SPL v2
SPL
SPL Set ID b79f7319-1ecc-77f5-e053-2a95a90a5a81
Route
ORAL
Published
Effective Date 2020-01-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Eriodictyon Californicum Leaf (8 [hp_X]) Histamine Ipecac Lobelia Inflata Sambucus Nigra Flowering Top Solidago Virgaurea Flowering Top
Inactive Ingredients
Lactose Monohydrate Magnesium Stearate

Identifiers & Packaging

Pill Appearance
Imprint: HLB Shape: round Color: white Size: 9 mm Score: 1
Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2020-01-01

Description

Active Ingredients HPUS: Eriodictyon californicum (Yerba santa)    8 [hp_X] Histaminum                                              8 [hp_X] Ipecacuanha (Ipecac)                                8 [hp_X] Lobelia inflata (Indian tobacco)               8 [hp_X] Sambucus nigra (European elder)            8 [hp_X] Solidago virgaurea (Goldenrod)               8 [hp_X]


Medication Information

Warnings and Precautions

Warnings

Stop use and ask a doctor if symptoms worsen or last for more than 7 days.

If you are pregnant or breastfeeding, ask a health professional before use.

Indications and Usage

Uses

This homeopathic medicine is made from a combination of ingredients traditionally used to help relieve symptoms associated with asthma:

  • gasping for air
  • difficulty breathing
  • wheezing
  • coughing
  • excess mucus
Dosage and Administration

Directions

Chew tablets and let dissolve in mouth.

Do not use more than directed.

Do not take with food.

Repeat 4 times daily and reduce intake with improvement or as directed by a health professional

Age…………………………………………………………........ Dose

Adults and Children 12 years of age and older………...... 2 tablets

Children 2 to 11 years of age…...……………………............ 1 tablet

Children under 2 years of age……………………................. Ask a doctor

Description

Active Ingredients HPUS: Eriodictyon californicum (Yerba santa)    8 [hp_X] Histaminum                                              8 [hp_X] Ipecacuanha (Ipecac)                                8 [hp_X] Lobelia inflata (Indian tobacco)               8 [hp_X] Sambucus nigra (European elder)            8 [hp_X] Solidago virgaurea (Goldenrod)               8 [hp_X]

Section 44425-7

Other information

  • Store at room temperature.
  • Do not use if seal is broken or missing.
Section 50565-1

Keep out of reach of children.

In case of accidental overdose, contact a medical professional or poison control center immediately.

Section 51727-6

Inactive ingredients

Lactose, Magnesium Stearate.

Section 55105-1

Purpose

Homeopathic remedy helps relieve symptoms of asthma:

  • gasping for air
  • difficulty breathing
  • wheezing
  • coughing
  • excess mucus

The letters 'HPUS' indicate that the components in this product are officially monographed in the Homoeopathic Pharmacopoeia of the United States.

*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Section 55106-9

Active Ingredients HPUS:

Eriodictyon californicum (Yerba santa)    8 [hp_X]

Histaminum                                              8 [hp_X]

Ipecacuanha (Ipecac)                                8 [hp_X]

Lobelia inflata (Indian tobacco)               8 [hp_X]

Sambucus nigra (European elder)            8 [hp_X]

Solidago virgaurea (Goldenrod)               8 [hp_X]

Product Label


Structured Label Content

Indications and Usage (34067-9)

Uses

This homeopathic medicine is made from a combination of ingredients traditionally used to help relieve symptoms associated with asthma:

  • gasping for air
  • difficulty breathing
  • wheezing
  • coughing
  • excess mucus
Dosage and Administration (34068-7)

Directions

Chew tablets and let dissolve in mouth.

Do not use more than directed.

Do not take with food.

Repeat 4 times daily and reduce intake with improvement or as directed by a health professional

Age…………………………………………………………........ Dose

Adults and Children 12 years of age and older………...... 2 tablets

Children 2 to 11 years of age…...……………………............ 1 tablet

Children under 2 years of age……………………................. Ask a doctor

Warnings and Precautions (34071-1)

Warnings

Stop use and ask a doctor if symptoms worsen or last for more than 7 days.

If you are pregnant or breastfeeding, ask a health professional before use.

Section 44425-7 (44425-7)

Other information

  • Store at room temperature.
  • Do not use if seal is broken or missing.
Section 50565-1 (50565-1)

Keep out of reach of children.

In case of accidental overdose, contact a medical professional or poison control center immediately.

Section 51727-6 (51727-6)

Inactive ingredients

Lactose, Magnesium Stearate.

Section 55105-1 (55105-1)

Purpose

Homeopathic remedy helps relieve symptoms of asthma:

  • gasping for air
  • difficulty breathing
  • wheezing
  • coughing
  • excess mucus

The letters 'HPUS' indicate that the components in this product are officially monographed in the Homoeopathic Pharmacopoeia of the United States.

*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Section 55106-9 (55106-9)

Active Ingredients HPUS:

Eriodictyon californicum (Yerba santa)    8 [hp_X]

Histaminum                                              8 [hp_X]

Ipecacuanha (Ipecac)                                8 [hp_X]

Lobelia inflata (Indian tobacco)               8 [hp_X]

Sambucus nigra (European elder)            8 [hp_X]

Solidago virgaurea (Goldenrod)               8 [hp_X]

Product Label (Product label)


Advanced Ingredient Data


Raw Label Data

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