The following Structured Product Label (SPL) was submitted to the FDA by Boiron for the product Camilia Bedtime (NDC 0220-9102). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, otc - do not use, otc - stop use, otc - keep out of reach of children, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
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.
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
temporarily relieves nighttime teething symptoms such as:
Do not use if your child has a known allergy to any ingredient in this product.
Stop use and ask a doctor if symptoms persist for more than 3 days or worsen, or if swelling, fever, or rash develops.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
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.
alcohol, purified water
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.
