SPL v3
SPL
SPL Set ID 91c311b2-a22c-0db0-e053-2995a90af3ef
Route
ORAL
Published
Effective Date 2020-07-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Eupatorium Perfoliatum Flowering Top (12 [hp_X]) Sambucus Nigra Flowering Top (6 [hp_X]) Calcium Cation (30 [hp_X]) Potassium Cation Marrubium Vulgare Phosphorus Rumex Crispus Root Ferrosoferric Phosphate Calcium Sulfide Dichromate Ion Anemone Pulsatilla
Inactive Ingredients
Concord Grape Juice Potassium Sorbate Water Glycerin Citric Acid Monohydrate

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2020-07-20

Description

Active Ingredients Eupatorium perf 12X HPUS Hepar sulphuris calcareum 12X HPUS Kali bichromicum 12X HPUS Marrubium vulgare 12X HPUS Phosphorus 30X HPUS Pulsatilla 12X HPUS Rumex crispus 12X HPUS Sambucus nigra 12x HPUS Cell Salts Calcarea sulphurica 12X HPUS Ferrum phosphoricum 12X HPUS Kali muriaticum 6X HPUS

Purpose

Purpose Congestion, soreness Yellowish mucus discharge Sinus congestion Cough with expectoration Chest congestion Discharge of thick yellowish mucus Copious mucus discharge Nasal congestion Thick mucus yellowish discharges Congestion and inflammation of mucus membranes Inflammation with discharge


Medication Information

Purpose

Purpose

Congestion, soreness

Yellowish mucus discharge

Sinus congestion

Cough with expectoration

Chest congestion

Discharge of thick yellowish mucus

Copious mucus discharge

Nasal congestion

Thick mucus yellowish discharges

Congestion and inflammation of mucus membranes

Inflammation with discharge

Description

Active Ingredients Eupatorium perf 12X HPUS Hepar sulphuris calcareum 12X HPUS Kali bichromicum 12X HPUS Marrubium vulgare 12X HPUS Phosphorus 30X HPUS Pulsatilla 12X HPUS Rumex crispus 12X HPUS Sambucus nigra 12x HPUS Cell Salts Calcarea sulphurica 12X HPUS Ferrum phosphoricum 12X HPUS Kali muriaticum 6X HPUS

Uses

Uses

Temporarily relieves

  • mucusy cough
  • cough and congestion associated with colds
  • nasal and sinus congestion
  • mucus in chest
  • sneezing
  • runny nose

Warnings

Do not use:

  • for persistent or chronic cough
  • for treating cough from asthma, smoking, or emphysema
  • for treating cough with excessive mucus

A persistent cough may be a sign of a serious condition

Stop use and ask doctor if:

  • cough/congestion lasts for more than 7 days.
  • cough/congestion comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious confition.
  • 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

Active Ingredients

Active Ingredients

Eupatorium perf 12X HPUS

Hepar sulphuris calcareum 12X HPUS

Kali bichromicum 12X HPUS

Marrubium vulgare 12X HPUS

Phosphorus 30X HPUS

Pulsatilla 12X HPUS

Rumex crispus 12X HPUS

Sambucus nigra 12x HPUS

Cell Salts

Calcarea sulphurica 12X HPUS

Ferrum phosphoricum 12X HPUS

Kali muriaticum 6X HPUS

Inactive Ingredients

Inactive Ingredients

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

Principal Display Panel

Pregnancy 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

Uses

Uses

Temporarily relieves

  • mucusy cough
  • cough and congestion associated with colds
  • nasal and sinus congestion
  • mucus in chest
  • sneezing
  • runny nose

Purpose

Purpose

Congestion, soreness

Yellowish mucus discharge

Sinus congestion

Cough with expectoration

Chest congestion

Discharge of thick yellowish mucus

Copious mucus discharge

Nasal congestion

Thick mucus yellowish discharges

Congestion and inflammation of mucus membranes

Inflammation with discharge

Warnings

Do not use:

  • for persistent or chronic cough
  • for treating cough from asthma, smoking, or emphysema
  • for treating cough with excessive mucus

A persistent cough may be a sign of a serious condition

Stop use and ask doctor if:

  • cough/congestion lasts for more than 7 days.
  • cough/congestion comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious confition.
  • 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

Active Ingredients

Active Ingredients

Eupatorium perf 12X HPUS

Hepar sulphuris calcareum 12X HPUS

Kali bichromicum 12X HPUS

Marrubium vulgare 12X HPUS

Phosphorus 30X HPUS

Pulsatilla 12X HPUS

Rumex crispus 12X HPUS

Sambucus nigra 12x HPUS

Cell Salts

Calcarea sulphurica 12X HPUS

Ferrum phosphoricum 12X HPUS

Kali muriaticum 6X HPUS

Inactive Ingredients

Inactive Ingredients

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

Principal Display Panel

Pregnancy Or Breastfeeding (Pregnancy 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

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