CAMILIA TUMMY- activated charcoal, matricaria chamomilla, copper, citrullus colocynthis fruit pulp liquid

Camilia Tummy by

Drug Labeling and Warnings

Camilia Tummy 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)

Carbo vegetabilis 6C HPUS (0.25 mL)

Chamomilla 15C HPUS (0.25 mL)

Colocynthis 9C HPUS (0.25 mL)

Cuprum metallicum 6C HPUS (0.25 mL)

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

PURPOSE

Purpose*

Carbo vegetabilis 6C HPUS (0.25 mL) ... Relieves bloating and painful gas

Chamomilla 15C HPUS (0.25 mL) ... Relieves baby colic with fussiness and restlessness

Colocynthis 9C HPUS (0.25 mL) ... Relieves abdominal pain associated with baby colic

Cuprum metallicum 6C HPUS (0.25 mL) ... Relieves abdominal pain associated with baby colic

INDICATIONS & USAGE

Uses*

temporarily relieves gas and colic symptoms such as:

• tummy pain
• bloating
• fussiness and crying
• excessive or painful gas

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.

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

Directions

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 day. For best results, administer before meals.

1. Tear open the foil pouch at the notched edge.

2. Snap off one pre-measured dose.

3. Twist to open.

4. Squeeze entire contents into mouth.

INACTIVE INGREDIENT

alcohol, purified water

QUESTIONS

BoironUSA.com

Info@Boiron.com

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

Made in France

Distributed by Boiron, Inc. Newtown Square, PA 19073

SPL UNCLASSIFIED SECTION

do not use if glued carton end flaps are open or if inner foil pouch and vials are not intact

do not refigerate 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 discard vial

do not reuse

contains 0.0008% alcohol

GAS & COLIC RELIEF*

Fussiness Bloating Painful Gas*

5 Doses

30 Doses

0.034 FL OZ (1 mL) per dose

99.999% ALCOHOL-FREE

*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 TUMMY 
activated charcoal, matricaria chamomilla, copper, citrullus colocynthis fruit pulp liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0220-9099
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ)	MATRICARIA CHAMOMILLA	15 [hp_C]
CITRULLUS COLOCYNTHIS FRUIT PULP (UNII: 23H32AOH17) (CITRULLUS COLOCYNTHIS FRUIT PULP - UNII:23H32AOH17)	CITRULLUS COLOCYNTHIS FRUIT PULP	9 [hp_C]
COPPER (UNII: 789U1901C5) (COPPER - UNII:789U1901C5)	COPPER	6 [hp_C]
ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) (ACTIVATED CHARCOAL - UNII:2P3VWU3H10)	ACTIVATED CHARCOAL	6 [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: 0220-9099-07	5 in 1 POUCH; Type 0: Not a Combination Product	10/02/2023
2	NDC: 0220-9099-09	1 in 1 PACKAGE	10/02/2023
2		30 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		10/02/2023

Labeler - Boiron (282560473)

Registrant - Boiron, Inc. (014892269)

Establishment
Name	Address	ID/FEI	Business Operations
Boiron		383674934	manufacture(0220-9099)