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
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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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 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076497 05/03/2005 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)