SPL v2
SPL
SPL Set ID b79dbfd3-0048-06d8-e053-2a95a90adfbc
Route
ORAL
Published
Effective Date 2020-01-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Onion (8 [hp_X]) Aralia Racemosa Root Arsenic Cation (3+) Copper Euphrasia Stricta Strychnos Nux-vomica Seed Schoenocaulon Officinale Seed Lobaria Pulmonaria
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: Allium cepa (Onion)                              8 [hp-X] Aralia racemosa (Spikenard)                  8 [hp-X] Arsenicum album (Arsenous trioxyde)   8 [hp-X] Cuprum metallicum (Metallic copper)   8 [hp-X] Euphrasia officinalis (Eyebright)           8 [hp-X] Nux vomica (Poison nut)                        8 [hp-X] Sabadilla (Sabadilla)                              8 [hp-X] Sticta pulmonaria (Lungwort)               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 remedy to relieve from symptoms of all allergies

  • Nasal congestion
  • Sneezing
  • Runny nose
  • Itchy, watery eyes
Dosage and Administration

Directions

Chew tablets and let dissolve in mouth.

Do not use more than directed.

Do not take with food.

Repeat 3 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: Allium cepa (Onion)                              8 [hp-X] Aralia racemosa (Spikenard)                  8 [hp-X] Arsenicum album (Arsenous trioxyde)   8 [hp-X] Cuprum metallicum (Metallic copper)   8 [hp-X] Euphrasia officinalis (Eyebright)           8 [hp-X] Nux vomica (Poison nut)                        8 [hp-X] Sabadilla (Sabadilla)                              8 [hp-X] Sticta pulmonaria (Lungwort)               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 all types of allergies:

  • itchy, watery eyes
  • red burning eyes and sneezing
  • nasal congestion, coryza
  • burning and swelling of the eye lids
  • sneezing, runny nose, hay fever
  • hay fever, sneezing, runny nose
  • dry cough, hay fever
  • itchy eyes, nasal congestion

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:

Allium cepa (Onion)                              8 [hp-X]

Aralia racemosa (Spikenard)                  8 [hp-X]

Arsenicum album (Arsenous trioxyde)   8 [hp-X]

Cuprum metallicum (Metallic copper)   8 [hp-X]

Euphrasia officinalis (Eyebright)           8 [hp-X]

Nux vomica (Poison nut)                        8 [hp-X]

Sabadilla (Sabadilla)                              8 [hp-X]

Sticta pulmonaria (Lungwort)               8 [hp-X]

Product Label


Structured Label Content

Indications and Usage (34067-9)

Uses

This homeopathic remedy to relieve from symptoms of all allergies

  • Nasal congestion
  • Sneezing
  • Runny nose
  • Itchy, watery eyes
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 3 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 all types of allergies:

  • itchy, watery eyes
  • red burning eyes and sneezing
  • nasal congestion, coryza
  • burning and swelling of the eye lids
  • sneezing, runny nose, hay fever
  • hay fever, sneezing, runny nose
  • dry cough, hay fever
  • itchy eyes, nasal congestion

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:

Allium cepa (Onion)                              8 [hp-X]

Aralia racemosa (Spikenard)                  8 [hp-X]

Arsenicum album (Arsenous trioxyde)   8 [hp-X]

Cuprum metallicum (Metallic copper)   8 [hp-X]

Euphrasia officinalis (Eyebright)           8 [hp-X]

Nux vomica (Poison nut)                        8 [hp-X]

Sabadilla (Sabadilla)                              8 [hp-X]

Sticta pulmonaria (Lungwort)               8 [hp-X]

Product Label (Product label)


Advanced Ingredient Data


Raw Label Data

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