SPL v1
SPL
SPL Set ID e8917c54-f4c2-3427-e053-2995a90adbf2
Route
ORAL
Published
Effective Date 2022-09-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2022-09-12

Description

Active ingredients (HPUS) Eupatorium perf 12X Kali bichromicum 12X Marrubium vulgare 12X Phosphorus 30X Pulsatilla 12X Rumex crispus 12X Sambucus nigra 12X Cell Salts Calcarea sulphurica 12X Ferrum phosphoricum 12X Kali muriaticum 6X

Purpose

Temporarily Relieves : Thick Mucus Runny Nose & Cough Nasal & Chest Congestion Sinus Inflammation


Medication Information

Purpose

Temporarily Relieves:

  • Thick Mucus
  • Runny Nose & Cough
  • Nasal & Chest Congestion
  • Sinus Inflammation
Description

Active ingredients (HPUS) Eupatorium perf 12X Kali bichromicum 12X Marrubium vulgare 12X Phosphorus 30X Pulsatilla 12X Rumex crispus 12X Sambucus nigra 12X Cell Salts Calcarea sulphurica 12X Ferrum phosphoricum 12X Kali muriaticum 6X

Uses

Uses:

Temporarily relieves

  • cough and congestion associated with colds
  • mucus in chest
  • mucuy cough
  • runny nose
  • sneezing
  • nasal and sinus congestion
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, every 2 hours thereafter.

Children Dose

6 - 18 lbs or 3 - 8 kgs 1.25 mL every 2 hours*

19 - 29 lbs or 9 - 13 kgs 2.5 mL every 2 hours*

30 - 90 lbs or 14 - 41 kgs 5 mL every 2 hours*

*Reduce frequency when symptoms improve.

Pregnacy

Pregnant or breastfeeding

If pregnant or breastfeeding, consult your doctor before use.

Warnings

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 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 condition.
  • 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

Ask A Doctor

Ask a doctor before use if you are taking a prescription drug or have a serious medical conditions.

Please counsult your physcian immidiately for a worsening condition.

Active Ingredient

Active ingredients (HPUS)

Eupatorium perf 12X

Kali bichromicum 12X

Marrubium vulgare 12X

Phosphorus 30X

Pulsatilla 12X

Rumex crispus 12X

Sambucus nigra 12X

Cell Salts

Calcarea sulphurica 12X

Ferrum phosphoricum 12X

Kali muriaticum 6X

Inactive Ingredients

Inactive ingredients

Citric acid, glycerin, grape juice, potassium

sorbate, purified water

Pricipal Display Panel

Label:

Keep Out of Reach of Children

Keep out of reach of children. In case of overdose (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

  • cough and congestion associated with colds
  • mucus in chest
  • mucuy cough
  • runny nose
  • sneezing
  • nasal and sinus congestion
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, every 2 hours thereafter.

Children Dose

6 - 18 lbs or 3 - 8 kgs 1.25 mL every 2 hours*

19 - 29 lbs or 9 - 13 kgs 2.5 mL every 2 hours*

30 - 90 lbs or 14 - 41 kgs 5 mL every 2 hours*

*Reduce frequency when symptoms improve.

Purpose

Temporarily Relieves:

  • Thick Mucus
  • Runny Nose & Cough
  • Nasal & Chest Congestion
  • Sinus Inflammation
Pregnacy (PREGNACY)

Pregnant or breastfeeding

If pregnant or breastfeeding, consult your doctor before use.

Warnings

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 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 condition.
  • 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

Ask A Doctor (ASK A DOCTOR)

Ask a doctor before use if you are taking a prescription drug or have a serious medical conditions.

Please counsult your physcian immidiately for a worsening condition.

Active Ingredient (ACTIVE INGREDIENT)

Active ingredients (HPUS)

Eupatorium perf 12X

Kali bichromicum 12X

Marrubium vulgare 12X

Phosphorus 30X

Pulsatilla 12X

Rumex crispus 12X

Sambucus nigra 12X

Cell Salts

Calcarea sulphurica 12X

Ferrum phosphoricum 12X

Kali muriaticum 6X

Inactive Ingredients (INACTIVE INGREDIENTS)

Inactive ingredients

Citric acid, glycerin, grape juice, potassium

sorbate, purified water

Pricipal Display Panel (PRICIPAL DISPLAY PANEL)

Label:

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

Keep out of reach of children. In case of overdose (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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