CAMILIA BEDTIME- matricaria chamomilla, arabica coffee bean, phytolacca americana root, rheum officinale root liquid

Camilia Bedtime by

Drug Labeling and Warnings

Camilia Bedtime by is a Homeopathic medication manufactured, distributed, or labeled by Boiron, Boiron, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

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

WARNINGS

DO NOT USE

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

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.

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

QUESTIONS

Camilia.com

Boiron USA.com

Info@Boiron.com

1-800-BOIRON-1

(1-800-264-7661)

SPL UNCLASSIFIED SECTION

• 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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CAMILIA BEDTIME 
matricaria chamomilla, arabica coffee bean, phytolacca americana root, rheum officinale root liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0220-9102
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG)	PHYTOLACCA AMERICANA ROOT	5 [hp_C]
MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ)	MATRICARIA CHAMOMILLA	9 [hp_C]
RHEUM OFFICINALE ROOT (UNII: A47JP5ZG9M) (RHEUM OFFICINALE ROOT - UNII:A47JP5ZG9M)	RHEUM OFFICINALE ROOT	5 [hp_C]
ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72)	ARABICA COFFEE BEAN	15 [hp_C]

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0220-9102-07	1 in 1 BOX	08/19/2024
1		5 in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 0220-9102-09	6 in 1 BOX	08/19/2024
2		5 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		08/19/2024

Labeler - Boiron (282560473)

Registrant - Boiron, Inc. (014892269)

Establishment
Name	Address	ID/FEI	Business Operations
Boiron		383674934	manufacture(0220-9102)