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

Tummy Calm by

Drug Labeling and Warnings

Tummy Calm by is a Homeopathic medication manufactured, distributed, or labeled by TJL Enterprises Inc., Apotheca Company. 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................................3X

Zingiber Officinale.......................3X

Aloe...........................................4X

USES:

Gas
Bloating
Upset stomach
Hiccups
Teething

WARNINGS:

 Do not use if outer seal imprinted with Tummy Calm logo on bottle or protective wrap on oral dispenser are 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.: 1/4 teaspoon (1.25 mL)
• Over 20 lbs.: 1/2 teaspoon (2.5 mL)

Shake well before use to obtain uniform dark mixture.

Remove outer seal imprinted with Tummy Calm logo from bottle and protective wrap on oral dispenser.

When symptoms occur, fill enclosed oral 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, or as directed by physician. Do not exceed 4 full doses in 24 hours.

Recap bottle and clean oral dispenser.

INDICATIONS:

Temporarily relieves the symptoms of pediatric gas, bloating, upset stomach, hiccups, & teething.

INACTIVE INGREDIENTS:

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

OTHER INFORMATION:

Please note: Sleep may follow naturally after relief.

Store at room temperature, out of direct sunlight.

PATIENT INFORMATION:

Thank you for choosing Tummy Calm homeopathic medicine, the natural

alternative to simethicone for the treatment of digestive discomfort from gas.

Tummy Calm is from the makers of Colic Calm, used by more than a million

babies... and counting. Our products are recommended by pediatricians,

natural health care practitioners and pharmacists.

Tummy Calm is:

Safe, gentle & effective

Non-habit forming or addictive

A smart alternative to synthetic chemicals

Frequently Asked Questions**

What is the purpose of Tummy Calm and is it safe for my child?

Tummy Calm homeopathic medicine provides relief for discomfort from gas,

bloating and upset stomach. Importantly, Tummy Calm is made according

to Good Manufacturing Practices (GMP) for over-the-counter homeopathic

medicines.

What makes Tummy Calm different from simethicone gas drops?

The active ingredients in Tummy Calm provide multi-symptom relief.

According to the principles of homeopathy, each dose gently stimulates the

body’s ability to heal itself, as opposed to merely suppressing symptoms with

synthetic chemicals.

How long will it take to work?

Most children will experience relief with their first dose of Tummy Calm.

However, some may take longer before showing noticeable improvement.

We recommend giving Tummy Calm up to one week to fully work its wonders.

We encourage you to email us at customercare@tummycalm.com or call us at

(877) 321-CALM for helpful customized suggestions that can make a

difference.

What are the directions for use?

At the first signs of digestive discomfort, shake glass bottle to obtain a

uniform dark mixture. Fill enclosed oral dispenser and dispense liquid slowly,

drop-by-drop, into mouth, between cheek and gums. The dosage can also be

mixed with 1 or 2 ounces of water, infant formula or other suitable liquids. Try

not to give Tummy Calm immediately after feeding if baby’s stomach is full, as

spit up may occur from the added pressure.

Additional tip for toddlers & up: Tummy Calm may also be mixed with water,

juice, cereal or other age-appropriate food/drink. Most children enjoy the

sweet non-herbal taste, which blends especially well with juice. Dark juices

and opaque sippy cups work well if Tummy Calm’s dark color is an issue.

If needed, repeat every 60 minutes for up to 3 doses, or as directed by a

physician. Do not exceed the equivalent of 4 full doses for the appropriate

weight category per day. Carefully recap bottle, clean oral dispenser and let

air-dry after each use.

What if my child spits up Tummy Calm?

With infants, some spitting up is normal. One factor is temperature. Some

babies’ stomachs are sensitive to cooler liquids, so Tummy Calm at room

temperature could be unsettling. Tummy Calm may be added to a small

amount (1 or 2 ounces) of warmed formula or pumped breast milk to raise

temperature and change the taste and texture back to something familiar.

Every baby is different, so a little trial and error is sometimes needed. For

toddlers and up, Tummy Calm naturally settles the stomach, so regurgitation

is less likely.

Can my child take other medications while using Tummy Calm?

As with all medications, it is important to ensure that your doctor is aware of

the use of this product. Always check with your doctor if your child is taking

other medications or has been treated for health concerns.

If other medications are being used, allow a two-hour window between the

other medication and Tummy Calm so that the effects of the other medication

are not lessened.

Does Tummy Calm have any side effects?

There are no known contraindications to any of the active ingredients in

Tummy Calm. However, it is always advised that you check with your doctor

before introducing any product.

You may notice a temporary, harmless, darkening of the stool. This occurs

because Tummy Calm uses a form of carbon called Carbo Vegetabilis

(vegetable charcoal). This pure, naturally-produced, non-carcinogenic

vegetable charcoal makes Tummy Calm black in color. Vegetable charcoal

does not enter the bloodstream, and passes out of the body naturally and

easily, along with the gas and toxins it has collected on its journey through the

digestive tract.

What is the best way to get out stains?

