Active Ingredient
Loperamide HCl 2 mg
Stomach Relief Anti Diarrheal
FDA Label NDC 52904-443
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Select Corporation for the product Stomach Relief Anti Diarrheal (NDC 52904-443). 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, purpose, dosage, indications & usage, warnings, pregnancy, otc - keep out of reach of children, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Anti Diarrheal
Dosage
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
under 6 years (up to 47 lbs): ask a doctor
Indications & Usage
• controls the 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
• if you have bloody or black stool Ask a doctor before use
• if you have: • 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 for more than 2 days
• you get abdominal swelling or bulging.
These may be signs of a serious condition
Pregnancy
If pregnant or breast-feeding, ask a health
professional before use.
Otc - Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN.
Inactive Ingredient
Inactive
Ingredients: anhydrous lactose, croscarmellose sodium, crospovidone, DC yellow no. 10, FDC blue no. 1, hydrogenated vegetable oil, magnesium stearate, powdered cellulose, pregelatinized starch
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