SPL v3
SPL
SPL Set ID 91d50391-f6a7-febf-e053-2995a90a1b02
Route
ORAL
Published
Effective Date 2020-07-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Matricaria Recutita (12 [hp_X]) Eupatorium Perfoliatum Flowering Top (6 [hp_X]) Calendula Officinalis Flowering Top Echinacea Angustifolia Calcium Sulfide Potassium Cation Ferrosoferric Phosphate Cosmos Sulphureus Flowering Top
Inactive Ingredients
Citric Acid Monohydrate Glycerin Concord Grape Juice Water Potassium Sorbate

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2020-07-20

Description

Active Ingredients Calendula officinalis 12X HPUS Chamomilla 12X HPUS Echinacea angustifolia 12X HPUS Eupatorium perfoliatum 12X HPUS Hepar sulphuris calcareum 12X HPUS Sulphur 12X HPUS Cell Salts Ferrum phosphoricum 12X HPUS Kali muriaticum 6X HPUS

Purpose

Purpose Reduces inflammation Hypersensitivity, irritability Weakness, aching body Aching pain, flu-like symptoms Hypersensitive to cold, chills Headache, symptoms of fever Symptoms of fever Glandular swellings, inflammation


Medication Information

Purpose

Purpose

Reduces inflammation

Hypersensitivity, irritability

Weakness, aching body

Aching pain, flu-like symptoms

Hypersensitive to cold, chills

Headache, symptoms of fever

Symptoms of fever

Glandular swellings, inflammation

Description

Active Ingredients Calendula officinalis 12X HPUS Chamomilla 12X HPUS Echinacea angustifolia 12X HPUS Eupatorium perfoliatum 12X HPUS Hepar sulphuris calcareum 12X HPUS Sulphur 12X HPUS Cell Salts Ferrum phosphoricum 12X HPUS Kali muriaticum 6X HPUS

Warnings

Stop use and ask doctor if:

  • fever wosens or lasts more than 2 days
  • pain gets worse or lasts more than 7 days
  • other symptoms persist for more than 7 days or worsen
  • Ask a doctor before use if you are taking a prescription drug or have a serious medical condition.
  • Please consult your physician immediately for a worsening condition.

Questions

Questions or Comments?

Call us at 1-800-588-6227

M-F 8am-5pm CST

Directions
  • Shake before use, natural juice may settle
  • Measure only with the dosing syringe provided
  • Do not use dosing syringe with other products
  • On dosing syringe, weight is specific to product
  • On dosing syringe, ml = milliliter, lbs = pounds, kgs = kilograms

Children under 6 months of age, consult a medical professional before using this product.

For sudden onset of symptoms: Use every 15 minutes for up to 8 doses until symptoms relieved, then every 2 hours thereafter.

Children 6 - 18 lbs or 3 - 8 kgs

1.25 ml every 2 hours, reduce frequency when symptoms improve

Children 19 - 29 lbs or 9 - 13 kgs

2.5 ml every 2 hours, reduce frequency when symptoms improve

Children 30 - 90 lbs or 14 - 41 kgs

5 ml every 2 hours, reduce frequency when symptoms improve

Acitve Ingredients

Active Ingredients

Calendula officinalis 12X HPUS

Chamomilla 12X HPUS

Echinacea angustifolia 12X HPUS

Eupatorium perfoliatum 12X HPUS

Hepar sulphuris calcareum 12X HPUS

Sulphur 12X HPUS

Cell Salts

Ferrum phosphoricum 12X HPUS

Kali muriaticum 6X HPUS

Inactive Ingredients

Inactive ingredients

Citric acid, glycerin, grape juice, potassium sorbate, purified water

Principal Display Panel

Pregnant Or Breastfeeding

If pregnant or breastfeeding, consult your doctor before use.

Keep Out of Reach of Children

Keep out of reach of children. In case of overdoes (or accidental ingestion), get medical help or contact a Poison Control Center right away. DO NOT USE IF SEAL UNDER CAP IS BROKEN OR MISSING.


Structured Label Content

Purpose

Purpose

Reduces inflammation

Hypersensitivity, irritability

Weakness, aching body

Aching pain, flu-like symptoms

Hypersensitive to cold, chills

Headache, symptoms of fever

Symptoms of fever

Glandular swellings, inflammation

Warnings

Stop use and ask doctor if:

  • fever wosens or lasts more than 2 days
  • pain gets worse or lasts more than 7 days
  • other symptoms persist for more than 7 days or worsen
  • Ask a doctor before use if you are taking a prescription drug or have a serious medical condition.
  • Please consult your physician immediately for a worsening condition.

Questions

Questions or Comments?

Call us at 1-800-588-6227

M-F 8am-5pm CST

Directions
  • Shake before use, natural juice may settle
  • Measure only with the dosing syringe provided
  • Do not use dosing syringe with other products
  • On dosing syringe, weight is specific to product
  • On dosing syringe, ml = milliliter, lbs = pounds, kgs = kilograms

Children under 6 months of age, consult a medical professional before using this product.

For sudden onset of symptoms: Use every 15 minutes for up to 8 doses until symptoms relieved, then every 2 hours thereafter.

Children 6 - 18 lbs or 3 - 8 kgs

1.25 ml every 2 hours, reduce frequency when symptoms improve

Children 19 - 29 lbs or 9 - 13 kgs

2.5 ml every 2 hours, reduce frequency when symptoms improve

Children 30 - 90 lbs or 14 - 41 kgs

5 ml every 2 hours, reduce frequency when symptoms improve

Acitve Ingredients

Active Ingredients

Calendula officinalis 12X HPUS

Chamomilla 12X HPUS

Echinacea angustifolia 12X HPUS

Eupatorium perfoliatum 12X HPUS

Hepar sulphuris calcareum 12X HPUS

Sulphur 12X HPUS

Cell Salts

Ferrum phosphoricum 12X HPUS

Kali muriaticum 6X HPUS

Inactive Ingredients

Inactive ingredients

Citric acid, glycerin, grape juice, potassium sorbate, purified water

Principal Display Panel

Pregnant Or Breastfeeding (Pregnant or breastfeeding)

If pregnant or breastfeeding, consult your doctor before use.

Keep Out of Reach of Children (Keep out of reach of children)

Keep out of reach of children. In case of overdoes (or accidental ingestion), get medical help or contact a Poison Control Center right away. DO NOT USE IF SEAL UNDER CAP IS BROKEN OR MISSING.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)