SUPER COLON CLEANSE (SENNOSIDES) CAPSULE [HEALTH PLUS INC.]

SUPER COLON CLEANSE (SENNOSIDES) CAPSULE [HEALTH PLUS INC.]
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NDC 57348-897-10, 57348-897-12, 57348-897-24, 57348-897-60
Set ID f716e529-9634-4afd-8fb4-dee6c3be664c
Category HUMAN OTC DRUG LABEL
Packager Health Plus Inc.
Generic Name
Product Class
Product Number
Application Number PART334
  • Drug Facts

  • Active ingredient (per capsulle)

    Sennosides 8.3mg

    Purpose

    Stimulant Laxative

  • Use

    • relieves occasional constipation (irregularity)
    • generally produces a bowel movement in 6 to 12 hours
  • Warnings

    • Choking: Taking this product without adequate fluid may cause it to swell and block your throat or esophagus and may cause choking. Do not take this product if you have difficulty in swallowing. If you experience chest pain. vomiting or difficulty in swallowing or breathing after taking this product seek immediate medical attention

    Do not use

    • laxative products longer than 1 week unless directed by a doctor

    Ask a doctor before use if you have

    • stomach pain • nausea • vomiting • noticed a sudden change in bowel habits that continues for a period of 2 weeks.

    Stop use and ask a doctor if

    • you have rectal bleeding • you fail to have bowel movement after use of a laxative. These may indicale 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

    • take this product with a full glass (8oz) of water or other liquid. Taking this product without enough liquid may cause choking. (See choking warning.)
     adults and children 12 years of age and older: 2 capsules 2 times daily
     children 6 to under 12 years of age:  1 capsule once or twice daily 
     children under 6 years of age:  consult a doctor 

  • Other information

    • store below 86°F (30°C)

  • Inactive ingredients

    fennel seed powder, gelatin, lactobacillus acidophilus powder, papaya leaf powder, psyllium husk powder, rose hips fruit powder

  • Questions?

    1-800-822-6225

  • Super Colon Cleanse, 60ct (57348-897-60)

    label60

  • Super Colon Cleanse, 100ct(57348-897-10)

    Label100

  • Super Colon Cleanse, 120ct(57348-897-12)

    label 120

  • Super Colon Cleanse, 240ct(57348-897-24)

    label240

  • INGREDIENTS AND APPEARANCE
    SUPER COLON CLEANSE 
    sennosides capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57348-897
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES8.3 mg
    Inactive Ingredients
    Ingredient NameStrength
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    Product Characteristics
    ColorbrownScoreno score
    ShapeCAPSULESize16mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57348-897-601 in 1 CARTON09/16/2018
    160 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:57348-897-101 in 1 CARTON09/16/2018
    2100 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:57348-897-121 in 1 CARTON09/16/2018
    3120 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:57348-897-241 in 1 CARTON09/16/2018
    4240 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33409/16/2018
    Labeler - Health Plus Inc. (131279275)
    Registrant - Health Plus Inc. (131279275)
    Establishment
    NameAddressID/FEIBusiness Operations
    Health Plus Inc.131279275manufacture(57348-897)

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