GOOD SENSE ANTI DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [PROFICIENT RX LP]

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  • GOOD SENSE ANTI DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [PROFICIENT RX LP]

GOOD SENSE ANTI DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [PROFICIENT RX LP]
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NDC 71205-079-12
Set ID 345be8d9-4fc9-40a2-a9f3-775d48beb85b
Category HUMAN OTC DRUG LABEL
Packager Proficient Rx LP
Generic Name
Product Class
Product Number
Application Number ANDA075232
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  • 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

    1.
    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

    1.
    store at 20°-25°C (68°-77°F)
    2.
    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

  • Principal Display Panel

    Anti-Diarrheal

    See New Warnings and Directions

    Loperamide Hydrochloride Tablets, 2 mg

    Anti-Diarrheal

    Controls the Symptoms of Diarrhea

    Actual Size

    Compare to active ingredient of Imodium® A-D

    100% SATISFACTION GUARANTEED

    12 Caplets*

    *Capsule-Shaped Tablets

    Relabeled by:

    Proficient Rx LP

    Thousand Oaks, CA 91320

    71205-079-12
  • INGREDIENTS AND APPEARANCE
    GOOD SENSE ANTI DIARRHEAL 
    loperamide hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71205-079(NDC:0113-0224)
    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)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    ColorGREENScore2 pieces
    ShapeOVALSize10mm
    FlavorImprint Code L2
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71205-079-1212 in 1 CARTON08/01/2018
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07523202/25/2003
    Labeler - Proficient Rx LP (079196022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Proficient Rx LP079196022RELABEL(71205-079)
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