FDA Label for Loperamide Hydrochloride
View Indications, Usage & Precautions
- OTHER
- ACTIVE INGREDIENT (IN EACH CAPLET)
- PURPOSE
- USE
- ALLERGY ALERT
- HEART ALERT
- OTC - DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- OTC - ASK DOCTOR/PHARMACIST
- OTC - WHEN USING
- STOP USE AND ASK A DOCTOR IF
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS?
- PRINCIPAL DISPLAY PANEL - 2 MG CAPLET BLISTER PACK CARTON
Loperamide Hydrochloride Product Label
The following document was submitted to the FDA by the labeler of this product Discount Drug Mart. 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.
Other
Drug Facts
DISTRIBUTED BY DRUG MART-FOOD FAIR
MEDINA, OHIO 44256 54
Active Ingredient (In Each Caplet)
Loperamide HCl USP, 2 mg
Purpose
Anti-diarrheal
Use
controls symptoms of diarrhea, including Travelers' Diarrhea
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
Otc - Do Not Use
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
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking antibiotics
Otc - When Using
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.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
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; ½ 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; ½ 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 between 20° – 25° C (68° – 77° F)
- see side panel for lot number and expiration date
- TAMPER EVIDENT: THIS PRODUCT PROTECTED WITH SEALED BLISTER UNITS. DO NOT USE IF ANY ARE TORN OR BROKEN.
Inactive Ingredients
anhydrous lactose, croscarmellose sodium, crospovidone, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, hydrogenated vegetable oil, magnesium stearate, powdered cellulose, pregelatinized starch
Questions?
call 1-800-406-7984
Principal Display Panel - 2 Mg Caplet Blister Pack Carton
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mart
FOOD FAIR
MAY CONTAIN
ANTI-THEFT
DEVICE
See New Warnings
and Directions
LOPERAMIDE HCl TABLETS USP, 2 mg
ANTI-DIARRHEAL
Anti-Diarrheal
Controls The
Symptoms Of Diarrhea
†COMPARE TO THE ACTIVE INGREDIENT OF IMODIUM® A-D *
12 Caplets*
Each caplet (*capsule-shaped tablet)
contains Loperamide HCl USP, 2 mg
* Please review the disclaimer below.