topcare loperamide hydrochloride
loperamide HCl · Solution · Oral
Active ingredient
Active ingredient (in each 7.5 mL) Loperamide HCl 1 mg
Purpose
Purpose Anti-diarrheal
Uses
Use controls symptoms of diarrhea, including Travelers’ Diarrhea
Warnings
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 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. 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).
Do not use
Do not use if you have bloody or black stool
Ask a doctor before use
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
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
When using this product tiredness, drowsiness or dizziness may occur. Be careful when driving or operating machinery.
Stop use and ask a doctor
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 or breast-feeding
If pregnant or breast-feeding, ask a health professional before use.
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 (1-800-222-1222).
Directions
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.
• shake well before using
• use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.
• mL = milliliter adults and children 12 years and over 30 mL after the first loose stool; 15 mL after each subsequent loose stool; but no more than 60 mL in 24 hours children 9-11 years (60-95 lbs) 15 mL after the first loose stool; 7.5 mL after each subsequent loose stool; but no more than 45 mL in 24 hours children 6-8 years (48-59 lbs) 15 mL after the first loose stool; 7.5 mL after each subsequent loose stool; but no more than 30 mL 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
Other information
• each 30 mL contains: sodium 15 mg
• store between 20-25 ° C (68-77 ° F)
Inactive ingredients
Inactive ingredients anhydrous citric acid, carboxymethylcellulose sodium, D&C yellow no. 10, FD&C blue no. 1, glycerin, microcrystalline cellulose, natural and artificial mint flavor, propylene glycol, purified water, simethicone, sodium benzoate, sucralose, titanium dioxide, xanthan gum
Questions?
Questions or comments? 1-888-423-0139
Label text from the FDA structured product label by Topco Associates LLC (revised Apr 1, 2025). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Loperamide Hydrochloride in 1 product
topcare loperamide hydrochloride NDC products (1)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 36800-583 | Loperamide Hydrochloride 1 mg/7.5mL Solution | Topco Associates LLC | ANDA |
Frequently asked questions
What is topcare loperamide hydrochloride used for?
Use controls symptoms of diarrhea, including Travelers’ Diarrhea
Who makes topcare loperamide hydrochloride?
topcare loperamide hydrochloride is listed by 1 labeler in the FDA NDC directory, including Topco Associates LLC.