NDC 0113-6004 Injoy Diarrhea Relief
Loperamide Hcl Tablet, Film Coated Oral
Product Information
What is NDC 0113-6004?
The NDC code 0113-6004 is assigned by the FDA to the product Injoy Diarrhea Relief which is a human over the counter drug product labeled by L. Perrigo Company. The generic name of Injoy Diarrhea Relief is loperamide hcl. The product's dosage form is tablet, film coated and is administered via oral form. The product is distributed in a single package with assigned NDC code 0113-6004-62 24 blister pack in 1 carton / 1 tablet, film coated in 1 blister pack. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.
What are the uses for Injoy Diarrhea Relief?
See also Warning section. This medication is used to treat sudden diarrhea (including traveler's diarrhea). It works by slowing down the movement of the gut. This decreases the number of bowel movements and makes the stool less watery. Loperamide is also used to reduce the amount of discharge in patients who have had an ileostomy. It is also used to treat ongoing diarrhea in people with inflammatory bowel disease. Loperamide treats only the symptoms, not the cause of the diarrhea (e.g., infection). Treatment of other symptoms and the cause of the diarrhea should be determined by your doctor.
Product Characteristics
Color(s) | GREEN (C48329) |
Shape | OVAL (C48345) |
Size(s) | 10 MM |
Imprint(s) | L2 |
Score | 2 |
Product Packages
NDC Code 0113-6004-62
Package Description: 24 BLISTER PACK in 1 CARTON / 1 TABLET, FILM COATED in 1 BLISTER PACK
Product Details
What are Injoy Diarrhea Relief Active Ingredients?
- LOPERAMIDE HYDROCHLORIDE 2 mg/1 - One of the long-acting synthetic ANTIDIARRHEALS; it is not significantly absorbed from the gut, and has no effect on the adrenergic system or central nervous system, but may antagonize histamine and interfere with acetylcholine release locally.
Injoy Diarrhea Relief Active Ingredients UNII Codes
- LOPERAMIDE HYDROCHLORIDE (UNII: 77TI35393C)
- LOPERAMIDE (UNII: 6X9OC3H4II) (Active Moiety)
NDC to RxNorm Crosswalk
- RxCUI: 978010 - loperamide HCl 2 MG Oral Tablet
- RxCUI: 978010 - loperamide hydrochloride 2 MG Oral Tablet
Injoy Diarrhea Relief Inactive Ingredients UNII Codes
- ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
- CARNAUBA WAX (UNII: R12CBM0EIZ)
- D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
- FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
- HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
- MAGNESIUM STEARATE (UNII: 70097M6I30)
- MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
- POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
Pharmacologic Class(es)
* Please review the disclaimer below.
Injoy Diarrhea Relief Product Label
FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
Product Label Table of Contents
- ACTIVE INGREDIENT (IN EACH CAPLET)
- PURPOSE
- USE
- WARNINGS
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
Active Ingredient (In Each Caplet)
Loperamide HCl 2 mg
Purpose
Anti-diarrheal
Use
controls symptoms of diarrhea, including Travelers’ Diarrhea
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
Do Not Use
if you have bloody or black stool
Ask A Doctor Before Use If You Have
• 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.
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children.
In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
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 to 47 lbs) | ask a doctor |
children under 2 years (up to 33 lbs) | do not use |
Other Information
• store at 20°-25°C (68°-77°F)• see end panel for lot number and expiration date
Inactive Ingredients
anhydrous lactose, carnauba wax, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch
Questions Or Comments?
1-800-864-9649
Principal Display Panel
SEE NEW WARNINGS
PERRIGO Selfcare™
injoy
Diarrhea Relief
Loperamide Hydrochloride Tablets, 2 mg
Anti-diarrheal
Controls the symptoms of diarrhea
24 CAPLETS*
*CAPSULE SHAPED TABLETS
ACTUAL SIZE
* Please review the disclaimer below.