Label: CAMILIA TUMMY- activated charcoal, matricaria chamomilla, copper, citrullus colocynthis fruit pulp liquid
- NDC Code(s): 0220-9099-07, 0220-9099-09
- Packager: Boiron
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.
Drug Label Information
Updated February 9, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
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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.
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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
- WARNINGS
- DO NOT USE
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions
Children 1 month of age and older: Give 1 does 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
- QUESTIONS
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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
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INGREDIENTS AND APPEARANCE
CAMILIA TUMMY
activated charcoal, matricaria chamomilla, copper, citrullus colocynthis fruit pulp liquidProduct 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)
