Sinus Remedy

Sinus Remedy
SPL v1
SPL
SPL Set ID f6c1d93a-b24e-48f7-98d4-a1a64909d77e
Route
ORAL
Published
Effective Date 2021-03-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oyster Shell Calcium Carbonate, Crude (9 [hp_X]) Euphorbia Resinifera Resin (6 [hp_X]) Goldenseal (8 [hp_X]) Dichromate Ion (10 [hp_X]) Iodide Ion (4 [hp_X]) Lycopodium Clavatum Spore Phosphorus Anemone Pulsatilla Sanguinaria Canadensis Root Thuja Occidentalis Leafy Twig
Inactive Ingredients
Citric Acid Acetate Potassium Sorbate Water Glycerin

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2021-03-09

Description

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.


Medication Information

Warnings and Precautions

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.
Indications and Usage

Uses*

  • Temporarily relieves the following common sinus symptoms that have lasted at least seven (7) days:
  • nasal congestion  •sinus pain & pressure •mucus discharge •cough •sore throat •eye irritation •headache
Dosage and 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.

Description

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.

Section 50565-1
  • Keep this and all medications out of reach of children.
Section 51727-6

Inactive ingredients

Citric Acid, Potassium Sorbate, Purified Water, Vegetable Glycerin.

Section 53413-1

Manufactured for:

Sunset 20 LLC

Miami Beach, FL 33139

[email protected]

(305) 672-7337

Section 55105-1

NDC: 80046-001-02

Dr.

Eisenberg's

Homeopathics™

SINUS REMEDY

Relieves Prolonged Sinus

Congestion, Cough and Pain

1 FL OZ (30mL)

Rev.001

Section 55106-9

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.

Section 60561-8

Other information

  • Do not use if tamper-evident bottle neck band is broken or missing.
  • Store at room temperature.
  • Do not refrigerate.
  • Keep away from cell phones or microwaves

Structured Label Content

Indications and Usage (34067-9)

Uses*

  • Temporarily relieves the following common sinus symptoms that have lasted at least seven (7) days:
  • nasal congestion  •sinus pain & pressure •mucus discharge •cough •sore throat •eye irritation •headache
Dosage and Administration (34068-7)

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.

Warnings and Precautions (34071-1)

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.
Section 50565-1 (50565-1)
  • Keep this and all medications out of reach of children.
Section 51727-6 (51727-6)

Inactive ingredients

Citric Acid, Potassium Sorbate, Purified Water, Vegetable Glycerin.

Section 53413-1 (53413-1)

Manufactured for:

Sunset 20 LLC

Miami Beach, FL 33139

[email protected]

(305) 672-7337

Section 55105-1 (55105-1)

NDC: 80046-001-02

Dr.

Eisenberg's

Homeopathics™

SINUS REMEDY

Relieves Prolonged Sinus

Congestion, Cough and Pain

1 FL OZ (30mL)

Rev.001

Section 55106-9 (55106-9)

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.

Section 60561-8 (60561-8)

Other information

  • Do not use if tamper-evident bottle neck band is broken or missing.
  • Store at room temperature.
  • Do not refrigerate.
  • Keep away from cell phones or microwaves

Advanced Ingredient Data


Raw Label Data

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