Active Ingredient (In Each Caplet)
Loperamide Hydrochloride 2 mg
Handy Solutions Anti-diarrheal Tablet
FDA Label NDC 67751-162
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Navajo Manufacturing Company Inc. for the product Handy Solutions Anti-diarrheal (NDC 67751-162). 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, 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, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antidiarrheal
Uses
Controls the symptoms of diarrhea, including Traveler’s diarrhea
Warnings
Allergy alert: Do not use if you have ever had a rash or other allergic reaction to Loperamide HCl.
Do Not Use
• if you have bloody or black stools
Ask A Doctor Before Use If You Have
• a fever
• mucus in 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
• symptoms get worse
• diarrhea lasts more than 2 days
• you get abdominal swelling or bulging. These may be signs of a serious condition.
If You Are Pregnant Or Breast Feeding,
ask a health professional before use.
Keep This And All Drugs Out Of The Reach Of Children.
In case of accidental overdose, contact a physician or Poison Control Center right away.
Directions
do not use more than directed
drink plenty of clear fluids to help prevent dehydration caused by diarrhea
| Adults and children (12 years and older): | Take 2 caplets after the first
loose bowel movement followed by 1 caplet after each subsequent loose bowel movement but no more than 4 caplets in 24 hours. |
| Children under 12 years: | Do not give to children under
12 years of age. |
Other Information
• store between 68° - 77°F (20° - 25°C)
• tamper-evident sealed packets
• do not use any opened or torn packet
Inactive Ingredients
anhydrous lactose, croscarmellose sodium, crospovidone, D&C yellow # 10, FD&C blue # 1, hydrogenated vegetable oil, magnesium stearate, powdered cellulose, pregelatinized starch
Questions Or Comments?
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