Camilia Bedtime

Camilia Bedtime
SPL v6
SPL
SPL Set ID 200c2af6-b457-b8bc-e063-6294a90a3800
Route
ORAL
Published
Effective Date 2025-01-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Phytolacca Americana Root (5 [hp_C]) Matricaria Chamomilla (9 [hp_C]) Rheum Officinale Root (15 [hp_C]) Arabica Coffee Bean
Inactive Ingredients
Alcohol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2024-08-19

Description

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.


Medication Information

Indications and Usage

temporarily relieves nighttime teething symptoms such as:

  • irritability and restlessness
  • painful gums
  • minor digestive upsets associated with teething
Dosage and 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.

Description

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.

Section 42229-5
  • 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 and in the box for no longer than 3 months
  • after opening the vial: use product immediately then discard
  • contains 0.0015% alcohol

5 DOSES .034 FL OZ (1 mL) PER DOSE

30 DOSES .034 FL OZ (1 mL) PER DOSE

40 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.

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50566-9

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

Section 50570-1

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

Section 51727-6

alcohol, purified water

Section 51945-4

Section 53413-1

Camilia.com

Boiron USA.com

[email protected]

1-800-BOIRON-1

(1-800-264-7661)

Section 55105-1

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

Section 55106-9

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.


Structured Label Content

Indications and Usage (34067-9)

temporarily relieves nighttime teething symptoms such as:

  • irritability and restlessness
  • painful gums
  • minor digestive upsets associated with teething
Dosage and Administration (34068-7)

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.

Section 42229-5 (42229-5)
  • 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 and in the box for no longer than 3 months
  • after opening the vial: use product immediately then discard
  • contains 0.0015% alcohol

5 DOSES .034 FL OZ (1 mL) PER DOSE

30 DOSES .034 FL OZ (1 mL) PER DOSE

40 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.

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

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

Section 50570-1 (50570-1)

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

Section 51727-6 (51727-6)

alcohol, purified water

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Camilia.com

Boiron USA.com

[email protected]

1-800-BOIRON-1

(1-800-264-7661)

Section 55105-1 (55105-1)

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

Section 55106-9 (55106-9)

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.


Advanced Ingredient Data


Raw Label Data

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