SPL v2
SPL
SPL Set ID e881a3ce-8cf9-0ce6-e053-2995a90ae824
Route
ORAL
Published
Effective Date 2022-09-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2022-09-12

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

Temporarily Relieves: Fever headache Achy & Sore Pain Flu-like Symptoms


Medication Information

Purpose

Temporarily Relieves:

  • Fever
  • headache
  • Achy & Sore Pain
  • Flu-like Symptoms
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

Usage

Uses: Temproraily relieves

  • general sorness
  • fever
  • irritability
  • body ache
  • flu
  • cold chills
  • swollen glands
Dosage

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

Warnings

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
Questions

Questions or comments?

Call us at 1-855-366-7755 (U.S.A. only)

M-F 8am-5pm CST

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

LABEL DISPLAY:

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.


Structured Label Content

Usage

Uses: Temproraily relieves

  • general sorness
  • fever
  • irritability
  • body ache
  • flu
  • cold chills
  • swollen glands
Dosage (DOSAGE)

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

Purpose

Temporarily Relieves:

  • Fever
  • headache
  • Achy & Sore Pain
  • Flu-like Symptoms
Warnings (WARNINGS)

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
Questions (QUESTIONS)

Questions or comments?

Call us at 1-855-366-7755 (U.S.A. only)

M-F 8am-5pm CST

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)

Inactive ingredients

Citric acid, glycerin, grape juice, potassium

sorbate, purified water.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

LABEL DISPLAY:

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

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)