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Imodium - Loperamide Hydrochloride solution

Imodium - Loperamide Hydrochloride solution

Updated:2023年03月20日

Category
OTC
NDC CODE
50580-134-04,50580-134-08,50580-134-44
MARKETING STATUS
Active
APPROVAL STATUS
NDA
AHEAD PART

Drug Facts

ACTIVE INGREDIENT

Loperamide HCl 1 mg

INACTIVE INGREDIENT

anhydrous citric acid, caramel color, D&C yellow no. 10, FD&C blue no. 1, flavor, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, simethicone emulsion, sodium benzoate, sucralose, titanium dioxide, xanthan gum

INDICATIONS AND USAGE

controls symptoms of diarrhea, including Travelers' Diarrhea

PURPOSE

Anti-diarrheal

DOSAGE AND ADMINISTRATION
  • 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
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)

STORAGE AND HANDLING
  • each 30 mL contains: sodium 16 mg
  • store between 20-25°C (68-77°F)
  • do not use if outer neck band imprinted with "Imodium®" or inner neck band imprinted with "Sealed For Your Safety" is broken or missing
PACKAGE LABEL. PRINCIPAL DISPLAY PANEL

NDC 50580-134-08

Imodium ®

A-D

Loperamide HCl Oral Solution

Anti-Diarrheal

1 mg per 7.5 mL

Anti-Diarrheal

Oral Solution

Controls the symptoms

of diarrhea

8 fl oz

(240 mL)

Mint Flavor

imodium-01

QUESTIONS

call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)

包装企业

Johnson & Johnson Pharmaceutical Research

企业名称:Johnson & Johnson Pharmaceutical Research
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