Label: SINUS REMEDY- calc carb, euphorbium, hydrastis, kali bic, kali iod, lycopodium, phosphorus, pulsatilla, sanguinaria, thuja occ liquid
- NDC Code(s): 80046-001-02
- Packager: Sunset 20 LLC
- 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.
Drug Label Information
Updated March 9, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
-
ACTIVE INGREDIENT
Active Ingredients / Purpose
Calc carb 9X HPUS .......... head congestion, headache, pressure and aches in eyes
Euphorbium 6X HPUS .......... chest congestion
Hydrastis 6X HPUS .......... rattling or tickling cough, sinus congestion, dry or raw sore throat
Kali bic 9X HPUS .......... watery, itchy, irritating eyes, runny nose, frontal sinus pressue, nasal congestion
Kali iod 8X HPUS .......... pain in frontal sinus
Lycopodium 6X HPUS .......... sore throat
Phosphorus 10X HPUS .......... respiratory congestion
Pulsatilla 4X HPUS .......... pain in forehead, nasal pain, and pressure, sneezing
Sanguinaria 9X HPUS .......... tickling cough, excessive muscus
Thuja occ 6X HPUS .......... dry, hacking cough
"HPUS" indicates that the active ingredients are monographed in the official Homeopathic Pharmacopoeia of the United States.
*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE, NOT FDA EVALUATED.
- INDICATIONS & USAGE
-
WARNINGS
Warnings
As with any drug, ask a doctor before use if pregnant or breast-feeding. Consult a physician if:
- symptoms persist for more than 5 days or worsen.
- symptoms are accompanied by a high fever (over 101° F)
- In case of emergency or accidental overdose, contact a medical professional or Poison Control Center Immediately.
-
DOSAGE & ADMINISTRATION
Directions:
- For best results, do not have anything to eat or drink 10 minutes before or after taking the remedy.
- Shake well before using.
- Measure only with the dropper provided.
- Do not use dropper with other products.
Over 2 years of age 5 drops under tongue 3 times a day for 10-14 days. Under 2 years of age Consult a physician. - OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
SINUS REMEDY
calc carb, euphorbium, hydrastis, kali bic, kali iod, lycopodium, phosphorus, pulsatilla, sanguinaria, thuja occ liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80046-001 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE 9 [hp_X] in 30 mL EUPHORBIA RESINIFERA RESIN (UNII: 1TI1O9028K) (EUPHORBIA RESINIFERA RESIN - UNII:1TI1O9028K) EUPHORBIA RESINIFERA RESIN 6 [hp_X] in 30 mL GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL 6 [hp_X] in 30 mL POTASSIUM DICHROMATE (UNII: T4423S18FM) (DICHROMATE ION - UNII:9LKY4BFN2V) POTASSIUM DICHROMATE 9 [hp_X] in 30 mL POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q) IODIDE ION 8 [hp_X] in 30 mL LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE 6 [hp_X] in 30 mL PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS 10 [hp_X] in 30 mL PULSATILLA VULGARIS WHOLE (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) PULSATILLA VULGARIS WHOLE 4 [hp_X] in 30 mL SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508) (SANGUINARIA CANADENSIS ROOT - UNII:N9288CD508) SANGUINARIA CANADENSIS ROOT 9 [hp_X] in 30 mL THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397) THUJA OCCIDENTALIS LEAFY TWIG 6 [hp_X] in 30 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID ACETATE (UNII: DSO12WL7AU) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80046-001-02 30 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/09/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 03/09/2021 Labeler - Sunset 20 LLC (131425750)
