SPL v3
SPL
SPL Set ID 91d57aae-7c68-cc4a-e053-2995a90aad9d
Route
ORAL
Published
Effective Date 2020-07-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Arabica Coffee Bean (12 [hp_X]) Magnesium Phosphate, Dibasic (6 [hp_X]) Achillea Millefolium Arnica Montana Ferrosoferric Phosphate Hypericum Perforatum Bellis Perennis Calendula Officinalis Flowering Top Matricaria Recutita Potassium Cation
Inactive Ingredients
Citric Acid Monohydrate Glycerin Concord Grape Juice Potassium Sorbate Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2020-07-20

Description

Active Ingredients Arnica 12X HPUS Bellis perennis 12X HPUS Calendula Officinalis 12X HPUS Chamomilla 12X HPUS Coffea cruda 12X HPUS Hypericum 12X HPUS Millefolium 12X HPUS Cell Salts Ferrum phosphoricum 12X HPUS Kali muriaticum 6X HPUS Magnesia phosphorica 6XHPUS

Purpose

Purpose Trauma, bruises Injuries to muscles Reduces inflammation Hypersensitivity Sensitiveness to pain Injuries to nerves, nerve pain Vascular injuries Inflammation due to trauma Swelling Spasmodic pains


Medication Information

Purpose

Purpose

Trauma, bruises

Injuries to muscles

Reduces inflammation

Hypersensitivity

Sensitiveness to pain

Injuries to nerves, nerve pain

Vascular injuries

Inflammation due to trauma

Swelling

Spasmodic pains

Description

Active Ingredients Arnica 12X HPUS Bellis perennis 12X HPUS Calendula Officinalis 12X HPUS Chamomilla 12X HPUS Coffea cruda 12X HPUS Hypericum 12X HPUS Millefolium 12X HPUS Cell Salts Ferrum phosphoricum 12X HPUS Kali muriaticum 6X HPUS Magnesia phosphorica 6XHPUS

Uses

Uses

Temporarily relieves minor aches and pains due to:

  • bruises
  • toothache
  • nerve pain
  • vascular pain
  • nerve pain
  • inflammation and swelling from trauma
  • muscle pain and swelling
  • joint and bone pain

Warnings

Stop use and ask doctor if:

  • fever develops, worsens, or lasts more than 3 days
  • pain gets worse or lasts more than 7 days
  • other symptoms persist for more than 7 days or worsen
  • 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

Arnica 12X HPUS

Bellis perennis 12X HPUS

Calendula Officinalis 12X HPUS

Chamomilla 12X HPUS

Coffea cruda 12X HPUS

Hypericum 12X HPUS

Millefolium 12X HPUS

Cell Salts

Ferrum phosphoricum 12X HPUS

Kali muriaticum 6X HPUS

Magnesia phosphorica 6XHPUS

Inactive Ingredients

Inactive ingredients

Citric acid, 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 minor aches and pains due to:

  • bruises
  • toothache
  • nerve pain
  • vascular pain
  • nerve pain
  • inflammation and swelling from trauma
  • muscle pain and swelling
  • joint and bone pain

Purpose

Purpose

Trauma, bruises

Injuries to muscles

Reduces inflammation

Hypersensitivity

Sensitiveness to pain

Injuries to nerves, nerve pain

Vascular injuries

Inflammation due to trauma

Swelling

Spasmodic pains

Warnings

Stop use and ask doctor if:

  • fever develops, worsens, or lasts more than 3 days
  • pain gets worse or lasts more than 7 days
  • other symptoms persist for more than 7 days or worsen
  • 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

Arnica 12X HPUS

Bellis perennis 12X HPUS

Calendula Officinalis 12X HPUS

Chamomilla 12X HPUS

Coffea cruda 12X HPUS

Hypericum 12X HPUS

Millefolium 12X HPUS

Cell Salts

Ferrum phosphoricum 12X HPUS

Kali muriaticum 6X HPUS

Magnesia phosphorica 6XHPUS

Inactive Ingredients

Inactive ingredients

Citric acid, 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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