Chamomilla
- Manufacturer
- Boiron | Boiron, Inc.
- Effective date
- 2024-07-22
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- full-release
- Hydrated at
- 2026-06-01 02:27:36
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Chamomilla 30C HPUS
(**contains 0.443 mg of the active ingredient per pellet)
The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.
OTC - PURPOSE SECTION
Relieves hypersensitivity to pain, irritability, restlessness, especially during teething
INDICATIONS & USAGE SECTION
Teething Relief Uses*
temporarily relieves teething symptoms such as
- pain
- irritability
- restlessness
Tube Uses*
Relieves teething pain with irritability *
OTC - STOP USE SECTION
Teething Relief Box
Stop use and ask a doctor if symptoms persist for more than 3 days or worsen, or if swelling, fever, or rash develops.
Tube
Stop use and ask a doctor if symptoms persist for more than 3 days or worsen.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
SPL UNCLASSIFIED SECTION
Teething Relief Box
Teething Relief*
Pain Irritability Restlessness*
3 Tubes
Approx 80 pellets each
16 Doses per tube
Total 240 pellets
do not use if glued carton end flaps are open or if pellet dispenser seal is broken
contains 0.25 g of sugar per dose
retain carton for full drug facts
Turn tube upside down, Twist until 5 pellets are dispensed. Remove the cap and use it to pour pellets under tongue.
Tube
Do not use if pellet dispenser seal is broken.
Contains approx 80 pellets.
How to dispense pellets? Turn tube upside down. Twist until 5 pellets are dispensed into cap. Carefully remove the cap and use it to pour pellets under the tongue.
*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.
INACTIVE INGREDIENT SECTION
lactose, sucrose
DOSAGE & ADMINISTRATION SECTION
Teething Relief Box
Adults and children 2 years of age and older: At the onset of symptoms, dissolve 5 pellets under the tongue up to 3 times per day. Decrease frequency with improvement.
Children under 2 years of age: Ask a doctor.
Tube
Adults and children: At the onset of symptoms, dissolve 5 pellets under the tongue 3 times a day until symptoms are relieved or as directed by a doctor.
OTC - QUESTIONS SECTION
BoironUSA.com Info@boiron.com
1-800-BOIRON-1
(1-800-264-7661)
Distributed by Boiron, Inc.
Newtown Square, PA 19073
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0220-1253-41 | 2023-03-09 | C162847 | 48780-1 | f386c649-ef17-0266-e053-dadaa90a7c1a | Chamomilla 30C |
| 0220-1253-41 | 2023-01-30 | C162847 | 48780-1 | f386c649-ef17-0266-e053-dadaa90a7c1a | Chamomilla 30C |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0220-1253-41 | Chamomilla | 30 [hp_C] in 1 TUBE | PELLET | 30 | 4 | |
| 0220-1253-43 | Chamomilla | 3 in 1 BOX | PELLET | 3 | 4 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Chamomilla
- MATRICARIA CHAMOMILLA
- LACTOSE, UNSPECIFIED FORM
- ANHYDROUS LACTOSE
- SUCROSE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0220-1253 | 0220-1253-41, 0220-1253-43 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| MATRICARIA CHAMOMILLA | G0R4UBI2ZZ | ACTIB |
| LACTOSE, UNSPECIFIED FORM | J2B2A4N98G | IACT |
| SUCROSE | C151H8M554 | 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 |
|---|---|---|---|---|---|---|
| Chamomilla | MATRICARIA CHAMOMILLA | Boiron | 851978dd-d0dd-208c-e053-2a91aa0a30c5 | 2024-07-22 | 0220-1253-41 0220-1253-43 0220-1253 00220125341 00220125343 1dda9eb2-973a-1769-e063-6394a90a43c4 851978dd-d0dd-208c-e053-2a91aa0a30c5 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.


