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#

ProductChamomilla
Active ingredientMATRICARIA CHAMOMILLA
Label structure11 sections

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

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FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0220-1253-412023-03-09C16284748780-1f386c649-ef17-0266-e053-dadaa90a7c1aChamomilla 30C
0220-1253-412023-01-30C16284748780-1f386c649-ef17-0266-e053-dadaa90a7c1aChamomilla 30C

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0220-1253-41Chamomilla30 [hp_C] in 1 TUBEPELLET304
0220-1253-43Chamomilla3 in 1 BOXPELLET34

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0220-1253CHAMOMILLA (MATRICARIA CHAMOMILLA ) PELLET [BOIRON]4Current NDC, Legacy NDC, 2 package rows20240724_851978dd-d0dd-208c-e053-2a91aa0a30c5.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0220-12530220-1253-41, 0220-1253-43

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 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
ChamomillaMATRICARIA CHAMOMILLABoiron851978dd-d0dd-208c-e053-2a91aa0a30c52024-07-22Exact identifier
ndc (package): 0220-1253-41
ndc (package): 0220-1253-43
ndc (product): 0220-1253
ndc11 (package): 00220125341
ndc11 (package): 00220125343
spl id: 1dda9eb2-973a-1769-e063-6394a90a43c4
spl set id: 851978dd-d0dd-208c-e053-2a91aa0a30c5

Reported adverse events (FAERS/openFDA)#

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