FDA.reportPublic FDA data

Camilia

Manufacturer
Laboratoires Boiron | Boiron Inc. | Boiron
Effective date
2025-05-27
Label type
HUMAN OTC DRUG LABEL
Version
20
Source
full-release
Hydrated at
2026-06-01 02:33:44

Label at a glance#

ProductCamilia
Active ingredientMATRICARIA RECUTITA, RHUBARB, PHYTOLACCA AMERICANA ROOT
Label structure12 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients** (in each 1 mL vial)

Chamomilla 9C HPUS (0.33mL)
Phytolacca decandra 5C HPUS (0.33mL)
Rheum 5C HPUS (0.33mL) (contains less than 10 -9 mg anthraquinone glycosides)

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

OTC - PURPOSE SECTION

Purpose*

Chamomilla 9C HPUS (0.33mL) ... Relieves teething pain accompanied by irritability
Phytolacca decandra 5C HPUS (0.33mL) ... Relieves painful gums
Rheum 5C HPUS (0.333mL) ... Relieves minor digestive upsets associated with teething

INDICATIONS & USAGE SECTION

Uses*

temporarily relieves symptoms of teething such as:

  • painful gums
  • irritability
  • minor digestive upsets associated with teething

WARNINGS SECTION

Do not use if your child has a known allergy to any ingredient in this product.

OTC - STOP USE SECTION

Stop use and ask doctor if symptoms persist for more than 3 days or worsen, or if swelling, fever, or rash develops.

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.

DOSAGE & ADMINISTRATION SECTION

Children 1 month of age and older:

Give 1 dose at the onset of symptoms.

Wait 15 minutes, then repeat if needed for up to a total of 9 doses per 24 hours.

1. Tear open the foil pouch at the notched edge.

2. Snap off one pre-measured dose.

3. Twist to open.

4. Holding the child upright, squeeze entire contents into mouth.

INACTIVE INGREDIENT SECTION

alcohol, purified water

SPL UNCLASSIFIED SECTION

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

after opening foil pouch: store unused vials in the foil pouch and in the box for no longer than 3 months

after opening the vial: use product immediately then discard

contains less than 0.0015% alcohol

Teething Relief*

Painful Gums Irritability*

*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.

HOW SUPPLIED SECTION

Single-use liquid doses

.034 fl oz each
(1mL) each

OTC - QUESTIONS SECTION

Camilia.com

BoironUSA.com

Info@Boiron.com

1-800-BOIRON-1 (1-800-264-7661)

Distributed by Boiron, Inc. Newtown Square, PA 19073

Made in France

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

0404

0404

0404

0404

0404

0404

0404

0404

0404

0404

0404

0404

0404

0404

0404

0404

0404

0404

04170417

0404

04170417

04170417

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0220-9054-07Camilia5 in 1 POUCHLIQUID520
0220-9054-07Camilia1 in 1 PACKAGELIQUID120
0220-9054-08Camilia15 in 1 POUCHLIQUID1520
0220-9054-08Camilia1 in 1 PACKAGELIQUID120
0220-9054-09Camilia30 in 1 POUCHLIQUID3020
0220-9054-09Camilia1 in 1 PACKAGELIQUID120
0220-9054-10Camilia150 in 1 CARTONLIQUID15020
0220-9054-10Camilia5 in 1 POUCHLIQUID520
0220-9054-46Camilia1 in 1 PACKAGELIQUID120
0220-9054-46Camilia10 in 1 POUCHLIQUID1020
0220-9054-47Camilia40 in 1 POUCHLIQUID4020
0220-9054-47Camilia1 in 1 PACKAGELIQUID120

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0220-9054CAMILIA (MATRICARIA RECUTITA, RHUBARB, PHYTOLACCA AMERICANA ROOT) LIQUID [LABORATOIRES BOIRON]20Current NDC, Legacy NDC, 12 package rows20250529_24246729-2d45-4d83-bc25-39db03e266d4.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
MATRICARIA RECUTITAACTIVE INGREDIENTG0R4UBI2ZZ3
PHYTOLACCA AMERICANA ROOTACTIVE INGREDIENT11E6VI8VEG3
RHUBARBACTIVE INGREDIENTG280W4MW6E3
MATRICARIA RECUTITAACTIVE MOIETYG0R4UBI2ZZ3
PHYTOLACCA AMERICANA ROOTACTIVE MOIETY11E6VI8VEG3
RHUBARBACTIVE MOIETYG280W4MW6E3
WATERINACTIVE INGREDIENT059QF0KO0R3

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0220-90540220-9054-46, 0220-9054-07, 0220-9054-10, 0220-9054-47, 0220-9054-08, 0220-9054-09

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
MATRICARIA RECUTITAG0R4UBI2ZZACTIB
RHUBARBG280W4MW6EACTIB
PHYTOLACCA AMERICANA ROOT11E6VI8VEGACTIB
ALCOHOL3K9958V90MIACT

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
CamiliaMATRICARIA RECUTITA, RHUBARB, PHYTOLACCA AMERICANA ROOTLaboratoires Boiron24246729-2d45-4d83-bc25-39db03e266d42025-05-27WarningsExact identifier
ndc (package): 0220-9054-07
ndc (package): 0220-9054-46
ndc (package): 0220-9054-08
ndc (package): 0220-9054-10
ndc (package): 0220-9054-09
ndc (package): 0220-9054-47
ndc (product): 0220-9054
ndc11 (package): 00220905407
ndc11 (package): 00220905408
ndc11 (package): 00220905446
ndc11 (package): 00220905447
ndc11 (package): 00220905410
ndc11 (package): 00220905409
spl id: 3625289a-4a21-c6f9-e063-6394a90a992f
spl set id: 24246729-2d45-4d83-bc25-39db03e266d4

Reported adverse events (FAERS/openFDA)#

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