COLIC CALM- carbo vegetabilis, carum carvi, chamomilla, foeniculum vulgare, melissa officinalis, mentha piperita, prunus spinosa, zingiber officinale liquid

Colic Calm by

Drug Labeling and Warnings

Colic 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
Carum Carvi..........................3X
Chamomilla...........................3X
Foeniculum Vulgare..............3X
Melissa Officinalis................3X
Mentha Piperita.....................3X
Prunus Spinosa......................3X
Zingiber Officinale................3X

Uses:

Temporarily relieves the symptoms of infant:
gas  colic  upset stomach  bloating  hiccups

*These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

Indications:

Temporarily relieves the symptoms of infant:
gas colic upset stomach bloating hiccups

*These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

Warnings:

Do not use if outer seal imprinted with Colic Calm logo 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 temporarily, harmless, darkening of the stool may occur.

May stain fabric; protect clothing and furniture.

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 Colic Calm logo from glass 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 a physician. Do not exceed 4 full doses in 24 hours.

Recap glass bottle and clean oral dispenser.

Discard 8 weeks after opening.

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:

Questions or comments?

Call (877)321-CALM

Visit us at

coliccalm.com

Or ask your physician, health care practitioner or pharmacist.

Patient information:

Relief. Pure & Simple.

Thank you for choosing Colic Calm, the first homeopathic gripe water for the treatment of colic, gas and upset stomach.  Our product has been used by more than a million babies…and counting. In fact, it is recommended by pediatricians, natural health care practitioners, and pharmacists.

Colic Calm is:

  Safe, gentle and effective
  Non-habit forming
  A smart alternative to conventional drugs

Frequently Asked Questions*

What is the purpose of Colic Calm?

Colic Calm homeopathic medicine provides relief for discomfort from gas, colic, upset stomach, even hiccups and teething in infants.  Importantly, Colic Calm is made according to Good Manufacturing Practices (GMP) for over-the-counter homeopathic medicines.

Is Colic Calm safe for my baby?

Colic Calm is a combination of eight homeopathic remedies, each of which has a long history of safe use. Colic Calm’s proprietary formula is non-habit forming and does NOT contain sugar, sodium bicarbonate, simethicone, herbal oils, soy, dairy, wheat, gluten, animal products, artificial flavors or colors.

What makes Colic Calm different from other colic preparations?

The active ingredients in Colic Calm provide multi-symptom relief to quickly soothe baby’s digestive system. According to the principles of homeopathy, each dose gently stimulates the body’s ability to heal itself, as opposed to merely suppressing symptoms.

How long does Colic Calm take to work?

Most babies experience relief with their first dose of Colic Calm. However, some may take longer before showing noticeable improvement. We
recommend giving Colic Calm up to one week to fully work its wonders. Keep in mind that many babies simply have trouble calming down once the crying cycle has begun, so it is recommended to administer Colic Calm at the first signs of discomfort.

We encourage you to email us at  customercare@coliccalm.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. Do not dispense faster than baby can comfortably swallow.  If needed, repeat once 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 baby spits up Colic Calm?

Some spitting up is normal. One factor is temperature. Some babies’ stomachs are sensitive to cooler liquids, so Colic Calm  at room temperature could be unsettling.  Colic 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. It is best to avoid giving Colic Calm immediately after feeding if baby’s stomach is full, as spit-up may occur from the added pressure.

Can my baby take other medications while using Colic 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 baby 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 Colic Calm, so that the effects of the other medication are not lessened.

Does Colic Calm have any side effects?

There are no known contraindications to any of the active ingredients in Colic 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 Colic Calm uses a form of carbon called Carbo Vegetabilis (vegetable charcoal).  This pure, naturally-derived, non-carcinogenic vegetable charcoal makes Colic 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?

Colic 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 that stain removal doesn’t become an issue.

Can Colic Calm be used for anything other than colic?

Yes. Colic Calm is helpful in easing pain associated with stomach upset. Many toddlers and older children benefit from stomach ache relief with Colic Calm. Colic Calm can also provide relief for flatulence and bloating from gas. In addition, a great number of parents swear by Colic Calm for effective
treatment of hiccups.

How long should each bottle last?

Each bottle contains (47) ¼ teaspoon (1.25 ml) doses for babies under 20 lbs. or (24) ½ teaspoon (2.5 ml) doses for those over 20 lbs. Some children require more doses than others, depending on the frequency of their symptoms. Discard bottle within 8 weeks after opening.

How do I store Colic Calm?

This product should be stored at room temperature, out of direct sunlight. Because there is no need for refrigeration, Colic Calm is also ideal for traveling away from home.

Why does my baby sleep soundly and longer after taking Colic Calm?

Peaceful sleep often follows naturally after relief. There are no narcotic, sedative or habit-forming ingredients in Colic Calm.

What is "colic"?

Colic is defined as inconsolable crying that lasts for more than 3 hours per day for at least 3 days per week. Colic is a self-limiting condition that typically resolves by 3-4 months of age. Most experts point to gastrointestinal
discomfort as the cause, due to the immaturity of a baby’s digestive system:

i. "Intestinal hyperperistalsis is one part of the clinical picture in infantile colic." - Motilin, Vasoactive Intestinal Peptide and Gastrin in Infantile Colic by L. Lothe, M.D., S. A. Ivarsson, M.D., and T. Lindberg, M.D.

ii. "various factors act in tandem, leading to disturbances in infant gastrointestinal motility that manifests clinically as colic." - Is colic a gastrointestinal disorder? by Gupta, Sandeep K., M.D.

iii. "Observation of colicky infants has suggested a gastrointestinal origin for this discomfort." - Efficacy of herbal tea preparation in
infantile colic by Zvi Weizman, M.D., Soliman Alkrinawi, M.D., Dan Goldfarb, M.D., and Chairn Bitran, M.D.

