Active Ingredients (In Each Caplet)
Loperamide HCl 2 mg
Simethicone 125 mg
Foster And Thrive Anti Diarrheal Anti Gas Tablet
FDA Label NDC 70677-1105
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Strategic Sourcing Services Llc for the product Foster And Thrive Anti Diarrheal Anti Gas (NDC 70677-1105). 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 ingredients (in each caplet), purposes, 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
Purposes
Anti-diarrheal
Anti-gas
Uses
relieves symptoms of diarrhea plus bloating, pressure and cramps, commonly referred to as gas
Warnings
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
Do Not Use
- if you have bloody or black stool
- if you have difficulty swallowing
Ask A Doctor Before Use If You Have
- fever
- mucus in the stool
- a history of liver disease
- a history of abnormal heart rhythm
Ask A Doctor Or Pharmacist Before Use If You Are
taking a prescription drug. Loperamide may interact with certain prescription drugs.
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.
- you have difficulty swallowing the caplet
If Pregnant Or Breast-Feeding,
ask a health professional before use.
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
- take only on an empty stomach (1 hour before or 2 hours after a meal)
- take with a full (8 oz.) glass of water
- find right dose on chart below. 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
- each caplet contains: calcium 165 mg, sodium 3 mg
- store between 20°-25°C (68°-77°F). Protect from light.
- Do not use if printed blister unit is broken or torn
Inactive Ingredients
acesulfame potassium, croscarmellose sodium, dibasic calcium phosphate, maltodextrin, microcrystalline cellulose, natural and artificial flavor, propylene glycol, stearic acid
Questions Or Comments?
Call 833-358-6431 Monday to Friday 9:00am to 7:00pm EST
Package/Label Principal Display Panel
COMPARE TO IMODIUM® MULTI-SYMPTOM RELIEF ACTIVE INGREDIENTS
Foster & Thrive™
MULTI-SYMPTOM RELIEF CAPLET
Loperamide Hydrochloride and Simethicone tablets, 2 mg/125mg
Anti-Diarrheal
Anti-Gas
ACTUAL SIZE
Relieves symptoms of diarrhea plus:
• Cramps & Pressure
• Bloating • Gas
12 CAPLETS*
*CAPSULE-SHAPED TABLETS
Anti-diarrheal Anti-gas -image (Image 01)
* Please review the disclaimer below.
