AFRICAN SEA-COCONUT

Manufacturer
LUEN FOOK MEDICINE SDN. BHD.
Effective date
2017-06-26
Label type
HUMAN OTC DRUG LABEL
Version
13
Source
full-release
Hydrated at
2026-05-31 22:52:55

Label at a glance#

ProductAFRICAN SEA-COCONUT Herbal Mixture
Active ingredientElm
Label structure10 sections

Dosage and administration

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.

Storage and handling

store at 20-25 ∘ C (68-77 ∘ F)

Label contents#

Full prescribing information#

Active ingredients (in each 5 mL tsp)

OTC - ACTIVE INGREDIENT SECTION

Elm 65 mg

Purpose

OTC - PURPOSE SECTION

Demulcent

Use

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

Warnings

OTC - STOP USE SECTION

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 SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

store at 20-25∘C (68-77∘F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

Questions?

OTC - QUESTIONS SECTION

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

Outer box label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

box.jpg

image of outer boximage of outer box

Inner Glass bottle label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

bottle.jpg

image of inner glass bottle labelimage of inner glass bottle label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64272-736-012020-01-31C16284748780-19d75b9d0-4282-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64272-736-01AFRICAN SEA-COCONUTHerbal Mixture1 in 1 BOXSYRUP113
64272-736-01AFRICAN SEA-COCONUTHerbal Mixture177 mL in 1 BOTTLE, GLASSSYRUP17713

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64272-736AFRICAN SEA-COCONUT HERBAL MIXTURE (ELM) SYRUP [LUEN FOOK MEDICINE SDN. BHD.]13Legacy NDC, 2 package rows20171108_8a3b1cb1-0112-4cdb-8545-8fc7e325a7be.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ElmACTIVE INGREDIENT63POE2M46Y3
ElmACTIVE MOIETY63POE2M46Y3
Ammonium AcetateINACTIVE INGREDIENTRRE756S6Q23
Benzoic AcidINACTIVE INGREDIENT8SKN0B0MIM3
CaramelINACTIVE INGREDIENTT9D99G2B1R3
Drimia Maritima BulbINACTIVE INGREDIENT3629601H5D3
IpecacINACTIVE INGREDIENT62I3C8233L3
LicoriceINACTIVE INGREDIENT61ZBX548833
MentholINACTIVE INGREDIENTL7T10EIP3A3
Prunus Serotina BarkINACTIVE INGREDIENT5D48E975HA3
Sodium BenzoateINACTIVE INGREDIENTOJ245FE5EU3
SucroseINACTIVE INGREDIENTC151H8M5543
Tolu balsamINACTIVE INGREDIENTTD2LE91MBE3

