Camilia
Camilia
24246729-2d45-4d83-bc25-39db03e266d4
HUMAN OTC DRUG LABEL
May 27, 2025
Laboratoires Boiron
DUNS: 282560473
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
MATRICARIA RECUTITA, RHUBARB, PHYTOLACCA AMERICANA ROOT
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (5)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
INDICATIONS & USAGE SECTION
Uses*
temporarily relieves symptoms of teething such as:
- painful gums
- irritability
- minor digestive upsets associated with teething
OTC - STOP USE SECTION
Stop use and ask doctor ifsymptoms persist for more than 3 days or worsen, or if swelling, fever, or rash develops.
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
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
WARNINGS SECTION
Do not use ifyour child has a known allergy to any ingredient in this product.
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.
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
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