Active Ingredient(In Each Caplet)
Loperamide HCI 2 mg
Anti-diarrheal Tablet
FDA Label NDC 67296-2314
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Redpharm Drug for the product Anti-diarrheal (NDC 67296-2314). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient(in each caplet), purpose, uses, warnings, otc - keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Anti-diarrheal
Uses
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
Heart alert:Taking more than directed can cause serious heart problems or death.
Do not useif you have bloody or black stool
Ask a doctor before use if you have
- a fever
- mucus present in your stool
- a history of liver disease
- a history of abnormal heart rhythm
- diarrhea lasts for more than 2 days
- symptoms get worse
- you get abdominal swelling or bulging.
Ask a doctor or pharmacist before use if you aretaking a prescription drug. Loperamide may interact with certain
prescription drugs.
When using this producttiredness, drowsiness or dizziness may occur. Be careful when driving or operating machinery.
Stop use and ask a doctor if
These may be signs of a serious condition.
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.
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 (34-47 lbs) | ask a doctor |
| children under 2 years (up to 33 lbs) | do not use |
Other Information
- each caplet contains:calcium 15 mg
- TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
- store at 20⁰C-25⁰C (68⁰F-77⁰F)
- see end flap for expiration date and lot number
Inactive Ingredients
corn starch, D&C yellow #10 aluminum lake, dibasic calcium phosphate dihydrate,
FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, silicon dioxide
Questions Or Comments?
call 1-800-540-3765
Package Label
1 (381 25)
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