Coliccomfort

Coliccomfort
SPL v3
SPL
SPL Set ID 74aa5ab4-cd93-36b0-e053-2991aa0a1068
Route
ORAL
Published
Effective Date 2020-03-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Activated Charcoal (5 [hp_C]) Copper (9 [hp_C]) Citrullus Colocynthis Fruit
Inactive Ingredients
Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Completed Since 2018-09-15 Until 2029-10-31

Description

Carbo vegetabilis 5C HPUS Colocynthis 9C HPUS Cuprum metallicum 5C HPUS


Medication Information

Indications and Usage

Temporarily relieves symptoms associated with baby colic such as gas pain, irritability, stomach cramps, bloating, hiccups

Dosage and Administration

Children 1 month of age and older: Give 1 dose at the onset of symptoms, Wait 15 minutes, then repeate if needed for up to a total of 9 doses per day. For best results administer before meals.

Tear open the foil pouch at the notched edge, Snap off one pre-measured dose, twist open, squeeze entire contents into mouth.

Dosage Forms and Strengths

30 doses of 0.34 fl. oz. each

Description

Carbo vegetabilis 5C HPUS Colocynthis 9C HPUS Cuprum metallicum 5C HPUS

Section 42229-5

contains 0.31% alcohol

The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

*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 44425-7

After opening the foil pack: store the unused doses in the foil pack at a temperature that does noe exceed 77 F (25 C)

After opening the vial: the product must be used immediately

After administrating: discal vial

Section 50565-1

Keep out of reach of children. In case of accidental 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.

Section 50567-7

After administering, discard single use container.

Do not reuse.

After opening the single dose, the product must be used immediately. After administering, discard single use container. Do not reuse.

Section 50569-3

Stop use and ask a doctor if symptoms persist for more than 3 days or worsen.

Section 50570-1

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

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

Do not reuse

Section 51727-6

alcohol, purified water

Section 51945-4

Section 53413-1

Questions or comments?

BoironUSA.com

[email protected]

1-800-BOIRON-1

(1-800-264-7661)

Distributed by Boiron Inc.

Section 53414-9

NA

Section 55105-1

Carbo vegetabilis 5C HPUS .................relieves bloating associated with colic

Colocynthis 9C HPUS .....................relieves cramping pains associated with colic

Cuprum metallicum 5C HPUS ..........relieves abdominal cramps associated with colic

Section 55106-9

Carbo vegetabilis 5C HPUS

Colocynthis 9C HPUS

Cuprum metallicum 5C HPUS


Structured Label Content

Indications and Usage (34067-9)

Temporarily relieves symptoms associated with baby colic such as gas pain, irritability, stomach cramps, bloating, hiccups

Dosage and Administration (34068-7)

Children 1 month of age and older: Give 1 dose at the onset of symptoms, Wait 15 minutes, then repeate if needed for up to a total of 9 doses per day. For best results administer before meals.

Tear open the foil pouch at the notched edge, Snap off one pre-measured dose, twist open, squeeze entire contents into mouth.

Dosage Forms and Strengths (34069-5)

30 doses of 0.34 fl. oz. each

Section 42229-5 (42229-5)

contains 0.31% alcohol

The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

*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 44425-7 (44425-7)

After opening the foil pack: store the unused doses in the foil pack at a temperature that does noe exceed 77 F (25 C)

After opening the vial: the product must be used immediately

After administrating: discal vial

Section 50565-1 (50565-1)

Keep out of reach of children. In case of accidental 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.

Section 50567-7 (50567-7)

After administering, discard single use container.

Do not reuse.

After opening the single dose, the product must be used immediately. After administering, discard single use container. Do not reuse.

Section 50569-3 (50569-3)

Stop use and ask a doctor if symptoms persist for more than 3 days or worsen.

Section 50570-1 (50570-1)

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

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

Do not reuse

Section 51727-6 (51727-6)

alcohol, purified water

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments?

BoironUSA.com

[email protected]

1-800-BOIRON-1

(1-800-264-7661)

Distributed by Boiron Inc.

Section 53414-9 (53414-9)

NA

Section 55105-1 (55105-1)

Carbo vegetabilis 5C HPUS .................relieves bloating associated with colic

Colocynthis 9C HPUS .....................relieves cramping pains associated with colic

Cuprum metallicum 5C HPUS ..........relieves abdominal cramps associated with colic

Section 55106-9 (55106-9)

Carbo vegetabilis 5C HPUS

Colocynthis 9C HPUS

Cuprum metallicum 5C HPUS


Advanced Ingredient Data


Raw Label Data

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