ANTI DIARRHEAL- loperamide hydrochloride tablet, film coated 
REMEDYREPACK INC.

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Major Pharmaceuticals Anti-Diarrheal Drug Facts

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

  1. fever
  2. mucus in the stool
  3. 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

  1. symptoms get worse
  2. diarrhea lasts for more than 2 days
  3. 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).

Directions

  • 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.

adults and children

12 years and over

2 caplets after the first loose stool; 1 caplet after each subsequent loose stool; but no more than 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 at 20 °-25 °C (68 °-77 °F)
  • see end panel for lot number and expiration date

Inactive ingredients

anhydrous lactose, carnauba wax, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch

Questions or comments?

1-800-719-9260

DRUG: anti diarrheal

GENERIC: Loperamide Hydrochloride

DOSAGE: TABLET, FILM COATED

ADMINSTRATION: ORAL

NDC: 70518-0779-0

COLOR: green

SHAPE: OVAL

SCORE: Two even pieces

SIZE: 10 mm

IMPRINT: L2

PACKAGING: 12 in 1 CARTON

ACTIVE INGREDIENT(S):

  • LOPERAMIDE HYDROCHLORIDE 2mg in 1

INACTIVE INGREDIENT(S):

  • ANHYDROUS LACTOSE
  • MAGNESIUM STEARATE
  • CELLULOSE, MICROCRYSTALLINE
  • HYPROMELLOSES
  • CARNAUBA WAX
  • D&C YELLOW NO. 10
  • FD&C BLUE NO. 1
  • POLYETHYLENE GLYCOLS

Remedy_Label

ANTI DIARRHEAL 
loperamide hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70518-0779(NDC:0904-7725)
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 LACTOSE (UNII: 3SY5LH9PMK)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
Product Characteristics
ColorgreenScore2 pieces
ShapeOVALSize10mm
FlavorImprint Code L2
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70518-0779-012 in 1 CARTON; Type 0: Not a Combination Product10/11/201705/04/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07523210/11/201705/04/2020
Labeler - REMEDYREPACK INC. (829572556)

Revised: 5/2020
Document Id: a4d76444-bdbd-6129-e053-2a95a90adb9a
Set id: 1d41bfed-a8f3-410c-afba-b5d88a2681bf
Version: 4
Effective Time: 20200504
 
REMEDYREPACK INC.