PAIN AND FEVER KIDS RELIEF: Homeopathic Product Information

PAIN AND FEVER KIDS RELIEF- arnica montana, ferrum phosphoricum, hypericum perforatum, atropa belladonna, thuja occidentalis leafy twig and ledum palustre twig liquid
HOMEOLAB USA INC

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Active Ingredients HPUS:

Arnica montana (Leopard’s bane) 8X


Ferrum phosphoricum (Ferrosoferric phosphate) 8X


Hypericum perforatum (St John’s wort) 8X


Belladonna (Deadly nightshade) 8X

Calculated as 0.0000003% alkaloids


Thuja occidentalis (White cedar) 8X


Ledum palustre (Wild rosemary) 8X

Purpose

Fever, aches and pains, headache, sore throat


Fever, inflammation


Pain in the extremities, toothache, fever


Fever, shooting pain, headache, sore throat


Sinus congestion, headache, muscular pain


Chills and fever

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

*These claims have not been reviewed by the Food and Drug Administration. They are based on traditional homeopathic practice.

RETAIN CARTON FOR COMPLETE INSTRUCTIONS

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

Warnings

Do not use if imprinted shrink seal neckband is broken or missing.

Stop use and ask a doctor in cases of high fever or if symptoms worsen or persist.

Keep out of reach of children. In case of accidental overdose, contact a medical profesionnal or a poison control center immediately.

DIRECTIONS

Children under 6 months of age: Consult a licensed healthcare practitioner before using this product.

Children 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.

OTHER INFORMATION

Store at room temperature.

Inactive Ingredients

Purified water, sorbitol, cherry flavor, sodium benzoate, potassium sorbate, citric acid.

CARTON

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LABEL

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PAIN AND FEVER KIDS RELIEF
arnica montana, ferrum phosphoricum, hypericum perforatum, belladonna, thuja occidentalis, ledum palustre liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:60512-9079
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ARNICA MONTANA (ARNICA MONTANA) ARNICA MONTANA 8 [hp_X] in 25 mL
FERRUM PHOSPHORICUM (FERRUM PHOSPHORICUM) FERRUM PHOSPHORICUM 8 [hp_X] in 25 mL
HYPERICUM PERFORATUM (HYPERICUM PERFORATUM) HYPERICUM PERFORATUM 8 [hp_X] in 25 mL
ATROPA BELLADONNA (ATROPA BELLADONNA) ATROPA BELLADONNA 8 [hp_X] in 25 mL
THUJA OCCIDENTALIS LEAFY TWIG (THUJA OCCIDENTALIS LEAFY TWIG) THUJA OCCIDENTALIS LEAFY TWIG 8 [hp_X] in 25 mL
LEDUM PALUSTRE TWIG (LEDUM PALUSTRE TWIG) LEDUM PALUSTRE TWIG 8 [hp_X] in 25 mL
Inactive Ingredients
Ingredient Name Strength
WATER
SORBITOL
SODIUM BENZOATE
POTASSIUM SORBATE
CITRIC ACID MONOHYDRATE
Product Characteristics
Color Score
Shape Size
Flavor CHERRY Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60512-9079-8 1 BOTTLE (BOTTLE) in 1 CARTON contains a BOTTLE
1 25 mL in 1 BOTTLE This package is contained within the CARTON (60512-9079-8)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 05/10/2010
Labeler — HOMEOLAB USA INC (202032533)
Establishment
Name Address ID/FEI Operations
HOMEOLAB USA INC 202032533 manufacture (60512-9079)

Revised: 04/2014 HOMEOLAB USA INC

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