Label: ANTI DIARRHEAL- loperamide hydrochloride tablet
- NDC Code(s): 68196-375-04
- Packager: Sam's West Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
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- Active ingredient (in each caplet)
Loperamide HCl 2 mgClose
controls symptoms of diarrhea, including Travelers' DiarrheaClose
Allergy alert: Do not use if you have ever had a rash or other allergic reactions to loperamide HCl.
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 buldging. These may be signs of a serious condition.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
- drink plenty of clear fluids to help prevent dehydration caused by diarrhea
- find right dose on chat. If possible, use weight to dose; otherwise, use age.
adults and children 12 years and older 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 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
- do not use if carton or safety seal is broken or missing
- store between 20º-25ºC (68º-77ºF)
- see end flap for expiration date and lot number
- Inactive ingredients
corn starch, D&C yellow # 10 aluminum lake, dicalcium phosphate dihydrate, FD&C blue #1 brilliant blue lake, magnesium stearate, microcrystalline cellulose, silica gelClose
- Questions or comments?
Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-FridayClose
- Principal Display Panel
Loperamide Hydrochloride caplets, 2 mg
Compare to Imodium A-D® active ingredient*
controls the symptoms of diarrhea
easy to swallow, small caplets
Each caplet (capsule-shaped tablets) contains2 mg Loperamide Hydrochloride
*This product is not manufactured or distributed by McNeil consumer Healthcare, owner of the registered trademark Imdium A-D®.
SAM'S West, Inc.
Bentonville, AR 72716
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Simply Right 44-375
- INGREDIENTS AND APPEARANCE
loperamide hcl tablet
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68196-375 Route of Administration ORAL DEA Schedule 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 MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Product Characteristics Color BLUE Score no score Shape CAPSULE Size 10mm Flavor Imprint Code 44;375 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68196-375-04 1 in 1 CARTON 1 350 in 1 BOTTLE; 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 07/02/2018 Labeler - Sam's West Inc (051957769) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 PACK(68196-375) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 MANUFACTURE(68196-375)