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

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DRUG FACTS

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*:

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:60512-9201
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA8 [hp_X]  in 25 mL
FERRUM PHOSPHORICUM (UNII: 91GQH8I5F7) (FERROSOFERRIC PHOSPHATE - UNII:91GQH8I5F7) FERRUM PHOSPHORICUM8 [hp_X]  in 25 mL
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM8 [hp_X]  in 25 mL
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA8 [hp_X]  in 25 mL
THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397) THUJA OCCIDENTALIS LEAFY TWIG8 [hp_X]  in 25 mL
LEDUM PALUSTRE TWIG (UNII: 877L01IZ0P) (LEDUM PALUSTRE TWIG - UNII:877L01IZ0P) LEDUM PALUSTRE TWIG8 [hp_X]  in 25 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60512-9201-81 in 1 BOX09/01/2016
125 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic09/01/2016
Labeler - HOMEOLAB USA INC (202032533)
Establishment
NameAddressID/FEIBusiness Operations
HOMEOLAB USA INC202032533manufacture(60512-9201)

Revised: 9/2016
Document Id: 43ba057b-7be2-454e-a587-ce5176ef7509
Set id: 509bca6a-3edc-4983-9779-c67a32ccb0c3
Version: 1
Effective Time: 20160901
 
HOMEOLAB USA INC