PAIN AND FEVER KIDS RELIEF BABY- arnica montana, ferrum phosphoricum, hypericum perforatum, belladonna, thuja occidentalis, ledum palustre liquid

Pain and Fever Kids Relief Baby by

Drug Labeling and Warnings

Pain and Fever Kids Relief Baby by is a Homeopathic medication manufactured, distributed, or labeled by HOMEOLAB USA INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

REFERENCES

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

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	8 [hp_X]  in 25 mL
FERRUM PHOSPHORICUM (UNII: 91GQH8I5F7) (FERROSOFERRIC PHOSPHATE - UNII:91GQH8I5F7)	FERRUM PHOSPHORICUM	8 [hp_X]  in 25 mL
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB)	HYPERICUM PERFORATUM	8 [hp_X]  in 25 mL
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H)	ATROPA BELLADONNA	8 [hp_X]  in 25 mL
THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397)	THUJA OCCIDENTALIS LEAFY TWIG	8 [hp_X]  in 25 mL
LEDUM PALUSTRE TWIG (UNII: 877L01IZ0P) (LEDUM PALUSTRE TWIG - UNII:877L01IZ0P)	LEDUM PALUSTRE TWIG	8 [hp_X]  in 25 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
CITRIC ACID ACETATE (UNII: DSO12WL7AU)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60512-9201-8	1 in 1 BOX	09/01/2016
1		25 mL in 1 BOTTLE; Type 0: Not a Combination Product

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	Business Operations
HOMEOLAB USA INC		202032533	manufacture(60512-9201)