SPL v3
SPL
SPL Set ID 91d3e4d6-356b-4e7f-e053-2a95a90a5158
Route
ORAL
Published
Effective Date 2020-07-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pulmonaria Officinalis Whole (12 [hp_X]) Antimony Tartrate Ion (6 [hp_X]) Drosera Rotundifolia Flowering Top Phosphorus Rumex Crispus Root Potassium Cation Spongia Officinalis Skeleton, Roasted Ipecac
Inactive Ingredients
European Elderberry Juice Glycerin Potassium Sorbate Water Concord Grape Juice Citric Acid Monohydrate

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2020-07-20

Description

Active Ingredients Antimonium tartaricum 12X HPUS Drosera rotundifolia 12X HPUS Ipecacuanha 12X HPUS Phosphorus 12X HPUS Rumex crispus 12X HPUS Spongia Tosta 12X HPUS Sticta pulmonaria 12X HPUS Cell Salts Kali sulphuricum 6X HPUS

Purpose

Purpose Thick mucus Spasmodic cough Gagging cough Oppresive cough Barking cough Dry cough Hacking cough Rattling of mucus in chest


Medication Information

Purpose

Purpose

Thick mucus

Spasmodic cough

Gagging cough

Oppresive cough

Barking cough

Dry cough

Hacking cough

Rattling of mucus in chest

Description

Active Ingredients Antimonium tartaricum 12X HPUS Drosera rotundifolia 12X HPUS Ipecacuanha 12X HPUS Phosphorus 12X HPUS Rumex crispus 12X HPUS Spongia Tosta 12X HPUS Sticta pulmonaria 12X HPUS Cell Salts Kali sulphuricum 6X HPUS

Uses

Uses

Temporarily relieves

  • sore throat
  • dry, tickling, mucusy, and/or spasmodic coughs associated with colds
  • chest congestion

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

Antimonium tartaricum 12X HPUS

Drosera rotundifolia 12X HPUS

Ipecacuanha 12X HPUS

Phosphorus 12X HPUS

Rumex crispus 12X HPUS

Spongia Tosta 12X HPUS

Sticta pulmonaria 12X HPUS

Cell Salts

Kali sulphuricum 6X HPUS

Inactive Ingredients

Inactive ingredients

Citric acid, elderberry juice, 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

  • sore throat
  • dry, tickling, mucusy, and/or spasmodic coughs associated with colds
  • chest congestion

Purpose

Purpose

Thick mucus

Spasmodic cough

Gagging cough

Oppresive cough

Barking cough

Dry cough

Hacking cough

Rattling of mucus in chest

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

Antimonium tartaricum 12X HPUS

Drosera rotundifolia 12X HPUS

Ipecacuanha 12X HPUS

Phosphorus 12X HPUS

Rumex crispus 12X HPUS

Spongia Tosta 12X HPUS

Sticta pulmonaria 12X HPUS

Cell Salts

Kali sulphuricum 6X HPUS

Inactive Ingredients

Inactive ingredients

Citric acid, elderberry juice, 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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