Active Ingredients (In Each 5 Ml Tsp)
Elm 65 mg
African Sea-coconut
FDA Label NDC 64272-736
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Luen Fook Medicine Sdn. Bhd. for the product African Sea-coconut (NDC 64272-736). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients (in each 5 ml tsp), purpose, use, warnings, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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 years | take 1 to 2 teaspoons (5-10mL) every 4 hours, not to exceed 12 teaspoons in 24 hours. |
| children under 6 years | consult 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)
Inner Glass Bottle Label
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Image Of Inner Glass Bottle Label (Bottle)
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