Label: ONELAX SENNA- senna syrup

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 5, 2024

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  • Active Ingredient

    Active ingredient (in each teaspoonful)         Purpose
    Sennosides 8.8 mg …………………………................Laxative

  • Uses

    relieves occasional constipation (irregularity), generally causes bowel movement in 6 to 12 hours

  • Warnings

    ask a doctor before use if you have • stomach pain • nausea • vomiting • noticed a sudden change in bowel movements that continues over a period of 2 weeks

    Do not use laxative products for longer than 1 week unless directed by a doctor

    Ask a doctor or pharmacist before use if

    you are taking any other drug. Take this product two more hours before or after other drugs. Laxatives may affect how other drugs work.

    Stop use and ask a doctor if

    you have rectal bleeding or fail to have bowel movement after use of laxative. This may indicate 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 preferably at bedtime or as directed by a doctor. Shake Well Before Using.

  • DOSAGE & ADMINISTRATION

     age starting dose maximum dosage
     Adults and children 12 yeart and older 2-3 teaspoons once a day 3 teaspoons twice a day
     Children 6 years to under 12 yeart 1 - 1 1/2 teaspoons once a day 11/2 teaspoons twice a day
     Children 2 years to under 6 yeartl/2 - 3/4 teaspoon once a day 3/4 teaspoon twice a day
     Children under 2 years ask a doctor ask a doctor

  • Other Information

    • Avoid accessive heat. Store at room temperature 15°-30°C (59°-86°F)
  • Inactive Ingredients

    flavor choclate, mythylparaben, propylene glycol, propylparaben, purified water and sucrose

  • KEEP OUT OF REACH OF CHILDREN SECTION

    In case of accidental overdose, get medical help or contact a Poison Control Center immediately

    Questions?

    To Report Adverse Drug Event Call 1(877) 225-6999

    DISTRIBUTED BY:

    ATLANTIC BIOLOGICALS CORP.

    MIAMI, FL 33179

  • PRINCIPAL DISPLAY PANEL

    LABEL 1

    LABEL 2

    LABEL 3

  • INGREDIENTS AND APPEARANCE
    ONELAX SENNA 
    senna syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17856-1127(NDC:71399-0027)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SENNOSIDES A AND B (UNII: 1B5FPI42EN) (SENNOSIDES A AND B - UNII:1B5FPI42EN) SENNOSIDES A AND B417.12 mg  in 237 mL
    Inactive Ingredients
    Ingredient NameStrength
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHOCOLATEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17856-1127-1120 in 1 BOX, UNIT-DOSE03/05/2024
    1NDC:17856-1127-52.5 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    2NDC:17856-1127-272 in 1 BOX, UNIT-DOSE03/05/2024
    2NDC:17856-1127-65 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    3NDC:17856-1127-372 in 1 BOX, UNIT-DOSE03/05/2024
    3NDC:17856-1127-710 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    4NDC:17856-1127-472 in 1 BOX, UNIT-DOSE03/05/2024
    4NDC:17856-1127-815 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00702/06/2024
    Labeler - ATLANTIC BIOLOGICALS CORP. (047437707)
    Registrant - ATLANTIC BIOLOGICALS CORP. (047437707)
    Establishment
    NameAddressID/FEIBusiness Operations
    UNIT DOSE SOLUTION360804194repack(17856-1127)
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