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64272-73664272-736-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 3 · 141 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
MentholMENTHOLL7T10EIP3ACAPSULE / ORAL0.87 mgExact identifier — unii candidate
24 equally ranked IID candidates
Sodium BenzoateSODIUM BENZOATEOJ245FE5EUFILM / BUCCAL1 mgExact identifier — unii candidate
35 equally ranked IID candidates
SucroseSUCROSEC151H8M554INJECTION, EMULSION / INTRAVENOUS970 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS900 mgExact identifier — unii candidate
48 equally ranked IID candidates
Sodium BenzoateSODIUM BENZOATEOJ245FE5EUTABLET, COATED / ORAL0.2 mgExact identifier — unii candidate
35 equally ranked IID candidates
Benzoic AcidBENZOIC ACID8SKN0B0MIMGEL / TOPICAL0.1 %w/wExact identifier — unii candidate
23 equally ranked IID candidates
Benzoic AcidBENZOIC ACID8SKN0B0MIMINJECTION, SOLUTION / INTRAMUSCULAR0.2 %w/vExact identifier — unii candidate
23 equally ranked IID candidates
Sodium BenzoateSODIUM BENZOATEOJ245FE5EUELIXIR / ORAL5.02 mg/5mlExact identifier — unii candidate
35 equally ranked IID candidates
Sodium BenzoateSODIUM BENZOATEOJ245FE5EUSUSPENSION / ORAL320 mgExact identifier — unii candidate
35 equally ranked IID candidates
Sodium BenzoateSODIUM BENZOATEOJ245FE5EUPASTE / DENTAL0.08 %w/wExact identifier — unii candidate
35 equally ranked IID candidates
Benzoic AcidBENZOIC ACID8SKN0B0MIMSUPPOSITORY / VAGINAL2 mgExact identifier — unii candidate
23 equally ranked IID candidates
MentholMENTHOLL7T10EIP3APASTE, DENTIFRICE / DENTAL4.7 %w/wExact identifier — unii candidate
24 equally ranked IID candidates
Benzoic AcidBENZOIC ACID8SKN0B0MIMTABLET, COATED / ORALNAExact identifier — unii candidate
23 equally ranked IID candidates
SucroseSUCROSEC151H8M554INJECTION, SOLUTION / INTRAVENOUSNAExact identifier — unii candidate
48 equally ranked IID candidates
Sodium BenzoateSODIUM BENZOATEOJ245FE5EUSYSTEM / TOPICAL2 mgExact identifier — unii candidate
35 equally ranked IID candidates
SucroseSUCROSEC151H8M554POWDER / ORAL27768 mgExact identifier — unii candidate
48 equally ranked IID candidates
MentholMENTHOLL7T10EIP3ASUSPENSION / ORAL1 mgExact identifier — unii candidate
24 equally ranked IID candidates
MentholMENTHOLL7T10EIP3ACREAM / TOPICAL0.1 %w/wExact identifier — unii candidate
24 equally ranked IID candidates
MentholMENTHOLL7T10EIP3ASOLUTION / ORAL3 mgExact identifier — unii candidate
24 equally ranked IID candidates
Sodium BenzoateSODIUM BENZOATEOJ245FE5EUGRANULE, EFFERVESCENT / ORAL60 mgExact identifier — unii candidate
35 equally ranked IID candidates
SucroseSUCROSEC151H8M554PASTILLE / ORAL426 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554INJECTION / INTRAVENOUS1950 mgExact identifier — unii candidate
48 equally ranked IID candidates
MentholMENTHOLL7T10EIP3ATABLET, ORALLY DISINTEGRATING / ORAL14 mgExact identifier — unii candidate
24 equally ranked IID candidates
SucroseSUCROSEC151H8M554TABLET / BUCCAL109 mgExact identifier — unii candidate
48 equally ranked IID candidates
CaramelCARAMELT9D99G2B1RSOLUTION / RECTALNAExact identifier — unii candidate
9 equally ranked IID candidates
MentholMENTHOLL7T10EIP3ASOAP / TOPICAL0.75 %w/wExact identifier — unii candidate
24 equally ranked IID candidates
CaramelCARAMELT9D99G2B1RGRANULE, FOR SUSPENSION / ORAL2.5 mg/5mlExact identifier — unii candidate
9 equally ranked IID candidates
Sodium BenzoateSODIUM BENZOATEOJ245FE5EUPASTE, DENTIFRICE / DENTAL0.5 %w/wExact identifier — unii candidate
35 equally ranked IID candidates
