FDA Label for Loperamide Hydrochloride
View Indications, Usage & Precautions
- 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?
- PRINCIPAL DISPLAY PANEL
Loperamide Hydrochloride Product Label
The following document was submitted to the FDA by the labeler of this product Valu Merchandisers Company. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient (In Each Caplet)
Loperamide HCI USP, 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 HCI
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
Ask A Doctor Or Pharmacist Before Use If You Are
Taking antibiotics
When Using This Product
- tiredness, drowsiness or dizziness may occur. Be careful when driving or operating machinery.
Stop Use And Ask A Doctor If
- diarrhea lasts for more than 2 days
- symptoms get worse
- 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.
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 hourschildren 9-11 years
(60-95 lbs)1 caplet after the first loose stool;
½ caplet after each subsequent loose stool; but no more than 3 caplets in 24 hourschildren 6-8 years
(48-59 lbs)1 caplet after the first loose stool;
½ caplet after each subsequent loose stool; but no more than 2 caplets in 24 hourschildren under 6 years
(up to 47 lbs)ask a doctor
Other Information
- store between 20° – 25° C (68° – 77° F)
- see side panel for lot number and expiration date
- TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE.
Inactive Ingredients
Anhydrous lactose, croscarmellose sodium, crospovidone, D&C yellow no.10, FD&C blue no.1, hydrogenated vegetable oil, magnesium stearate, powdered cellulose, pregelatinized starch
Questions?
Call 1800-406-7984
Principal Display Panel
COMPARE TO ACTIVE INGREDIENT IN IMODIUM®A-D**
Best Choice®Brand
ANTI-DIARRHEAL
Loperamide Hydrochloride Tablets USP, 2 mg
Controls the Symptoms of Diarrhea
Easy to Swallow
24 CAPLETS*
*Each Capsule-shaped Tablet Contains Loperamide HCl USP, 2 mg
DISTRIBUTED BY: VALU MERCHANDISERS, CO.
5070467/R1208
* Please review the disclaimer below.