Tummy Calm’s rich dark color is as Mother Nature intended, without any

“pretty” coloring to alter its purity and efficacy. While the microfine particles of

vegetable charcoal do not contain any dye, they can get lodged in fabrics and

may require gentle manipulation to loosen. This is why we have included a

stain warning on bottle and box.

We find that stains lift out easily with most spray stain removers. It is best to

treat stains promptly. For stubborn stains, try pre-spotting with

dishwashing liquid before washing. Many parents keep bibs and rags handy

so stain removal doesn’t become an issue.

Can Tummy Calm be used for anything other than gas?

Yes. Tummy Calm is helpful in easing pain associated with the stomach upset

that often accompanies teething. Toddlers and older children benefit from

stomach ache relief. Tummy Calm also provides relief for hiccups.

How long should each bottle last?

Each bottle contains (47) ¼ teaspoon (1.25 ml) doses for infants under 20 lbs.

or (24) ½ teaspoon (2.5 ml) doses for children over 20 lbs. Some children

require more doses than others, depending on the frequency of their

symptoms. Discard glass bottle within three months after opening.

How do I store Tummy Calm?

This product should be stored at room temperature, out of direct sunlight.

Because there is no need for refrigeration, Tummy Calm is also ideal for

traveling away from home.

Why does my child sleep soundly after taking Tummy Calm?

Peaceful sleep often follows naturally after relief. There are no narcotic,

sedative or habit-forming ingredients in Tummy Calm.

* All active ingredients are derived from natural sources.

Tummy_insert_9_15-15indd.indd 1 11/3/2015 12:02:07 PM

** Claims based on traditional homeopathic practice, not accepted medical

evidence. Not FDA evaluated."

313142_TummyCalm.r1.indd 1 7/3/18 7:20 PM

Homeopathy and Dilutions

The homeopathic ingredients in Tummy Calm are diluted either to 1X or 3X

potency. A 1X dilution is obtained by mixing 1 part of the medicinal ingredient

with 9 parts of a neutral diluting agent then vigorously shaking the solution

(succussion). The 3X is obtained by repeating this dilution and succussion

process 3 times. Eight of the nine active ingredients in Tummy Calm operate

according to homeopathic principles at a 3X potency, 1 part per 1,000, or 0.1%.

This level of dilution is found in some non-homeopathic pharmaceuticals in

use today. Drugs such as, Ergocalciferol, are much more diluted than 1 part per

1000.

Unlike most drugs, homeopathic products are not subject to pre-market

approval by the Food and Drug Administration (FDA) and are not reviewed by

the FDA. The FDA has not evaluated this product.

Activated Charcoal

Tummy Calm derives its rich black color from Carbo Vegetabilis 1X (also known

as activated charcoal or medicinal carbon). A 1X dilution is a dilution of one

part per 10. The activated charcoal in Tummy Calm is prepared according to

HPUS methods. Charcoal has been used safely in medicinal applications for

thousands of years.

The activated charcoal in Tummy Calm relieves the bloating and abdominal

discomfort attributable to gaseousness. Charcoal has been shown to relieve

symptoms of gas and upset stomach in several studies and medical texts

including:

i. “Activated charcoal also significantly reduced the number of

volunteers having abdominal symptoms and the symptom score. Our

data clearly indicates that activated charcoal is an effective anti-gas

medication. Simethicone, also commonly prescribed for

gaseousness, was not found to be effective.” - Activated Charcoal,

Simethicone, and Intestinal Gas: A Double-Blind Study by Naresh K. Jain,

M.D., Vijay P. Patel, M.D., and C. S. Pitchumoni, M.D.

ii. “These experiments showed that orally administered activated

charcoal was effective in preventing the large increase in the number

of flatus events and increased breath hydrogen concentrations that

normally occur following a gas-producing meal.” - Effects of Orally

Administered Activated Charcoal on Intestinal Gas by R.J. Hall, E.

Thompson, and A. Strother.

iii. “Symptoms of bloating and abdominal cramps attributable to

gaseousness were also significantly reduced in both groups by

activated charcoal.” - Efficacy of Activated Charcoal in Reducing

Intestinal Gas: a Double-Blind Clinical Trial by Jain NK, Patel VP,

Pitchumoni CS.

iv. “The use of activated charcoal for adsorbing intestinal gas has

been effective in healthy subjects” - Gastrointestinal Gas. Fardy J,

Sullivan S.

v. “Activated charcoal or prokinetic agents also can be effective

options in some patients for intestinal gas.“ - Intestinal Gas by Fink RN,

Lembo AJ.

vi. “The improvement was still evident 2 months after the end of

treatment.” - Efficacy of an activated charcoal / simethicone

combination in dyspeptic syndrome: results of a randomized

prospective study in general practice. Lecuyer M, Cousin T, Monnot MN,

Coffin B.

Each dose of Tummy Calm contains amounts of activated charcoal

corresponding to the amounts used in these efficacy studies, adjusting for the

size of the child.

i. “a child’s drug dose may be weight (in kg) times 2% of an adult

dose” - Calculation of drug dosage and body surface area of children.

