Label: UMCKA MENTHOL- pelargonium sidoides syrup
- NDC Code(s): 53499-5272-5, 53499-5272-9
- Packager: Schwabe North America, Inc
- Category: HUMAN OTC DRUG LABEL
DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.
Drug Label Information
Updated October 26, 2023
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- Official Label (Printer Friendly)
- Active Ingredient
- Inactive Ingredient
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Dosage & Administration
Directions
For best results, use at first sign of symptoms.
Continue to use for an additional 48 hours after symptoms cease.
Use only with enclosed dosage cup.
Adults & children 12 years of age and older: Take 1 1/2 teaspoon (tsp) (7.5 mL) 3 times daily.
Children under 12 years of age: Consult a physician.
- Indications & Usage
- Purpose
- Warnings
- Ask Doctor
- Stop Use
- Pregnancy or Breast Feeding
- Keep out of reach of children.
- Overdose
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
UMCKA MENTHOL
pelargonium sidoides syrupProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53499-5272 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PELARGONIUM SIDOIDES ROOT (UNII: H6J53HEX8E) (PELARGONIUM SIDOIDES ROOT - UNII:H6J53HEX8E) PELARGONIUM SIDOIDES ROOT 1 [hp_X] in 120 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) FRUCTOSE (UNII: 6YSS42VSEV) MENTHOL (UNII: L7T10EIP3A) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) MALTODEXTRIN (UNII: 7CVR7L4A2D) Product Characteristics Color Score Shape Size Flavor MENTHOL (NATURAL MENTHOL FLAVOR) , SPEARMINT (NATURAL SPEARMINT FLAVOR) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53499-5272-5 1 in 1 CARTON 01/01/2006 1 120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:53499-5272-9 1 in 1 CARTON 01/01/2006 2 240 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 01/01/2006 Labeler - Schwabe North America, Inc (831153908) Establishment Name Address ID/FEI Business Operations Schwabe North America, Inc 831153908 manufacture(53499-5272)