INFANTS GAS AND COLIC RELIEF

Manufacturer
Laboratoire Atlas Inc
Effective date
2025-10-08
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 02:37:28

Label at a glance#

ProductINFANTS GAS AND COLIC RELIEF
Active ingredientCITRULLUS COLOCYNTHIS FRUIT PULP, MAGNESIUM PHOSPHATE, DIBASIC, CHAMOMILE, DIOSCOREA VILLOSA ROOT
Label structure8 sections

Indications and uses

This homeopathic medicine is made from a combination of ingredients traditionnally used to help relieve symptoms associated with colic: • intestinal gas • abdominal pain • bloating & hiccups • nausea • burping • upset stomach *These claims have not been reviewed by the Food and Drug Administration. They are based on traditional homeopathic practice.

Dosage and administration

• Do not use more than directed. • Take 0.75 mL orally at the onset of symptoms. • Repeat every 15 minutes up to 4 times daily, then reduce with improvement or as directed by a healthcare professional. Age                                                                          Dose Infants and children 0 to 9 years of age                     0.75 mL

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

*The letters "HPUS" indicate that the components in this product are officially monographed in the Homoeopathic Pharmacopoeia of the United States.

Purpose

OTC - PURPOSE SECTION

Colocynthis (Bitter apple) 6X.......................................................................upset stomach, abdominal bloating, colic and nausea

Magnesia phosphorica (Magnesium hydrogen phosphate) 6X...........................abdominal cramps

Chamomilla (German chamomile) 6X............................................................hiccups, nausea, agitation and irritability

Dioscorea villosa (Wild yam) 6X...................................................................intestinal gas, burping and colic-like pain

Uses

INDICATIONS & USAGE SECTION

This homeopathic medicine is made from a combination of ingredients traditionnally used to help relieve symptoms associated with colic:

• intestinal gas

• abdominal pain

• bloating & hiccups

• nausea

• burping

• upset stomach

*These claims have not been reviewed by the Food and Drug Administration. They are based on traditional homeopathic practice.

Warnings

WARNINGS SECTION

OTC - DO NOT USE SECTION

Do not use if inner foil seal 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

• Do not use more than directed.

• Take 0.75 mL orally at the onset of symptoms.

• Repeat every 15 minutes up to 4 times daily, then reduce with improvement or as directed by a healthcare professional.


Age                                                                          Dose

Infants and children 0 to 9 years of age                     0.75 mL

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 of cartonimage of carton

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63388-643-02INFANTS GAS AND COLIC RELIEF1 in 1 CARTONLIQUID16
63388-643-02INFANTS GAS AND COLIC RELIEF25 mL in 1 BOTTLELIQUID256

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63388-64363388-643-02

Ingredients#

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

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

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
52024-11-26full-release2026-06-01 02:29:08

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
INFANTS GAS AND COLIC RELIEFCOLOCYNTHIS, MAGNESIA PHOSPHORICA, CHAMOMILLA, DIOSCOREA VILLOSALaboratoire Atlas Incfeb6c271-182d-4a4c-bb2d-d1a87c76c7ef2025-10-08WarningsExact identifier
ndc (package): 63388-643-02
ndc (product): 63388-643
ndc11 (package): 63388064302
spl id: 40aab71f-dd59-795e-e063-6394a90a75ab
spl set id: feb6c271-182d-4a4c-bb2d-d1a87c76c7ef

Reported adverse events (FAERS/openFDA)#

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