FDA.reportPublic FDA data

KIDS RELIEF COUGH AND COLD

Manufacturer
HOMEOLAB USA INC
Effective date
2017-04-12
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 01:16:56

Label at a glance#

ProductKIDS RELIEF COUGH AND COLD
Active ingredientDROSERA ROTUNDIFOLIA FLOWERING TOP, ARNICA MONTANA, BRYONIA ALBA ROOT, IPECAC, CETRARIA ISLANDICA SUBSP. ISLANDICA, PROTORTONIA CACTI, CORALLIUM RUBRUM EXOSKELETON, TIN
Label structure9 sections

Indications and uses

This homeopathic medicine is made from a combination of ingredients tracitionally used tohelp relieve symptoms associated with cough and cold*: - dry cough - cough with expectoration - chest congestion - fever - aches and pains

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: 2.5 ml or 1/2 teaspoon every 6 hours or 4 times a day. Children 2 to 12 years old: 5 ml or 1 teaspoon every 6 hours or 4 times a day.

Storage and handling

Store at room temperature. Do not use if seal under bottle cap is broken or missing.

Label contents#

Full prescribing information#

Active ingredients HPUS:

OTC - ACTIVE INGREDIENT SECTION

Drosera (Sundew) 1C

Arnica montana (Leopard`s bane) 3C

Bryonia (White bryony) 3C

Ipecacuanha (Ipecac) 3C

Cetraria islandica (Iceland moss) 1C

Coccus cacti (Cochineal) 3C

Corallium rubrum (Red coral) 3C

Stannum metallicum (Tin) 3C

Purpose

OTC - PURPOSE SECTION

Dry cough

Aches and pains, chest congestion

Painful cough, fever

Night cough

Cough with expectoration

Cough with expectoration

Painful cough

Cough, chills and lessens mucus

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.

Uses

INDICATIONS & USAGE SECTION

This homeopathic medicine is made from a combination of ingredients tracitionally used tohelp relieve symptoms associated with cough and cold*:

- dry cough

- cough with expectoration

- chest congestion

- fever

- aches and pains

WARNINGS

WARNINGS SECTION

OTC - STOP USE SECTION

Stop use and ask a doctor if

- pain or cough gets worse or lasts more than 5 days (children) or 7 days (adults)

- fever gets worse or lasts more than 3 days

- redness or swelling is present

- new symptoms occur

- cough comes back or occurs with rash or headache that lasts.

These could be signs of a serious condition.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of accidental overdose, contact a medical professional 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: 2.5 ml or 1/2 teaspoon every 6 hours or 4 times a day.

Children 2 to 12 years old: 5 ml or 1 teaspoon every 6 hours or 4 times a day.

Other information

STORAGE AND HANDLING SECTION

Store at room temperature.

Do not use if seal under bottle cap is broken or missing.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Purified water, sorbitol, caramel, 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
60512-9210-42025-12-31C16284748780-19d75b9d0-ae67-f424-e053-dadaa90a57ceDRUG FACTS
60512-9210-52025-12-31C16284748780-19d75b9d0-ae67-f424-e053-dadaa90a57ceDRUG FACTS
60512-9210-92025-12-31C16284748780-19d75b9d0-ae67-f424-e053-dadaa90a57ceDRUG FACTS
60512-9210-42020-01-31C16284748780-19d75b9d0-ae67-f424-e053-dadaa90a57ceDRUG FACTS
60512-9210-52020-01-31C16284748780-19d75b9d0-ae67-f424-e053-dadaa90a57ceDRUG FACTS
60512-9210-92020-01-31C16284748780-19d75b9d0-ae67-f424-e053-dadaa90a57ceDRUG FACTS

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60512-9210KIDS RELIEF COUGH AND COLD (DROSERA, ARNICA MONTANA, BRYONIA, IPECACUANHA, CETRARIA ISLANDICA, COCCUS CACTI, CORALLIUM RUBRUM, STANNUM METALLICUM) SYRUP [HOMEOLAB USA INC]3Legacy NDC20170412_0584a8b2-a6fa-4d69-a2c5-6feb14e9767b.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
60512-921060512-9210-5, 60512-9210-4, 60512-9210-9

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
DROSERA ROTUNDIFOLIA FLOWERING TOP75O014T1HGACTIB
ARNICA MONTANAO80TY208ZWACTIB
BRYONIA ALBA ROOTT7J046YI2BACTIB
IPECAC62I3C8233LACTIB
CETRARIA ISLANDICA SUBSP. ISLANDICABJ7YPN79A1ACTIB
PROTORTONIA CACTILZB7TFX1LTACTIB
CORALLIUM RUBRUM EXOSKELETON2CA71K0DLEACTIB
TIN387GMG9FH5ACTIB
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
CARAMELT9D99G2B1RIACT
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
46e76816-9164-e38c-e063-6394a90a3d260584a8b2-a6fa-4d69-a2c5-6feb14e9767b2025-12-26WarningsExact identifier
spl set id: 0584a8b2-a6fa-4d69-a2c5-6feb14e9767b

Reported adverse events (FAERS/openFDA)#

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