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  5. Label Information: African Sea-coconut Herbal Mixture

FDA Label for African Sea-coconut Herbal Mixture

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS (IN EACH 5 ML TSP)
    2. PURPOSE
    3. USE
    4. WARNINGS
    5. OTC - STOP USE
    6. OTC - PREGNANCY OR BREAST FEEDING
    7. OTC - KEEP OUT OF REACH OF CHILDREN
    8. DIRECTIONS
    9. OTHER INFORMATION
    10. INACTIVE INGREDIENTS
    11. QUESTIONS?
    12. OUTER BOX LABEL
    13. INNER GLASS BOTTLE LABEL

African Sea-coconut Herbal Mixture Product Label

The following document was submitted to the FDA by the labeler of this product Luen Fook Medicine Sdn. Bhd.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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


Otc - Stop Use



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.


Otc - Pregnancy Or Breast Feeding



If pregnant or breast-feeding, ask a health professional before use.


Otc - Keep Out Of Reach Of Children



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



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image of outer box - box

image of outer box - box


Inner Glass Bottle Label



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image of inner glass bottle label - bottle

image of inner glass bottle label - bottle


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