Label: AFRICAN SEA-COCONUT HERBAL MIXTURE- elm syrup
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Contains inactivated NDC Code(s)
NDC Code(s): 64272-736-01 - Packager: LUEN FOOK MEDICINE SDN. BHD.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated June 26, 2017
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients (in each 5 mL tsp)
- Purpose
- Use
- WARNINGS
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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
- Inactive Ingredients
- Questions?
- Outer box label
- Inner Glass bottle label
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INGREDIENTS AND APPEARANCE
AFRICAN SEA-COCONUT HERBAL MIXTURE
elm syrupProduct 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)