FDA.reportPublic FDA data

Gas and Colic Kids Relief Baby

Manufacturer
HOMEOLAB USA INC
Effective date
2016-08-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:24:19

Label at a glance#

ProductGas and Colic Kids Relief Baby
Active ingredientCITRULLUS COLOCYNTHIS FRUIT PULP, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, MATRICARIA RECUTITA, DIOSCOREA VILLOSA ROOT
Label structure9 sections

Indications and uses

This homeopathic medicine is made from a combination of ingredients traditionally used to help relieve symptoms associated with colic*: • intestinal gas • abdominal pain • bloating • nausea • burping

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 9 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

Colocynthis (Bitter apple) 6X

Magnesia phosphorica (Magnesium hydrogen phosphate) 6X

Chamomilla (German chamomile) 6X

Dioscorea villosa (Wild yam) 6X

Purpose

OTC - PURPOSE SECTION

Abdominal bloating, colic and nausea
Abdominal cramps
Nausea, agitation and irritability
Intestinal gas, burping and colic-like pain

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 relieve symptoms associated with colic*:

• intestinal gas

• abdominal pain

• bloating

• nausea

• burping

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 for more than 2 days.

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 9 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, raspberry and grape 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
60512-9200-82025-12-28C16284748780-19d75b9d0-1642-f424-e053-dadaa90a57ceDRUG FACTS
60512-9200-82020-01-31C16284748780-19d75b9d0-1642-f424-e053-dadaa90a57ceDRUG FACTS

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60512-9200GAS AND COLIC KIDS RELIEF BABY (COLOCYNTHIS, MAGNESIA PHOSPHORICA, CHAMOMILLA, DIOSCOREA VILLOSA) LIQUID [HOMEOLAB USA INC]1Legacy NDC20160901_3ef6a7cf-1d6d-4f42-ba66-b19eaac30bec.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
60512-920060512-9200-8

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
CITRULLUS COLOCYNTHIS FRUIT PULP23H32AOH17ACTIB
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATEHF539G9L3QACTIB
MATRICARIA RECUTITAG0R4UBI2ZZACTIB
DIOSCOREA VILLOSA ROOTIWY3IWX2G8ACTIB
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
46fc046d-0b4e-281f-e063-6394a90ac0bb3ef6a7cf-1d6d-4f42-ba66-b19eaac30bec2025-12-27WarningsExact identifier
spl set id: 3ef6a7cf-1d6d-4f42-ba66-b19eaac30bec

Reported adverse events (FAERS/openFDA)#

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