Colic Calm

TJL Enterprises Inc.

Colic Calm

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredient
• Purpose
• Colic Calm Uses
• Warnings
• Keep out of reach of children
• Directions
• Other Information
• Inactive ingredients
• Questions or comments?
• Patient Information
• Package/Label Principal Display Panel

FULL PRESCRIBING INFORMATION

Active ingredient

Aloe Socotrina......................5X

Carbo Vegetabilis.................1X

Carum Carvi.........................5X

Chamomilla..........................5X

Foeniculum Vulgare.............5X

Melissa Officinalis...............5X

Mentha Piperita....................5X

Prunus Spinosa.....................5X

Zingiber Officinale...............5X

Purpose

Gas Relief, Bloating, Upset Stomach, Digestive Aid, Calming and Soothing, Hiccups, Colic

Colic Calm Uses

Temporarily relieves the symptoms of:

• gas
• colic
• congestion
• upset stomach
• bloating
• hiccups

Warnings

• Do not use if outer seal imprinted with Colic 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 temporarily, harmless, darkening of the stool may occur.
• May stain fabric; protect clothing and furniture.

Keep out of reach of children

Directions

• Shake well before use to obtain uniform dark mixture.
• Remove outer seal imprinted with Colic 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 into mouth, between cheek and gums.
• If needed, repeat every 30 minutes for up to 3 doses, or as directed by a physician. Do not exceed 6 full doses in 24 hours.
• Recap bottle and clean oral dispenser.

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, purified water, sorbic acid, xylitol

Questions or comments?

Call (877) 321-CALM

Visit us at
www.coliccalm

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 helped more than a half million babies…and counting. That’s why it’s recommended by pediatricians, natural health care practitioners, and pharmacists.

Colic Calm® is:

• FDA-regulated medicine
• Safe, gentle & effective
• Non-habit forming or addictive
• A smart alternative to conventional drugs

Frequently Asked Questions

What is the purpose of Colic Calm® and is it safe for my baby?

Colic Calm® homeopathic medicine provides exceptional relief for discomfort from gas, colic, upset stomach, even hiccups and teething. Importantly, all homeopathic medicines must be manufactured using precise pharmaceutical methods and are regulated as over-the-counter medicines, unlike herbals and dietary supplements.

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

What makes Colic Calm® different from other colic preparations?

Instead of relying on only one active ingredient, the many synergistic ingredients in Colic Calm® work together to provide multi-symptom relief and quickly relax baby’s digestive & nervous systems. Each dose gently stimulates the body’s ability to heal itself, as opposed to merely suppressing symptoms.

How long will it take to work?

Most babies experience relief within minutes of their first dose of Colic Calm®. However, some may take longer before showing noticeable improvement, especially infants over one month of age if they have been symptomatic for a while. Sometimes it takes a few days until new positive relief associations can be made with Colic Calm®.

We recommend giving Colic Calm® at least 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 try to administer Colic Calm® at the first signs. We encourage you to email us at customercare@coliccalm.com or please 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 bottle to obtain a uniform dark mixture. We recommend starting with half the indicated dose in the weight chart, gradually increasing over the first few days until the full dose is reached. Fill enclosed oral dispenser and dispense liquid slowly into mouth, between cheek and gums. If needed, repeat every 30 minutes for up to 3 doses, or as directed by a physician. Do not exceed the equivalent of 6 full doses for the appropriate weight category per day. Carefully recap bottle, clean oral dispenser and let air-dry after each use.

Note: Colic Calm® can be given prior to feeding or afterwards…whenever baby is experiencing digestive issues. To treat acid indigestion or excessive gas, many parents report excellent results by administering one quarter to one half the recommended dose before feedings when they know that feedings usually result in symptoms. Try not to give Colic Calm® immediately after feeding if baby’s stomach is full, as spit-up may occur from the added pressure.

What is the best way to administer Colic Calm®?

Babies love the naturally sweet taste of Colic Calm®. Most swallow it easily when the included oral dispenser is placed between the gums and cheek towards the back of the mouth and dispensed slowly.

Note: A dispensing alternative is the NumiMed Dispenser, also developed by a mother “in need” and available at www.coliccalm.com. We recommend its purchase along with Colic Calm®. It is often less messy when baby sucks the sweet, dark formula directly from the pacifier-like NumiMed. Additionally, the NumiMed can be used for any oral medications you are giving your baby.

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.

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 serious 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.

The only harmless side effect you may notice is a temporary darkening of the stool. This occurs because Colic Calm® uses a form of carbon called Carbo Vegetabilis (Vegetable Charcoal). This pure, naturally-produced, 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. That 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 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 extremely helpful in easing pain associated with the introduction of new foods, and the stomach upset that often accompanies teething. 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 (48) 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. We recommend discarding bottle six months 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 or habit-forming ingredients in Colic Calm®.

Learn More About Colic Calm®

Visit coliccalm.com or contact us directly:

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

Try Our Other Products

Tummy Calm® - Effectively relieves gas, bloating & upset stomach in children of all ages.

Gastro Calm® - Quickly and naturally relieves adult heartburn, acid indigestion & sour stomach. Available soon at gastrocalm.com and stores near you.

Colic Calm®
Relief. Pure & Simple.

Package/Label Principal Display Panel

Homeopathic Medicine

NDC 13992-001-01

Colic Calm®

The FIRST Homeopathic Gripe Water

• Great Tasting
• Pure & Natural
• Safe & Gentle
• Fast Acting

Even Helps Hiccups

For Symptomatic Relief of
Gas · Colic · Upset Stomach

24 - 48 Doses
Oral Suspension
2 fl. oz.