PLEASANTON, CA 94566-0009
1-888-723-3929
www.betterlivingbrandsLLC.com1. To open, tear
at perforations and
remove a section.2. Use ✄ to cut
through plastic
for caplet.OUR PROMISE
QUALITY & SATISFACTION
100% GUARANTEED
OR YOUR MONEY BACK.Signature Care 44-375
-
INGREDIENTS AND APPEARANCE
ANTI-DIARRHEAL
loperamide hcl tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:21130-375 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:21130-375-08 4 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 - Better Living Brands, LLC (009137209) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 manufacture(21130-375) , pack(21130-375) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 117025878 manufacture(21130-375)