KIDS RELIEF PAIN AND FEVER- arnica montana, ferrum phosphoricum, hypericum perforatum, 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 (Leopard's bane) 8X


Ferrum phosphoricum (Ferrosoferric phosphate) 8X


Hypericum perforatum (St John's wort) 8X

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

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 on bottle 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

carton

KIDS RELIEF PAIN AND FEVER 
arnica montana, ferrum phosphoricum, hypericum perforatum, thuja occidentalis, ledum palustre liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60512-9216
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) (FERRUM PHOSPHORICUM - UNII:91GQH8I5F7) FERRUM PHOSPHORICUM8 [hp_X]  in 25 mL
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM8 [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 MONOHYDRATE (UNII: 2968PHW8QP)  
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60512-9216-81 in 1 CARTON10/21/2016
125 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic10/21/2016
Labeler - HOMEOLAB USA INC (202032533)
Establishment
NameAddressID/FEIBusiness Operations
HOMEOLAB USA INC202032533manufacture(60512-9216)

Revised: 4/2017
Document Id: a445c1c9-f9e9-482c-86a6-8257fdbfef87
Set id: c0a0430a-a583-4bfa-9291-26b9e8840d9c
Version: 3
Effective Time: 20170413
 
HOMEOLAB USA INC