J A Lack and M E Stuart-Taylor

Does Tummy Calm work?

While no product can claim to work for everyone, Tummy Calm does have an

impressive track record. Here is what parents are saying:

“We found Tummy Calm to work beautifully within minutes for tummy

troubles in my littlest one and my older sons.”

- S. Negash, PhD, Signal Hill, California

“When my children get gas pains and stomach aches, our no-fail, go-to

remedy is Tummy Calm.”

- A. Uchio, MD, Los Angeles, California

“Colic Calm has worked wonders for my patients and my own child.

I am thrilled that Tummy Calm is now available, too.”

- G. Lejeune, Pediatrician, Shreveport, Louisiana

“Thanks for another awesome product! We loved Colic Calm when our

daughter was a newborn. Now she’s graduated to Tummy Calm. We

appreciate the quality and Ashlei still loves the yummy taste.”

- T. Easton, Vero Beach, Florida

We fully stand behind our product with our money-back guarantee, but realize

that not every child will experience relief from Tummy Calm. We encourage

you to contact our Tummy Calm Customer Care Team for customized

suggestions that can make a difference.

Cease using the product if you do not see noticeable improvement within

one week. Your child simply may not have temporary gas discomfort, or the

condition may be one that Tummy Calm cannot treat. Contact your local

point-of-purchase retailer for an immediate refund. If your retailer does not

provide a refund, contact us for a full refund of the purchase price. Just send

us a copy of the receipt within 30 days of purchase along with the unused

portion and we will refund your purchase and shipping costs. Please visit

www.tummycalm.com/refund for full details on our refund policy.

Refunds available to US customers only.

Do not use Tummy Calm to treat other medical conditions not indicated on

the product packaging. Tummy Calm should not be used to treat chronic

conditions, conditions that are not self-limiting or conditions that require a

doctor’s diagnosis. Conditions unrelated to temporary gassiness that may

cause a child to exhibit discomfort include, but are not limited to lactose

intolerance, cow’s milk allergy, gastrointestinal infections or infections of any

kind, allergies or sensitivities. Always consult your doctor concerning your

child’s health condition and the use of this or any other medicine.

P u r e R e l i e f . N a t u r a l l y.*

®

Learn More About Tummy Calm®

Visit tummycalm.com or contact us directly:

Email customercare@tummycalm.com

Phone (877) 321-CALM

Win $2,500 for Your Home Video

Share a home video of Tummy Calm helping your

child and if your video is selected you will receive

$2,500. Many will enter, many will win!

For easy-to-follow directions visit:

tummycalm.com/homevideo

TJL-005-* All active ingredients are derived from natural sources.

Tummy_insert_9_15-15indd.indd 2 11/3/2015 12:02:07 PM

1X, 3X or 4X

times, and the 4X is obtained by repeating this dilution and succussion

process 4 times. Seven of the nine active ingredients in Tummy Calm operate

according to homeopathic principles at a 3X potency, 1 part per 1,000, or 0.1%.

This level of dilution is found in some non-homeopathic pharmaceuticals in use

today. Drugs such as, Ergocalciferol, are much more diluted than 1 part per 1000.

TC-IN-006-01

** Claims based on traditional homeopathic practice, not accepted medical

evidence. Not FDA evaluated."

313142_TummyCalm.r1.indd 2 7/3/18 7:20 PM

QUESTIONS:

Distributed by TJL Enterprises, Inc.

Long Beach, CA 90803

www.tummycalm.com (877) 321-CALM

PACKAGE LABEL DISPLAY:

HOMEOPATHIC MEDICINE            NDC: 13992-006-01

Tummy Calm                  From the makers of Colic Calm

Pure &

Natural

Gas

Relief

FOR

INFANTS

& CHILDREN

Safe & Gentle Fast Acting Great Tasting

THE SMART ALTERNATIVE

TO SIMETHICONE

USE ONLY WHEN NEEDED

24-47 Doses    Oral Suspension    2 fl. oz. (59 mL)

INGREDIENTS AND APPEARANCE

TUMMY CALM 
aloe, carbo vegetabilis, chamomilla, lycopodium clavatum, nux moschata, passiflora incarnata, raphanus sativus, sarsaparilla, zingiber officinale liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13992-006
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
CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X)	CHAMOMILE	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 REGELII ROOT (UNII: 2H1576D5WG) (SARSAPARILLA - UNII:2H1576D5WG)	SMILAX REGELII ROOT	3 [hp_X]  in 1 mL
GINGER (UNII: C5529G5JPQ) (GINGER - UNII:C5529G5JPQ)	GINGER	3 [hp_X]  in 1 mL
ALOE (UNII: V5VD430YW9) (ALOE - UNII:V5VD430YW9)	ALOE	4 [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: 13992-006-01	1 in 1 CARTON	08/09/2018
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		08/09/2018

Labeler - TJL Enterprises Inc. (004042785)

Registrant - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture(13992-006) , api manufacture(13992-006) , label(13992-006) , pack(13992-006)