Comfort for Colic

Manufacturer
Vitality Works, Inc.
Effective date
2025-12-17
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 02:36:05

Label at a glance#

ProductComfort for Colic
Active ingredientPULSATILLA PRATENSIS, AETHUSA CYNAPIUM, DIOSCOREA VILLOSA TUBER, MAGNESIUM PHOSPHATE, DIBASIC, CHAMOMILE, CITRULLUS COLOCYNTHIS FRUIT
Label structure8 sections

Dosage and administration

Do not use if printed neck seal is broken or missing, use only as directed. For infants up to 3 years of age: give 4 dropsunder the tongue every 30 minutes for 4 doses. Then reduce to once every 4 hours as needed or recommended by a doctor.

Label contents#

Full prescribing information#

Indications

INDICATIONS & USAGE SECTION

For the temporary relief of colic symptoms, including stomach pain, vomiting, gas, cramping and irritability.

OTC - PURPOSE SECTION

For the temporary relief of colic symptoms, including stomach pain, vomiting, gas, cramping and irritability

Directions

DOSAGE & ADMINISTRATION SECTION

Do not use if printed neck seal is broken or missing, use only as directed. For infants up to 3 years of age: give 4 dropsunder the tongue every 30 minutes for 4 doses. Then reduce to once every 4 hours as needed or recommended by a doctor.

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Chamomilla (Chamomile) 4X, Colocynthsis (Bitter cucumber) 4X, Pulsatilla (Wind flower) 4X, Aethusa cynapium (Fools parsley) 6x, Dioscorea villosa (wild yam) 6X, Magnesia Phosphorica (Magensium phophate) 6X

Inactive ingredients

INACTIVE INGREDIENT SECTION

USP Purified water, Vegetable glycerin

Warnings

WARNINGS SECTION

Stop use and ask a doctor if

symptoms do not improve in 7 days or if new symptoms appear

if your child experiences recurring gastrointestinal upsets, frequent headaches or persistent fatigue

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.

Comments or Questions

OTC - QUESTIONS SECTION

Health for Kids Shelbourne Falls, MA 01370 USA

1-800-255-4463

www.herbsforkids.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130701610317648GTIN-13: 0701610317648
EAN-13: 0701610317648
GTIN-12: 701610317648
UPC-A: 701610317648
GTIN storage (14 digits): 00701610317648
label Comfort for colic.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64616-116-01Comfort for Colic30 mL in 1 BOTTLE, DROPPERLIQUID308

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64616-11664616-116-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 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
Comfort for ColicCOMFORT FOR KIDSVitality Works, Inc.220209c1-18ab-1b78-e054-00144ff8d46c2025-12-17WarningsExact identifier
ndc (package): 64616-116-01
ndc (product): 64616-116
ndc11 (package): 64616011601
spl id: 462f5bc0-eea3-2be8-e063-6294a90a958d
spl set id: 220209c1-18ab-1b78-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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