IBS LABS - ANTI-DIARRHEAL ORIGINAL PRESCRIPTION STRENGTH, 2 MG- loperamide hydrochloride tablet 
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IBS LABS - ANTI-DIARRHEAL, LOPERAMIDE HCL, 2 MG (73581-777)

Active ingredient (in each caplet)

Loperamide HCl 2 mg

Purpose

Anti-diarrheal

Use

controls symptoms of diarrhea, including Travelers' Diarrhea

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 (1-800-222-1222) right away.

Directions

  • drink plenty of clear liquids to help prevent dehydration caused by diarrhea
  • find the right dose on chart. If possible, use weight to dose, otherwise use age.
adults and children 12 years and over2 caplets after the first loose stool, 1 caplet after each subsequent loose stool, but no more that 4 caplets in 24 hours
children 9-11 years (60-95 lbs)1 caplet after the first loose stool, 1/2 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, 1/2 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

  • store between 20° and 25°C (68° and 77°F)

Inactive ingredients

corn starch, D&C yellow #10 aluminum lake, dicalcium phosphate dihydrate, FD&C blue #1 brilliant blue lake, magnesium stearate,
microcrystalline cellulose, silica gel

Questions?

call toll-free 1-866-933-6337

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IBS LABS - ANTI-DIARRHEAL  ORIGINAL PRESCRIPTION STRENGTH, 2 MG
loperamide hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73581-777
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LOPERAMIDE HYDROCHLORIDE (UNII: 77TI35393C) (LOPERAMIDE - UNII:6X9OC3H4II) LOPERAMIDE HYDROCHLORIDE2 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)  
D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6)  
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Product Characteristics
Colorgreen (Light green) Score2 pieces
ShapeOVALSize10mm
FlavorImprint Code 44;375
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73581-777-9696 in 1 BOTTLE; Type 0: Not a Combination Product05/09/2023
2NDC:73581-777-20200 in 1 BOTTLE; Type 0: Not a Combination Product05/09/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07649705/09/2023
Labeler - YYBA (006339772)

Revised: 5/2023
 
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