ANTI-DIARRHEAL- loperamide hcl tablet 
REMEDYREPACK INC.

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Active ingredient(in each caplet)

Loperamide HCI 2 mg

Purpose

Anti-diarrheal

Uses

  • 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 HCI


Do not use

  • if you have bloody or black stool

Ask a doctor before use if you have

  • fever
  • mucus present in your stool
  • a history of liver disease

Ask a doctor or pharmacist before use if you are

  • taking antibiotics

When using this product

  • tiredness, drowsiness or dizziness may occur. Be careful when driving or operating machinery.

Stop use and ask a doctor if

  • diarrhea lasts for more than 2 days
  • symptoms get worse
  • you get abdominal swelling
  • 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.

Directions

drink plenty of clear fluids to help prevent dehydration,which may accompany diarrhea

  • do not exceed recommended dose
  • Adults and children 12 years and over: 2 caplets after the first loose bowel movement; 1 caplet after each subsequent loose bowel movement; do not exceed 4 caplets in 24 hours
  • Children under 12 years: Ask a doctor

Other Information

  • TAMPER EVIDENT: Do not use if imprinted seal under cap is missing or broken.
  • store at 20⁰C-25⁰C (68⁰F-77⁰F)

Inactive Ingredients

cellulose, corn starch, D C Yellow #10, dicalcium phosphate, FD C Blue #1, magnesium stearate, silica gel

Questions or comments? call 1-800-540-3765

DRUG: Anti-Diarrheal

GENERIC: Loperamide HCl

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 61786-870-36

COLOR: green

SHAPE: CAPSULE

SCORE: Two even pieces

SIZE: 7 mm

IMPRINT: 44375

PACKAGING: 24 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

  • LOPERAMIDE HYDROCHLORIDE 2mg in 1

INACTIVE INGREDIENT(S):

  • ANHYDROUS DIBASIC CALCIUM PHOSPHATE
  • FD&C BLUE NO. 1
  • MAGNESIUM STEARATE
  • D&C YELLOW NO. 10
  • CELLULOSE, MICROCRYSTALLINE
  • SILICON DIOXIDE
  • STARCH, CORN

Remedy_Label

ANTI-DIARRHEAL 
loperamide hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61786-870(NDC:57896-381)
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
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STARCH, CORN (UNII: O8232NY3SJ)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Product Characteristics
Colorgreen (light green) Score2 pieces
ShapeCAPSULESize7mm
FlavorImprint Code 44375
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61786-870-3624 in 1 BLISTER PACK; Type 0: Not a Combination Product09/02/201609/02/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07649709/02/201609/02/2017
Labeler - REMEDYREPACK INC. (829572556)

Revised: 11/2018
 
REMEDYREPACK INC.