SPL v1
SPL
SPL Set ID e8902c05-3303-2e0f-e053-2a95a90aa15d
Route
ORAL
Published
Effective Date 2022-09-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2022-09-12

Description

Active ingredients (HPUS) Antimonium tartaricum 12X Drosera rotundifolia 12X Ipecacuanha 12X Phosphorus 12X Rumex crispus 12X Spongia tosta 12X Sticta pulmonaria 12X Cell Salts Kali sulphuricum 6X

Purpose

Temporarily Relieves: Dry Cough Sore Throat from cough Mucus Buildup & Cough Chest Congestion


Medication Information

Purpose

Temporarily Relieves:

  • Dry Cough
  • Sore Throat from cough
  • Mucus Buildup & Cough
  • Chest Congestion
Description

Active ingredients (HPUS) Antimonium tartaricum 12X Drosera rotundifolia 12X Ipecacuanha 12X Phosphorus 12X Rumex crispus 12X Spongia tosta 12X Sticta pulmonaria 12X Cell Salts Kali sulphuricum 6X

Usage

Uses

Temporarily relieves

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

Children under 6 months of age, consult a medical professional before using this product.(SEE ATTCHED PRODUCT IMAGE)

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

Question

Questions

Questions or Comments?(SEE ATTCHED PRODUCT LABEL IMAGE)

Warnings

Warnings

Do not use:

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

A persistent cough may be a sign of a serious condition

Pregnancy

Pregnant or breastfeeding

If pregnant or breastfeeding, consult your doctor before use.(SEE ATTCHED PRODUCT LABEL IMAGE)

Ask A Doctor

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 .

Instructions

For sudden onset of symptoms: (SEE ATTCHED PRODUCT LABEL IMAGE)

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

Principal Display

Principal Display Panel

Active Ingredients

Active ingredients (HPUS)



Antimonium tartaricum 12X

Drosera rotundifolia 12X

Ipecacuanha 12X

Phosphorus 12X

Rumex crispus 12X

Spongia tosta 12X

Sticta pulmonaria 12X

Cell Salts

Kali sulphuricum 6X

Inactive Ingredients

Inactive ingredients (SEE PRODUCT LABEL IMAGE)

Citric acid, elderberry juice, glycerin, grape

juice, potassium sorbate, purified water

Keep Out of Reach of Children Section

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.(SEE ATTCHED PRODUCT LABEL IMAGE)


Structured Label Content

Usage

Uses

Temporarily relieves

  • sore throat
  • chest congestion
  • dry, ticking, mucusy, and/or spasmodic coughs associated with colds
Dosage (DOSAGE)

Children under 6 months of age, consult a medical professional before using this product.(SEE ATTCHED PRODUCT IMAGE)

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:

  • Dry Cough
  • Sore Throat from cough
  • Mucus Buildup & Cough
  • Chest Congestion
Question (QUESTION)

Questions

Questions or Comments?(SEE ATTCHED PRODUCT LABEL IMAGE)

Warnings

Warnings

Do not use:

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

A persistent cough may be a sign of a serious condition

Pregnancy (PREGNANCY)

Pregnant or breastfeeding

If pregnant or breastfeeding, consult your doctor before use.(SEE ATTCHED PRODUCT LABEL IMAGE)

Ask A Doctor (ASK A DOCTOR)

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 .

Instructions (INSTRUCTIONS)

For sudden onset of symptoms: (SEE ATTCHED PRODUCT LABEL IMAGE)

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

Principal Display (PRINCIPAL DISPLAY)

Principal Display Panel

Active Ingredients (ACTIVE INGREDIENTS)

Active ingredients (HPUS)



Antimonium tartaricum 12X

Drosera rotundifolia 12X

Ipecacuanha 12X

Phosphorus 12X

Rumex crispus 12X

Spongia tosta 12X

Sticta pulmonaria 12X

Cell Salts

Kali sulphuricum 6X

Inactive Ingredients (INACTIVE INGREDIENTS)

Inactive ingredients (SEE PRODUCT LABEL IMAGE)

Citric acid, elderberry juice, glycerin, grape

juice, potassium sorbate, purified water

Keep Out of Reach of Children Section (KEEP OUT OF REACH OF CHILDREN SECTION)

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.(SEE ATTCHED PRODUCT LABEL IMAGE)


Advanced Ingredient Data


Raw Label Data

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