Label: AFRICAN SEA-COCONUT HERBAL MIXTURE- elm syrup

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated June 26, 2017

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  • Active ingredients (in each 5 mL tsp)

    Elm 65 mg

  • Purpose

    Demulcent

  • Use

    for the temporary relief of minor discomfort and protection of irritated areas in sore mouth and sore throat.

  • WARNINGS

    Warnings

    Stop use and ask a doctor if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting. If sore mouth symptoms do not improve in 7 days, see your doctor promptly.  These could 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

    • use only as directed
    adults and children 12 years and older
    		take orally 2 to 4 teaspoons (10-20mL) every 4 hours, not to exceed 24 teaspoons in 24 hours.
    children 6 to under 12 yearstake 1 to 2 teaspoons (5-10mL) every 4 hours, not to exceed 12 teaspoons in 24 hours.
    children under 6 yearsconsult a doctor before use.
  • Other Information

    store at 20-25∘C (68-77∘F)

  • Inactive Ingredients

    ammonium acetate, benzoic acid, caramel, ipecac, licorice, menthol,  drimia Indica bulb, sodium benzoate, sucrose, tolu balsam, prunus serotina bark.

  • Questions?

    Call weekdays from 9 AM-5 PM PST at 1-877-889-8968.

  • Outer box label

    box.jpg

    image of outer box

  • Inner Glass bottle label

    bottle.jpg

    image of inner glass bottle label

  • INGREDIENTS AND APPEARANCE
    AFRICAN SEA-COCONUT  HERBAL MIXTURE
    elm syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64272-736
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Elm (UNII: 63POE2M46Y) (Elm - UNII:63POE2M46Y) Elm65 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    Ammonium Acetate (UNII: RRE756S6Q2)  
    Benzoic Acid (UNII: 8SKN0B0MIM)  
    Caramel (UNII: T9D99G2B1R)  
    Ipecac (UNII: 62I3C8233L)  
    Licorice (UNII: 61ZBX54883)  
    Menthol (UNII: L7T10EIP3A)  
    Drimia Indica Bulb (UNII: IQ3O648R19)  
    Sodium Benzoate (UNII: OJ245FE5EU)  
    Sucrose (UNII: C151H8M554)  
    Tolu balsam (UNII: TD2LE91MBE)  
    Prunus Serotina Bark (UNII: 5D48E975HA)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRY (Natural Cherry Flavor) , LICORICE (Natural Licorice Flavor) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64272-736-011 in 1 BOX11/01/2017
    1177 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35612/20/2011
    Labeler - LUEN FOOK MEDICINE SDN. BHD. (652588989)
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