Label: ANTI DIARRHEAL- loperamide hydrochloride capsule
- NDC Code(s): 76000-375-22
- Packager: Bedrock Brands, LLC
- 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 1-855-GODIGEL (1-855-463-4435)Close
- Principal Display Panel
LOPERAMIDE HCl 2 mg
CONTROLS THE SYMPTOMS
bloating & pressure
Distributed by: di•gel Health Products, LLC.
323 W. Camden Street, Baltimore, MD 21201
1-855-GODIGEL • www.godigel.com
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
- INGREDIENTS AND APPEARANCE
loperamide hcl capsule
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76000-375 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) 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:76000-375-22 1 in 1 CARTON 1 48 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076497 05/03/2005 Labeler - Bedrock Brands, LLC (829056162) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 MANUFACTURE(76000-375) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 PACK(76000-375)