COUGH AND COLD NIGHTTIME FORMULA KIDS RELIEF

Manufacturer
HOMEOLAB USA INC
Effective date
2017-04-13
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 01:16:55

Label at a glance#

ProductCOUGH AND COLD NIGHTTIME FORMULA KIDS RELIEF
Active ingredientDROSERA ROTUNDIFOLIA FLOWERING TOP, ARNICA MONTANA, BRYONIA ALBA ROOT, CETRARIA ISLANDICA SUBSP. ISLANDICA, PROTORTONIA CACTI, CORALLIUM RUBRUM EXOSKELETON, TIN, MATRICARIA RECUTITA, ARABICA COFFEE BEAN
Label structure9 sections

Indications and uses

This homeopathic medicine is made from a combination of ingredients traditionally used to help relieve symptoms associated with nighttime 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 8 hours or 3 times a day. Children 2 to 12 years old: 5 ml or 1 teaspoon every 8 hours or 3 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

Cetraria islandica (Iceland moss) 1C

Coccus cacti (Cochineal) 3C

Corallium rubrum (Red coral) 3C

Stannum metallicum (Tin) 3C

Chamomilla (German chamomile) 4C

Coffea cruda (Coffee) 4C

Purpose

OTC - PURPOSE SECTION

Dry cough

Aches and pains, chest congestion

Painful cough, Fever

Cough with expectoration

Cough with expectoration

Painful cough

Mucus, cough and chills

Restlessness, irritability and nocturnal awakenings

Restlessness and sleeplessness

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 traditionally used to help relieve symptoms associated with nighttime 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 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 8 hours or 3 times a day.

Children 2 to 12 years old: 5 ml or 1 teaspoon every 8 hours or 3 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

cartoncarton

FDA-Initiated Inactive NDC Indexing#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60512-9212COUGH AND COLD NIGHTTIME FORMULA KIDS RELIEF (DROSERA, ARNICA MONTANA, BRYONIA, CETRARIA ISLANDICA, COCCUS CACTI, CORALLIUM RUBRUM, STANNUM METALLICUM, CHAMOMILLA, COFFEA CRUDA) SYRUP [HOMEOLAB USA INC]2Legacy NDC20170413_2b6ae901-09da-419b-9449-7dfebfc89cd6.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
60512-921260512-9212-5, 60512-9212-4, 60512-9212-9

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 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
46e5d2c0-66a5-4a14-e063-6394a90a160b2b6ae901-09da-419b-9449-7dfebfc89cd62025-12-26WarningsExact identifier
spl set id: 2b6ae901-09da-419b-9449-7dfebfc89cd6

Reported adverse events (FAERS/openFDA)#

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