Pain and Fever Kids Relief Baby: Homeopathic Product Information

PAIN AND FEVER KIDS RELIEF BABY- 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 8X (Leopard’s bane)

Ferrum phosphoricum 8X (Ferrosoferric phosphate)

Hypericum perforatum 8X (St. John’s Wort)

Belladonna 8X (Deadly nightshade) Calculated as 0,0000003% alkaloids

Thuja occidentalis 8X (White cedar)

Ledum palustre 8X (Wild rosemary)

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
  • sore throat
  • headache
  • toothache

Warnings


Do not use if imprinted seal under bottle cap 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.

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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PAIN AND FEVER KIDS RELIEF BABY
arnica montana, ferrum phosphoricum, hypericum perforatum, belladonna, thuja occidentalis, ledum palustre liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:60512-9201
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 (FERROSOFERRIC PHOSPHATE) 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 ACETATE
Product Characteristics
Color Score
Shape Size
Flavor CHERRY Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60512-9201-8 1 BOTTLE in 1 BOX contains a BOTTLE
1 25 mL in 1 BOTTLE This package is contained within the BOX (60512-9201-8)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 09/01/2016
Labeler — HOMEOLAB USA INC (202032533)
Establishment
Name Address ID/FEI Operations
HOMEOLAB USA INC 202032533 manufacture (60512-9201)

Revised: 09/2016 HOMEOLAB USA INC

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