SPL v2
SPL
SPL Set ID be9661a8-d3fb-47be-ac09-d4e82cc63161
Route
ORAL
Published
Effective Date 2018-03-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Arnica Montana (8 [hp_X]) Ferrosoferric Phosphate Hypericum Perforatum Thuja Occidentalis Leafy Twig Ledum Palustre Twig
Inactive Ingredients
Water Sorbitol Sodium Benzoate Potassium Sorbate Citric Acid Acetate

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2017-03-03

Description

Active Ingredients HPUS: Arnica montana 8X    (Leopard's bane) Ferrum phosphoricum 8X    (Ferrosoferric phosphate) Hypericum perforatum 8X    (St. John's wort) Thuja occidentalis 8X    (White cedar) Ledum palustre 8X (Wild rosemary) The letters 'HPUS' indicate that the component in this product is officially monographed in the Homeopathic Pharmacopoeia of the United States.


Medication Information

Warnings and Precautions

Warnings

Stop use and ask a doctor in cases of high fever or if

symptoms worsen or persist for mroe than 2 days.

Indications and Usage

Uses

This homeopathic medicine is made from a combination of

ingredients traditionally used to help temporarily reduce

fever and relieve minor aches and pains associated with:

   •common cold                  •headache

   •sore throat                     •toothache

Dosage and Administration

Directions

Children under 6 months of age: Consult a licensed healthcare

practitioner before using this product

Children under 6 months to 2 years old: 0.5 ml orally every 8 hours

or 3 times a day

Children 2 to 12 years old: 0.75 ml orally every 8 hours or

3 times a day

Description

Active Ingredients HPUS: Arnica montana 8X    (Leopard's bane) Ferrum phosphoricum 8X    (Ferrosoferric phosphate) Hypericum perforatum 8X    (St. John's wort) Thuja occidentalis 8X    (White cedar) Ledum palustre 8X (Wild rosemary) The letters 'HPUS' indicate that the component in this product is officially monographed in the Homeopathic Pharmacopoeia of the United States.

Section 44425-7

Other information

•Store at room temperature

Do not use if bottle seal

is broken or missing.

Section 50565-1

Keep out of reach of children. In case of accidental overdose,

contact a medical professional or a poison control center

immediately.

Section 51727-6

Inactive Ingredients

Purified water, sorbitol, cherry

flavor, sodium benzoate,

potassium sorbate, citric acid.

Section 55105-1

Purpose

Arnica montana 8X.............................................fever, aches & pains, headache, sore throat

(Leopard's bane)

Ferrum phosphoricum 8X.....................................fever, inflammation

(Ferrosoferric phosphate)

Hypericum perforatum 8X....................................pain in the extremeties, toothache, fever

(St. John's wort)

Thuja occidentalis 8X..........................................sinus congestion, headache, muscular pain

(White cedar)

Ledum palustre 8X (Wild rosemary).....................chills and fever

Section 55106-9

Active Ingredients HPUS:

Arnica montana 8X

   (Leopard's bane)

Ferrum phosphoricum 8X

   (Ferrosoferric phosphate)

Hypericum perforatum 8X

   (St. John's wort)

Thuja occidentalis 8X

   (White cedar)

Ledum palustre 8X (Wild rosemary)

The letters 'HPUS' indicate that the component in this product is officially

monographed in the Homeopathic Pharmacopoeia of the United States.

Kids Relief Pain & Fever Oral Liquid


Structured Label Content

Indications and Usage (34067-9)

Uses

This homeopathic medicine is made from a combination of

ingredients traditionally used to help temporarily reduce

fever and relieve minor aches and pains associated with:

   •common cold                  •headache

   •sore throat                     •toothache

Dosage and Administration (34068-7)

Directions

Children under 6 months of age: Consult a licensed healthcare

practitioner before using this product

Children under 6 months to 2 years old: 0.5 ml orally every 8 hours

or 3 times a day

Children 2 to 12 years old: 0.75 ml orally every 8 hours or

3 times a day

Warnings and Precautions (34071-1)

Warnings

Stop use and ask a doctor in cases of high fever or if

symptoms worsen or persist for mroe than 2 days.

Section 44425-7 (44425-7)

Other information

•Store at room temperature

Do not use if bottle 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 a poison control center

immediately.

Section 51727-6 (51727-6)

Inactive Ingredients

Purified water, sorbitol, cherry

flavor, sodium benzoate,

potassium sorbate, citric acid.

Section 55105-1 (55105-1)

Purpose

Arnica montana 8X.............................................fever, aches & pains, headache, sore throat

(Leopard's bane)

Ferrum phosphoricum 8X.....................................fever, inflammation

(Ferrosoferric phosphate)

Hypericum perforatum 8X....................................pain in the extremeties, toothache, fever

(St. John's wort)

Thuja occidentalis 8X..........................................sinus congestion, headache, muscular pain

(White cedar)

Ledum palustre 8X (Wild rosemary).....................chills and fever

Section 55106-9 (55106-9)

Active Ingredients HPUS:

Arnica montana 8X

   (Leopard's bane)

Ferrum phosphoricum 8X

   (Ferrosoferric phosphate)

Hypericum perforatum 8X

   (St. John's wort)

Thuja occidentalis 8X

   (White cedar)

Ledum palustre 8X (Wild rosemary)

The letters 'HPUS' indicate that the component in this product is officially

monographed in the Homeopathic Pharmacopoeia of the United States.

Kids Relief Pain & Fever Oral Liquid


Advanced Ingredient Data


Raw Label Data

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