FDA Label for Camilia Bedtime
View Indications, Usage & Precautions
Camilia Bedtime Product Label
The following document was submitted to the FDA by the labeler of this product Boiron. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active ingredients** (in each 1 mL vial)
Chamomilla 9C HPUS (0.25 mL)
Coffea cruda 15C HPUS (0.25 mL)
Phytolacca decandra 5C HPUS (0.25 mL)
Rheum 5C HPUS (0.25 mL) (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
Purpose*
Chamomilla 9C HPUS (0.25 mL) ... Relieves teething pain accompanied by irritability
Coffea cruda 15C HPUS (0.25 mL) ... Relieves teething pain associated with restlessness
Phytolacca decandra 5C HPUS (0.25 mL) ... Relieves painful gums
Rheum 5C HPUS (0.25 mL) ... Relieves minor digestive upsets associated with teething
Indications & Usage
temporarily relieves nighttime teething symptoms such as:
- irritability and restlessness
- painful gums
- minor digestive upsets associated with teething
Otc - Do Not Use
Do not use if your child has a known allergy to any ingredient in this product.
Otc - Stop Use
Stop use and ask a 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
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Children 1 month of age and older: Give 1 dose at the onset of symptoms at bedtime. Wait 15 minutes, then repeat if needed. Do not exceed 9 doses in 24 hours.
1. Tear open 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 in the mouth.
Inactive Ingredient
alcohol, purified water
Otc - Questions
Camilia.com
Boiron USA.com
1-800-BOIRON-1
(1-800-264-7661)
Other
- do not use if glued carton end flaps are open 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 for no longer than 3 months
- after opening the vial: the product must be used immediately
- after administering vial: discard vial
- do not reuse
- contains 0.0015% alcohol
5 DOSES .034 FL OZ (1 mL) PER DOSE
30 DOSES 034 FL OZ (1 mL) PER DOSE
99.999% ALCOHOL-FREE
Nighttime Teething Relief*
Painful Gums Restlessness*
*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.
* Please review the disclaimer below.
