Camilia

Camilia
SPL v20
SPL
SPL Set ID 24246729-2d45-4d83-bc25-39db03e266d4
Route
ORAL
Published
Effective Date 2025-05-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Matricaria Recutita (9 [hp_C]) Rhubarb (5 [hp_C]) Phytolacca Americana Root
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Completed Since 2010-12-01 Until 2020-02-27

Description

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.


Medication Information

Warnings and Precautions

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

Indications and Usage

Uses*

temporarily relieves symptoms of teething such as:

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

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.

Dosage Forms and Strengths

Single-use liquid doses

.034 fl oz each

(1mL) each

Description

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.

Section 42229-5

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.

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 doctor if symptoms persist for more than 3 days or worsen, or if swelling, fever, or rash develops.

Section 51727-6

alcohol, purified water

Section 51945-4

Section 53413-1

Camilia.com

BoironUSA.com

[email protected]

1-800-BOIRON-1 (1-800-264-7661)

Distributed by Boiron, Inc. Newtown Square, PA 19073

Made in France

Section 55105-1

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

Section 55106-9

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.


Structured Label Content

Indications and Usage (34067-9)

Uses*

temporarily relieves symptoms of teething such as:

  • painful gums
  • irritability
  • 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.

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.

Dosage Forms and Strengths (34069-5)

Single-use liquid doses

.034 fl oz each

(1mL) each

Warnings and Precautions (34071-1)

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

Section 42229-5 (42229-5)

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.

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 doctor if symptoms persist for more than 3 days or worsen, or if swelling, fever, or rash develops.

Section 51727-6 (51727-6)

alcohol, purified water

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Camilia.com

BoironUSA.com

[email protected]

1-800-BOIRON-1 (1-800-264-7661)

Distributed by Boiron, Inc. Newtown Square, PA 19073

Made in France

Section 55105-1 (55105-1)

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

Section 55106-9 (55106-9)

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.


Advanced Ingredient Data


Raw Label Data

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