loperamide hydrochloride
0d1eb0dc-991b-4e54-bae1-3660bddc6243
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Purpose
Anti-diarrheal
How Supplied
NDC 68094-029-62 7.5 mL per unit dose cup Thirty (30) cups per shipper NDC 68094-129-62 15 mL per unit dose cup Thirty (30) cups per shipper
Description
Mint Flavor 1 mg/7.5 mL 2 mg/15 mL For Hospital Use Only
Medication Information
Purpose
Anti-diarrheal
Directions
- Use as directed per healthcare professional.
- 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
- 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
- each 30 mL contains: sodium 15 mg
- store between 20-25°C (68-77°F)
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
How Supplied
NDC 68094-029-62
7.5 mL per unit dose cup
Thirty (30) cups per shipper
NDC 68094-129-62
15 mL per unit dose cup
Thirty (30) cups per shipper
Description
Mint Flavor 1 mg/7.5 mL 2 mg/15 mL For Hospital Use Only
Use
controls symptoms of diarrhea, including Travelers' Diarrhea
Read complete directions and warnings before using.
Section 42229-5
Mint Flavor
1 mg/7.5 mL 2 mg/15 mL
For Hospital Use Only
Section 50565-1
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)
Section 50567-7
When using this product tiredness, drowsiness or dizziness may occur. Be careful when driving or operating machinery.
Section 50568-5
Ask a doctor or pharmacist before use if you are taking antibiotics
Section 50570-1
Do not use if you have bloody or black stool
Section 53413-1
For inquiries call Precision Dose, Inc. at 1-800-397-9228 or email [email protected]
Section 53414-9
If pregnant or breast-feeding, ask a health professional before use.
Heart Alert
Taking more than directed can cause serious heart problems or death
Allergy Alert
Do not use if you have ever had a rash or other allergic reaction to loperamide HCl
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.
Active Ingredient (in Each 7.5 Ml)
Loperamide HCl 1 mg
Ask A Doctor Before Use If You Have
- fever
- mucus in the stool
- a history of liver disease
Principal Display Panel 2 Mg/15 Ml Cup Lid Label
NDC 68094-129-59
PrecisionDose™
LOPERAMIDE Hydrochloride
Oral SOLUTION
2 mg/15 mL
Shake Well Delivers 15 mL Gluten Free
Contains 7.5 mg Sodium Hospital Use Only
Store at 20°-25°C (68°-77°F)
Pkg. By: Precision Dose, Inc.
S. Beloit, IL 61080
1253 R1
Principal Display Panel 1 Mg/7.5 Ml Cup Lid Label
NDC 68094-029-59
PrecisionDose™
LOPERAMIDE Hydrochloride
Oral SOLUTION
1 mg/7.5 mL
Shake Well Delivers 7.5 mL Gluten Free
Contains 3.75 mg Sodium Hospital Use Only
Store at 20°-25°C (68°-77°F)
Pkg. By: Precision Dose, Inc.
S. Beloit, IL 61080
1252 R1
Structured Label Content
Purpose
Anti-diarrheal
Directions
- Use as directed per healthcare professional.
- 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
- 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
How Supplied
NDC 68094-029-62
7.5 mL per unit dose cup
Thirty (30) cups per shipper
NDC 68094-129-62
15 mL per unit dose cup
Thirty (30) cups per shipper
Use
controls symptoms of diarrhea, including Travelers' Diarrhea
Read complete directions and warnings before using.
Section 42229-5 (42229-5)
Mint Flavor
1 mg/7.5 mL 2 mg/15 mL
For Hospital Use Only
Section 50565-1 (50565-1)
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)
Section 50567-7 (50567-7)
When using this product tiredness, drowsiness or dizziness may occur. Be careful when driving or operating machinery.
Section 50568-5 (50568-5)
Ask a doctor or pharmacist before use if you are taking antibiotics
Section 50570-1 (50570-1)
Do not use if you have bloody or black stool
Section 53413-1 (53413-1)
For inquiries call Precision Dose, Inc. at 1-800-397-9228 or email [email protected]
Section 53414-9 (53414-9)
If pregnant or breast-feeding, ask a health professional before use.
Heart Alert (Heart alert)
Taking more than directed can cause serious heart problems or death
Allergy Alert (Allergy alert)
Do not use if you have ever had a rash or other allergic reaction to loperamide HCl
Stop Use and Ask A Doctor If (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.
Active Ingredient (in Each 7.5 Ml) (Active ingredient (in each 7.5 mL))
Loperamide HCl 1 mg
Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
- fever
- mucus in the stool
- a history of liver disease
Principal Display Panel 2 Mg/15 Ml Cup Lid Label (PRINCIPAL DISPLAY PANEL - 2 mg/15 mL Cup Lid Label)
NDC 68094-129-59
PrecisionDose™
LOPERAMIDE Hydrochloride
Oral SOLUTION
2 mg/15 mL
Shake Well Delivers 15 mL Gluten Free
Contains 7.5 mg Sodium Hospital Use Only
Store at 20°-25°C (68°-77°F)
Pkg. By: Precision Dose, Inc.
S. Beloit, IL 61080
1253 R1
Principal Display Panel 1 Mg/7.5 Ml Cup Lid Label (PRINCIPAL DISPLAY PANEL - 1 mg/7.5 mL Cup Lid Label)
NDC 68094-029-59
PrecisionDose™
LOPERAMIDE Hydrochloride
Oral SOLUTION
1 mg/7.5 mL
Shake Well Delivers 7.5 mL Gluten Free
Contains 3.75 mg Sodium Hospital Use Only
Store at 20°-25°C (68°-77°F)
Pkg. By: Precision Dose, Inc.
S. Beloit, IL 61080
1252 R1
Advanced Ingredient Data
Raw Label Data
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Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:06:29.871131 · Updated: 2026-03-14T23:09:18.179019