TUMMY CALM (carbo vegetabilis, chamomilla, lycopodium clavatum, nux moschata, passiflora incarnata, raphanus sativus, sarsaparilla- smilax regelii, zingiber officinale liquid

Tummy Calm by

Drug Labeling and Warnings

Tummy Calm by is a Homeopathic medication manufactured, distributed, or labeled by CalmCo LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS:

Carbo Vegetabilis 1X, Chamomilla 3X, Lycopodium Clavatum 3X, Nux Moschata 3X, Passiflora Incarnata 3X, Raphanus Sativus 3X,

Sarsaparilla (Smilax Regelii) 3X, Zingiber Officinale 3X.

PURPOSE:

Temporarily relieves the symptoms of pediatric:

digestive discomfort  gas  hiccups  reflux

Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

WARNINGS:

Do not use if outer seal on glass bottle or protective wrap on oral dispenser is broken or missing.

Stop use and consult a doctor if symptoms last more than 7 days or inflammation, fever, or infection occurs.

As with all medications, it is important to ensure that your child's medical professional is aware of the use of this product.

Because product is black, a temporary, harmless, darkening of the stool may occur.

May stain fabric; protect clothing and furniture.

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

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.

DIRECTIONS:

        Weight      Dose
Under 20 lbs. (9kg)      1/4 teaspoon (1.25 mL)
Over 20 lbs. (9kg)        1/2 teaspoon (2.5 mL)

Remove outer seal from glass bottle and protective wrap from oral dispenser.

Shake well before use.

Fill enclosed dispenser up to indicated dose level and dispense liquid slowly (drop by drop) into mouth, between cheek and gums.

If needed, repeat every 60 minutes for up to 3 doses. Do not exceed 4 full doses in 24 hours.

Recap bottle and clean dispenser after use.

Discard remaining product after 3 weeks.

INDICATIONS:

Temporarily relieves the symptoms of pediatric:

digestive discomfort gas hiccups reflux

Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

OTHER INFORMATION:

Please note: sleep may follow naturally after relief.

Store at room temperature, out of direct sunlight.

INACTIVE INGREDIENTS:

Citric Acid, Glycerin, Potassium Benzoate, Potassium Citrate, Potassium Sorbate, Purified Water, Xylitol

QUESTIONS:

Distributed by CalmCo LLC

1215 Sarasota Center Blvd. Sarasota FL 34240

Call 941-203-4590 visit www.tummycalm.com

PACKAGE LABEL DISPLAY:

Tummy Calm

For symptomatic relief of

Gas, Upset Stomach,

& Reflux

CalmcCo.

Homeopathic Medicine

2 FL. Oz. (59 mL)

24-47 doses

INGREDIENTS AND APPEARANCE

TUMMY CALM 
carbo vegetabilis, chamomilla, lycopodium clavatum, nux moschata, passiflora incarnata, raphanus sativus, sarsaparilla (smilax regelii), zingiber officinale liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73282-0005
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) (ACTIVATED CHARCOAL - UNII:2P3VWU3H10)	ACTIVATED CHARCOAL	1 [hp_X]  in 1 mL
MATRICARIA CHAMOMILLA WHOLE (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ)	MATRICARIA CHAMOMILLA WHOLE	3 [hp_X]  in 1 mL
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479)	LYCOPODIUM CLAVATUM SPORE	3 [hp_X]  in 1 mL
NUTMEG (UNII: AEE24M3MQ9) (NUTMEG - UNII:AEE24M3MQ9)	NUTMEG	3 [hp_X]  in 1 mL
PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O)	PASSIFLORA INCARNATA FLOWERING TOP	3 [hp_X]  in 1 mL
RADISH (UNII: EM5RP35463) (RADISH - UNII:EM5RP35463)	RADISH	3 [hp_X]  in 1 mL
SMILAX ORNATA ROOT (UNII: 2H1576D5WG) (SARSAPARILLA - UNII:2H1576D5WG)	SMILAX ORNATA ROOT	3 [hp_X]  in 1 mL
GINGER (UNII: C5529G5JPQ) (GINGER - UNII:C5529G5JPQ)	GINGER	3 [hp_X]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
GLYCERIN (UNII: PDC6A3C0OX)
POTASSIUM BENZOATE (UNII: 763YQN2K7K)
POTASSIUM CITRATE (UNII: EE90ONI6FF)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
WATER (UNII: 059QF0KO0R)
XYLITOL (UNII: VCQ006KQ1E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73282-0005-1	1 in 1 CARTON	10/27/2021	11/01/2026
1		59 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		10/27/2021	11/01/2026

Labeler - CalmCo LLC (079308308)

Registrant - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture(73282-0005) , api manufacture(73282-0005) , label(73282-0005) , pack(73282-0005)