Storage and handling
After opening the foil pack: store the unused doses in the foil pack at a temperature that does noe exceed 77 F (25 C) After opening the vial: the product must be used immediately After administrating: discal vial
ColicComfort
- Manufacturer
- Boiron
- Effective date
- 2024-06-11
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-06-01 02:27:21
Label at a glance#
ProductColicComfort
Active ingredientACTIVATED CHARCOAL, COPPER, CITRULLUS COLOCYNTHIS FRUIT
Label structure16 sections
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Carbo vegetabilis 5C HPUS
Colocynthis 9C HPUS
Cuprum metallicum 5C HPUS
INDICATIONS & USAGE SECTION
Temporarily relieves symptoms associated with baby colic such as gas pain, irritability, stomach cramps, bloating, hiccups
OTC - DO NOT USE SECTION
Do not use if your child has a known allergy to any ingredient in this product.
Do not use if glued carton end flaps are open or if inner foil pouch and vials are not intact
Do not refrigerate or freeze
Do not reuse
DOSAGE & ADMINISTRATION SECTION
Children 1 month of age and older: Give 1 dose at the onset of symptoms, Wait 15 minutes, then repeate if needed for up to a total of 9 doses per day. For best results administer before meals.
Tear open the foil pouch at the notched edge, Snap off one pre-measured dose, twist open, squeeze entire contents into mouth.
INACTIVE INGREDIENT SECTION
alcohol, purified water
HOW SUPPLIED SECTION
30 doses of 0.34 fl. oz. each
OTC - PURPOSE SECTION
Carbo vegetabilis 5C HPUS .................relieves bloating associated with colic
Colocynthis 9C HPUS .....................relieves cramping pains associated with colic
Cuprum metallicum 5C HPUS ..........relieves abdominal cramps associated with colic
STORAGE AND HANDLING SECTION
After opening the foil pack: store the unused doses in the foil pack at a temperature that does noe exceed 77 F (25 C)
After opening the vial: the product must be used immediately
After administrating: discal vial
OTC - QUESTIONS SECTION
Questions or comments?
BoironUSA.com
Info@Boiron.com
1-800-BOIRON-1
(1-800-264-7661)
Distributed by Boiron Inc.
OTC - ASK DOCTOR SECTION
Stop use and ask a doctor if symptoms persist for more than 3 days or worsen.
OTC - STOP USE SECTION
Stop use and ask doctor if symptoms persist for more than 3 days or worsen.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.
OTC - PREGNANCY OR BREAST FEEDING SECTION
NA
OTC - WHEN USING SECTION
After administering, discard single use container.
Do not reuse.
After opening the single dose, the product must be used immediately. After administering, discard single use container. Do not reuse.
SPL UNCLASSIFIED SECTION
contains 0.31% alcohol
The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.
*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.
**C,K,CK, and X are homeopathic dilutions: see BoironUSA.com/info for details.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| c599c4a0-705d-4ebb-ab1f-977af038f96a | Product name | 1 | 20251124 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0220-9074-09 | 2024-06-11 | C162847 | 48780-1 | f386c64a-31b8-0266-e053-dadaa90a7c1a | ColicComfort |
| 0220-9074-09 | 2023-01-30 | C162847 | 48780-1 | f386c64a-31b8-0266-e053-dadaa90a7c1a | ColicComfort |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0220-9074-09 | ColicComfort | 30 in 1 BOX | LIQUID | 30 | 3 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- ColicComfort
- ACTIVATED CHARCOAL, COPPER, CITRULLUS COLOCYNTHIS FRUIT
- ACTIVATED CHARCOAL
- COPPER
- CITRULLUS COLOCYNTHIS FRUIT
- WATER
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0220-9074 | 0220-9074-09 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACTIVATED CHARCOAL | 2P3VWU3H10 | ACTIB |
| COPPER | 789U1901C5 | ACTIB |
| CITRULLUS COLOCYNTHIS FRUIT | 0E49E3V9U6 | ACTIB |
| WATER | 059QF0KO0R | IACT |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| ColicComfort | ACTIVATED CHARCOAL, COPPER, CITRULLUS COLOCYNTHIS FRUIT | Boiron | 74aa5ab4-cd93-36b0-e053-2991aa0a1068 | 2024-06-11 | 0220-9074-09 0220-9074 00220907409 1a9e144b-7444-dc58-e063-6394a90a6ca0 74aa5ab4-cd93-36b0-e053-2991aa0a1068 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.