AFRICAN SEA-COCONUT HERBAL MIXTURE- elm syrup 
LUEN FOOK MEDICINE SDN. BHD.

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.

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Drug Facts

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

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

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 20-25C (68-77F)

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

Inner Glass bottle label

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image of inner glass bottle label

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)

Revised: 6/2017
Document Id: 5c4ad00b-4bb0-46e2-a3da-d8613166cb4c
Set id: 8a3b1cb1-0112-4cdb-8545-8fc7e325a7be
Version: 13
Effective Time: 20170626
 
LUEN FOOK MEDICINE SDN. BHD.