FDA Label for Anti-diarrheal
View Indications, Usage & Precautions
Anti-diarrheal Product Label
The following document was submitted to the FDA by the labeler of this product Preferred Pharmaceuticals Inc.. 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 2 mg
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
Do not use
• if you have bloody or black stool• fever• mucus present in your stool• a history of liver disease• taking antibiotics• tiredness, drowsiness or dizziness may occur. Be careful when driving or operating machinery.• diarrhea lasts for more than 2 days• symptoms get worse• you get abdominal swelling• these may be signs of a serious condition
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, 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,which may accompany diarrhea
• do not exceed recommended dose• Adults and children 12 years and over: 2 caplets after the first loose bowel movement; 1 caplet after each subsequent loose bowel movement; do not exceed 4 caplets in 24 hours• Children under 12 years: Ask a doctor
Other Information
• TAMPER EVIDENT: Do not use if imprinted seal under cap is missing or broken.• store at 20⁰C-25⁰C (68⁰F-77⁰F)
Inactive Ingredients
cellulose, corn starch, D C Yellow #10, dicalcium phosphate, FD C Blue #1, magnesium stearate, silica gel
Otc - Questions
Questions or comments? call 1-800-540-3765
Package Label
NDC 68788-7369-2
GERICARE
Anti-Diarrheal
Loperamide HCl
Controls the symptoms of diarrhea
*compare to the active ingredient in imodium A-D
24 caplets
2 mg each
Tamper Evident: Do not use if imprinted seal under cap is broken or missing
Relabeled By: Preferred Pharmaceuticals Inc.
* Please review the disclaimer below.