Pain and Fever Kids Relief Baby

Manufacturer
HOMEOLAB USA INC
Effective date
2016-09-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:24:19

Label at a glance#

ProductPain and Fever Kids Relief Baby
Active ingredientARNICA MONTANA, FERRUM PHOSPHORICUM, HYPERICUM PERFORATUM, ATROPA BELLADONNA, 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 sore throat headache 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 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

OTC - PURPOSE SECTION

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 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
  • sore throat
  • headache
  • toothache

Warnings

WARNINGS SECTION


OTC - DO NOT USE SECTION

Do not use if imprinted seal under bottle cap 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.

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

image descriptionimage description

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
60512-9201-82025-12-28C16284748780-19d75b9cf-ea8f-f424-e053-dadaa90a57ceDRUG FACTS
60512-9201-82020-01-31C16284748780-19d75b9cf-ea8f-f424-e053-dadaa90a57ceDRUG FACTS

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60512-9201PAIN AND FEVER KIDS RELIEF BABY (ARNICA MONTANA, FERRUM PHOSPHORICUM, HYPERICUM PERFORATUM, BELLADONNA, THUJA OCCIDENTALIS, LEDUM PALUSTRE) LIQUID [HOMEOLAB USA INC]1Legacy NDC20160901_509bca6a-3edc-4983-9779-c67a32ccb0c3.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
60512-920160512-9201-8

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

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
46fc046d-0b40-281f-e063-6394a90ac0bb509bca6a-3edc-4983-9779-c67a32ccb0c32025-12-27WarningsExact identifier
spl set id: 509bca6a-3edc-4983-9779-c67a32ccb0c3

Reported adverse events (FAERS/openFDA)#

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