Homeopathy and Dilutions

The homeopathic ingredients in Colic 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. Seven of the eight active ingredients in Colic 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.

Activated Charcoal

Colic 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 Colic Calm is prepared according to HPUS methods. Charcoal has been used safely in medicinal applications for thousands of years.

The activated charcoal in Colic Calm relieves the bloating and abdominal discomfort attributable to gaseousness in colicky babies. Charcoal's efficacy in adsorbing gases and toxins in the digestive system has been established 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, M.D., Patel VP, M.D., Pitchumoni CS, M.D.

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 Colic Calm contains amounts of activated charcoal
corresponding to the amounts used in these efficacy studies, adjusting for the size of the baby.

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 Colic Calm work?

While no product can claim to work for everyone, Colic Calm does have an impressive track record. Visit our website www.coliccalm.com/video/ to view "Seeing is Believing" videos of parents using our products with immediate results. Also, check out hundreds of five star reviews on amazon.com and read "One Mom's Story" customer interviews at journal.coliccalm.com.

Many pediatricians and medical professionals also recommend our products:

"Colic Calm incorporates natural ingredients to reduce colic symptoms … I frequently recommend Colic Calm for my patients because it provides safe, natural relief for symptoms of colic. Our parents’ feedback has been tremendously positive and our patients’ symptoms have improved in almost all instances."
- Steven E. Rahman, M.D., Pediatrician, Lake Worth, Florida

"Colic Calm has really been an excellent treatment for my patients with colic. I have mothers giving me positive feedback on how wonderful Colic Calm has been in relieving colic symptoms in infants of all ages. I even used the product on my own grandson with great results!"
- Roger Mendoza, M.D., Pediatrician, Beaumont, Texas

"Colic Calm had a soothing effect on my baby... I’ve not seen anything so amazing as Colic Calm. What a valuable breakthrough."
- Geneva Lejeune, M.D., Pediatrician, Shreveport, Louisiana

"Excellent product. We used everything…gripe water, gas drops and other homeopathic treatments. This is the ONLY thing that worked for my daughter’s colic."
- Shahreen Hussain-Malik, M.D., Pediatrician, Phoenix, Arizona

We fully stand behind our product with our money-back guarantee, but realize that not every baby will experience relief from Colic Calm. We encourage you to contact our Colic 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 baby simply may not have common “colic”, or the condition may be one that Colic 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.coliccalm.com/refund for full details on our refund policy. Refunds available to US customers only.

Do not use Colic Calm to treat other medical conditions not indicated on the product packaging. Colic 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 colic that may cause a baby 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 baby’s health condition and the use of this or any other medicine.

* These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.
** All active ingredients are derived from natural sources.

Learn More About Colic Calm®

Visit coliccalm.com or contact us directly:

Email customercare@coliccalm.com
Phone (877) 321-CALM

Win $2,500 for Your Home Video
Share a home video of Colic Calm helping your baby and if your video is selected you will receive $2,500. Many will enter, many will win! For easy-to-follow directions visit: coliccalm.com/homevideo

Package Label Display:

HOMEOPATHIC MEDICINE*        NDC: 13992-009-01

Colic Calm®
Homeopathic
Gripe Water

Fast Acting,
Safe & Gentle,
Great Tasting

#1 SELLING MEDICINE

For Symptomatic Relief of Infant
GAS · COLIC · UPSET STOMACH

Money Back Guarantee
24 - 47 Doses Oral Suspension 2 FL. OZ. (59 ML)

INGREDIENTS AND APPEARANCE

COLIC CALM 
carbo vegetabilis, carum carvi, chamomilla, foeniculum vulgare, melissa officinalis, mentha piperita, prunus spinosa, zingiber officinale liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13992-009
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
CARAWAY SEED (UNII: W2FH8O2BBE) (CARAWAY SEED - UNII:W2FH8O2BBE)	CARAWAY SEED	3 [hp_X]  in 1 mL
CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X)	CHAMOMILE	3 [hp_X]  in 1 mL
FENNEL SEED (UNII: G3QC02NIE6) (FENNEL SEED - UNII:G3QC02NIE6)	FENNEL SEED	3 [hp_X]  in 1 mL
MELISSA OFFICINALIS (UNII: YF70189L0N) (MELISSA OFFICINALIS - UNII:YF70189L0N)	MELISSA OFFICINALIS	3 [hp_X]  in 1 mL
MENTHA PIPERITA (UNII: 79M2M2UDA9) (MENTHA PIPERITA - UNII:79M2M2UDA9)	MENTHA PIPERITA	3 [hp_X]  in 1 mL
PRUNUS SPINOSA FLOWER BUD (UNII: 53Y84VPS2W) (PRUNUS SPINOSA FLOWER BUD - UNII:53Y84VPS2W)	PRUNUS SPINOSA FLOWER BUD	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: 13992-009-01	1 in 1 CARTON	03/14/2017
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		03/14/2017

Labeler - TJL Enterprises Inc. (004042785)

Registrant - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture(13992-009) , api manufacture(13992-009) , label(13992-009) , pack(13992-009)