FDA.reportPublic FDA data

KIDS RELIEF PAIN AND FEVER

Manufacturer
HOMEOLAB USA INC
Effective date
2017-04-13
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 01:16:54

Label at a glance#

ProductKIDS RELIEF PAIN AND FEVER
Active ingredientARNICA MONTANA, FERRUM PHOSPHORICUM, HYPERICUM PERFORATUM, THUJA OCCIDENTALIS LEAFY TWIG, LEDUM PALUSTRE TWIG
Label structure9 sections

Indications and 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

Dosage and administration

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.

Storage and handling

Store at room temperature.

Label contents#

Full prescribing information#

Active Ingredients HPUS:

OTC - ACTIVE INGREDIENT SECTION

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

OTC - PURPOSE SECTION

Fever, aches and pains, headache, sore throat


Fever, inflammation


Pain in the extremities, toothache, fever

Sinus congestion, headache, muscular pain


Chills and fever

REFERENCES SECTION

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

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

OTC - DO NOT USE SECTION

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

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

Store at room temperature.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

CARTON

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

cartoncarton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
60512-9216-82025-12-27C16284748780-19d75b9d0-d9c9-f424-e053-dadaa90a57ceDRUG FACTS
60512-9216-82020-01-31C16284748780-19d75b9d0-d9c9-f424-e053-dadaa90a57ceDRUG FACTS

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60512-9216KIDS RELIEF PAIN AND FEVER (ARNICA MONTANA, FERRUM PHOSPHORICUM, HYPERICUM PERFORATUM, THUJA OCCIDENTALIS, LEDUM PALUSTRE) LIQUID [HOMEOLAB USA INC]3Legacy NDC20170414_c0a0430a-a583-4bfa-9291-26b9e8840d9c.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
60512-921660512-9216-8

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
ARNICA MONTANAO80TY208ZWACTIB
FERRUM PHOSPHORICUM91GQH8I5F7ACTIB
HYPERICUM PERFORATUMXK4IUX8MNBACTIB
THUJA OCCIDENTALIS LEAFY TWIG1NT28V9397ACTIB
LEDUM PALUSTRE TWIG877L01IZ0PACTIB
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
SODIUM BENZOATEOJ245FE5EUIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
46f4b7ad-30da-c135-e063-6394a90a95d9c0a0430a-a583-4bfa-9291-26b9e8840d9c2025-12-27WarningsExact identifier
spl set id: c0a0430a-a583-4bfa-9291-26b9e8840d9c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.