AFRICAN SEA-COCONUT HERBAL MIXTURE- elm syrup

AFRICAN SEA-COCONUT by

Drug Labeling and Warnings

AFRICAN SEA-COCONUT by is a Otc medication manufactured, distributed, or labeled by LUEN FOOK MEDICINE SDN. BHD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 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

box.jpg

Inner Glass bottle label

bottle.jpg

INGREDIENTS AND APPEARANCE

AFRICAN SEA-COCONUT  HERBAL MIXTURE
elm syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64272-736
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Elm (UNII: 63POE2M46Y) (Elm - UNII:63POE2M46Y)	Elm	65 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
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
Shape		Size
Flavor	CHERRY (Natural Cherry Flavor) , LICORICE (Natural Licorice Flavor)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64272-736-01	1 in 1 BOX	11/01/2017
1		177 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	12/20/2011

Labeler - LUEN FOOK MEDICINE SDN. BHD. (652588989)