Loperamide Hydrochloride

Loperamide Hydrochloride
SPL v3
SPL
SPL Set ID ae8237f0-95a6-4163-b476-25c0509ef151
Route
ORAL
Published
Effective Date 2023-06-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Loperamide (1 mg)
Inactive Ingredients
Anhydrous Citric Acid Carboxymethylcellulose Sodium, Unspecified D&c Yellow No. 10 Fd&c Blue No. 1 Glycerin Microcrystalline Cellulose Propylene Glycol Water Sodium Benzoate Sucralose Titanium Dioxide Xanthan Gum Dimethicone Silicon Dioxide

Identifiers & Packaging

Pill Appearance
Color: green
Marketing Status
ANDA Active Since 2020-05-18
Description

Mint Flavor 1 mg/7.5 mL 2 mg/15 mL For Hospital Use Only

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

Medication Information

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

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.

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
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

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

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

Structured Label Content

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.

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
Heart Alert (Heart alert)

Taking more than directed can cause serious heart problems or death

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

Allergy Alert (Allergy alert)

Do not use if you have ever had a rash or other allergic reaction to loperamide HCl

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

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:00:53.715897 · Updated: 2026-03-14T23:01:12.726296