Label: UMCKA COUGH ACONITUM NAPELLUS, BRYONIA ALBA ROOT, CALCIUM SULFIDE, SPONGIA OFFICINALIS SKELETON, ROASTED , TIN, PELARGONIUM SIDOIDES ROOT- umcka cough syrup
- NDC Code(s): 53499-5864-4
- Packager: Schwabe North America, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
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.
Updated April 24, 2020
If you are a consumer or patient please visit this version.
- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- INDICATIONS & USAGE
DOSAGE & ADMINISTRATION
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 and Children 12 years of age and older: take 1 1/2 teaspoons (tsp) (7.5 mL) three times daily.
Children 6 to 11 years of age: take 1 teaspoon (5 mL) three times daily.
Children under 6 years of age: Consult a physician.
Sore throat warning: severe or persistent sore throat for more than 2 days or if accompanied by high fever, headache, nausea, vomiting or rash may be serious.
Consult a physician promptly.
Ask a doctor before use if you have: persistent or chronic cough that lasts, is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema, or is accompanied by excessive phlegm (mucus).
Stop use and ask a doctor if: new symptoms occur, symptoms get worse or last more than 7 days, fever worsens or lasts more than 3 days, cough lasts more than 7 days or occurs with rash or persistent headache.
These could be a sign of a serious condition.
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
UMCKA COUGH ACONITUM NAPELLUS, BRYONIA ALBA ROOT, CALCIUM SULFIDE, SPONGIA OFFICINALIS SKELETON, ROASTED , TIN, PELARGONIUM SIDOIDES ROOT
umcka cough syrup
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53499-5864 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 ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS 3 [hp_X] in 120 mL BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT 3 [hp_X] in 120 mL CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE 6 [hp_C] in 120 mL TIN (UNII: 387GMG9FH5) (TIN - UNII:387GMG9FH5) TIN 6 [hp_C] in 120 mL SPONGIA OFFICINALIS SKELETON, ROASTED (UNII: 1PIP394IID) (SPONGIA OFFICINALIS SKELETON, ROASTED - UNII:1PIP394IID) SPONGIA OFFICINALIS SKELETON, ROASTED 3 [hp_X] in 120 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) HEDERA HELIX LEAF (UNII: ZP9XFG71A7) ALCOHOL (UNII: 3K9958V90M) GLYCERIN (UNII: PDC6A3C0OX) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MALTODEXTRIN (UNII: 7CVR7L4A2D) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53499-5864-4 1 in 1 BOX 10/01/2012 1 120 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 10/01/2012 Labeler - Schwabe North America, Inc. (831153908) Establishment Name Address ID/FEI Business Operations Schwabe North America 831153908 manufacture(53499-5864)