SPL v1
SPL
SPL Set ID e892c0cb-03b4-52da-e053-2995a90a0878
Route
ORAL
Published
Effective Date 2022-09-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2022-09-12

Description

Active ingredients (HPUS) Arnica 12X Bellis perennis 12X Calendula officinalis 12X Chamomilla 12X Coffea cruda 12X Hypericum 12X Millefolium 12X Cell Salts Ferrum phosphoricum 12X Kali muriaticum 6X Magnesia phosphorica 6X

Purpose

Temporarily Relieves: Toothache Nerve Pain from Trauma Growing, Joint, & Muscular Pain Bruising & SWelling


Medication Information

Purpose

Temporarily Relieves:

  • Toothache
  • Nerve Pain from Trauma
  • Growing, Joint, & Muscular Pain
  • Bruising & SWelling
Description

Active ingredients (HPUS) Arnica 12X Bellis perennis 12X Calendula officinalis 12X Chamomilla 12X Coffea cruda 12X Hypericum 12X Millefolium 12X Cell Salts Ferrum phosphoricum 12X Kali muriaticum 6X Magnesia phosphorica 6X

Usage

Uses:

Temporarily relieves minor aches and pains due to:

  • toothache
  • muscle pain and swelling
  • bruises
  • nerve pain
  • vascular pain
  • joint and bone pain
  • inflamation and swelling from trauma
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 upto 8 doses until symtoms 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.

Warning

Warnings:

Stop use and ask a doctor if:

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

Pregnant or breastfeeding

If pregnant or breastfeeding, consult your doctor before use.

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 condition.

Please consult your physician immediately for a worsening condition.

Active Ingredients

Active ingredients (HPUS)

Arnica 12X

Bellis perennis 12X

Calendula officinalis 12X

Chamomilla 12X

Coffea cruda 12X

Hypericum 12X

Millefolium 12X

Cell Salts

Ferrum phosphoricum 12X

Kali muriaticum 6X

Magnesia phosphorica 6X

Inactive Ingredients

Inactive ingredients

Citric acid, glycerin, grape juice, potassium

sorbate, purified water

Principal Display Panel

Principal Display Panel

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

Usage

Uses:

Temporarily relieves minor aches and pains due to:

  • toothache
  • muscle pain and swelling
  • bruises
  • nerve pain
  • vascular pain
  • joint and bone pain
  • inflamation and swelling from trauma
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 upto 8 doses until symtoms 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:

  • Toothache
  • Nerve Pain from Trauma
  • Growing, Joint, & Muscular Pain
  • Bruising & SWelling
Warning

Warnings:

Stop use and ask a doctor if:

  • fever develops, worsens, or lasts more than 3 days
  • pain gets worse or lasts more than 7 days
  • other symtoms persist for more than 7 days or worsen
Pregnancy (PREGNANCY)

Pregnant or breastfeeding

If pregnant or breastfeeding, consult your doctor before use.

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 condition.

Please consult your physician immediately for a worsening condition.

Active Ingredients (ACTIVE INGREDIENTS)

Active ingredients (HPUS)

Arnica 12X

Bellis perennis 12X

Calendula officinalis 12X

Chamomilla 12X

Coffea cruda 12X

Hypericum 12X

Millefolium 12X

Cell Salts

Ferrum phosphoricum 12X

Kali muriaticum 6X

Magnesia phosphorica 6X

Inactive Ingredients (INACTIVE INGREDIENTS)

Inactive ingredients

Citric acid, glycerin, grape juice, potassium

sorbate, purified water

Principal Display Panel

Principal Display Panel

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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