SucroseSUCROSEC151H8M554SYRUP / ORAL46400 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554GRANULE / ORALNAExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554CAPSULE, COATED PELLETS / ORAL59.8 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554CAPSULE, COATED, EXTENDED RELEASE / ORAL86 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554TABLET / ORAL4249 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554SUSPENSION/ DROPS / ORAL3750 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554INJECTION, SUSPENSION, LIPOSOMAL / INTRAVENOUS9.4 %w/vExact identifier — unii candidate
48 equally ranked IID candidates
Benzoic AcidBENZOIC ACID8SKN0B0MIMTABLET, FILM COATED / ORALNAExact identifier — unii candidate
23 equally ranked IID candidates
Sodium BenzoateSODIUM BENZOATEOJ245FE5EUSOLUTION / ORAL660 mgExact identifier — unii candidate
35 equally ranked IID candidates
CaramelCARAMELT9D99G2B1RSUSPENSION / ORAL111.12 mg/5mlExact identifier — unii candidate
9 equally ranked IID candidates
Sodium BenzoateSODIUM BENZOATEOJ245FE5EUINJECTION / INTRAMUSCULAR864 mgExact identifier — unii candidate
35 equally ranked IID candidates
Benzoic AcidBENZOIC ACID8SKN0B0MIMSUSPENSION / ORAL15 mgExact identifier — unii candidate
23 equally ranked IID candidates
MentholMENTHOLL7T10EIP3AGEL / TOPICAL0.1 %w/wExact identifier — unii candidate
24 equally ranked IID candidates
SucroseSUCROSEC151H8M554CAPSULE, DELAYED RELEASE / ORAL955 mgExact identifier — unii candidate
48 equally ranked IID candidates
CaramelCARAMELT9D99G2B1RLOTION / TOPICALNAExact identifier — unii candidate
9 equally ranked IID candidates
CaramelCARAMELT9D99G2B1RLIQUID / ORAL5.3 mgExact identifier — unii candidate
9 equally ranked IID candidates
MentholMENTHOLL7T10EIP3ASOLUTION / DENTALNAExact identifier — unii candidate
24 equally ranked IID candidates
SucroseSUCROSEC151H8M554ELIXIR / ORAL18000 mgExact identifier — unii candidate
48 equally ranked IID candidates
Sodium BenzoateSODIUM BENZOATEOJ245FE5EUSPONGE / TOPICALNAExact identifier — unii candidate
35 equally ranked IID candidates
Benzoic AcidBENZOIC ACID8SKN0B0MIMSOLUTION / TOPICAL0.1 %w/wExact identifier — unii candidate
23 equally ranked IID candidates
MentholMENTHOLL7T10EIP3ASYRUP / ORAL7.5 mg/5mlExact identifier — unii candidate
24 equally ranked IID candidates
SucroseSUCROSEC151H8M554DROPS / ORALNAExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554TABLET, FILM COATED / ORAL145 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554LOZENGE / TRANSMUCOSAL1255 mgExact identifier — unii candidate
48 equally ranked IID candidates
Benzoic AcidBENZOIC ACID8SKN0B0MIMMOUTHWASH / BUCCALNAExact identifier — unii candidate
23 equally ranked IID candidates
Sodium BenzoateSODIUM BENZOATEOJ245FE5EUGRANULE / ORALNAExact identifier — unii candidate
35 equally ranked IID candidates
Sodium BenzoateSODIUM BENZOATEOJ245FE5EUTABLET, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
35 equally ranked IID candidates
Sodium BenzoateSODIUM BENZOATEOJ245FE5EUSYRUP / ORAL80 mgExact identifier — unii candidate
35 equally ranked IID candidates
Sodium BenzoateSODIUM BENZOATEOJ245FE5EUSOLUTION / TOPICAL0.1 %w/vExact identifier — unii candidate
35 equally ranked IID candidates
Benzoic AcidBENZOIC ACID8SKN0B0MIMSOLUTION / IRRIGATION0.02 %w/vExact identifier — unii candidate
23 equally ranked IID candidates
MentholMENTHOLL7T10EIP3ADROPS / OPHTHALMICNAExact identifier — unii candidate
24 equally ranked IID candidates
SucroseSUCROSEC151H8M554INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS2000 mgExact identifier — unii candidate
48 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
5c4ad00b-4bb0-46e2-a3da-d8613166cb4c8a3b1cb1-0112-4cdb-8545-8fc7e325a7be2017-06-26WarningsExact identifier
spl id: 5c4ad00b-4bb0-46e2-a3da-d8613166cb4c
spl set id: 8a3b1cb1-0112-4cdb-8545-8fc7e325a7be

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.