Label: TUMMY CALM- tribasic calcium phosphate, activated charcoal, chamomile, citrullus colocynthis fruit, lycopodium complanatum whole, moschus moschiferus whole, escherichia coli, silicon dioxide and thuja occidentalis leaf liquid 

  • Label RSS
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 09/13

If you are a consumer or patient please visit this version.

  • Active Ingredients

    Calcarea Phosphorica......12X

    Carbo Vegetabilis.............2X

    Chamomilla.....................12X

    Colocynthis.....................12X

    Lycopodium....................12X

    Moschus..........................12X

    Natrum Muriaticum........12X

    Silicea.............................12X

    Thuja...............................12X

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  • Purpose

    Gas Relief, Teething, Bloating, Upset Stomach, Calming and Soothing, Hiccups, Burping

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  • Uses

    Temporarily relieves the symptoms of:

    • gas
    • bloating
    • upset stomach
    • hiccups
    • teething
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  • 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.
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  • Keep out of reach of children
  • 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 into mouth, between cheek and gums, or mix into drink.
    • If needed, repeat every 30 minutes for up to 3 doses, or as directed by physician. Do not exceed 6 full doses in 24 hours.
    • Recap bottle and clean oral dispenser.
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  • Other Information

    Please note: Sleep may follow naturally after relief.

    Store at room temperature, out of direct sunlight.

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  • Inactive Ingredients

    citric acid, glycerin, potassium benzoate, potassium citrate, purified water, sorbic acid, xylitol

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  • Questions or comments?

    Call (877) 321-CALM

    Visit us at
    www.tummycalm.com

    Or ask your physician, health care practitioner or pharmacist.

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  • Patient Information

    Relief. Pure & Simple.

    Thank you for choosing Tummy Calm® homeopathic medicine, the natural alternative to simethicone for the treatment of gas and so much more. As the makers of Colic Calm®, we have already delivered digestive relief to more than a half million babies. That’s why our products are recommended by pediatricians, natural health care practitioners, and pharmacists.

    Tummy 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 Tummy Calm® and is it safe for my child?

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

    Tummy Calm® is a combination of nine homeopathic remedies, each of which has a long history of safe use. Tummy 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 Tummy Calm® different from simethicone gas drops?

    Instead of relying on only one active ingredient, the many synergistic ingredients in Tummy Calm® work together to provide multi-symptom relief. 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 children experience relief within minutes of their first dose of Tummy Calm®. However, some may take longer before showing noticeable improvement. Sometimes it takes a few days until new positive relief associations can be made with Tummy Calm®.

    We recommend giving Tummy Calm® at least one week to fully work its wonders. We encourage you to email us at customercare@tummycalm.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 symptoms, shake bottle to obtain a uniform dark mixture.

    For infants, 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. 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.

    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 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: Tummy Calm® can be used to prevent or lessen digestive upset that may occur after feeding/meals. To treat excessive gas, many parents report excellent results by administering one quarter to one half the recommended dose before feedings when these usually result in symptoms.

    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 unlikely.

    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 serious 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.

    The only harmless side effect you may notice is a temporary 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. 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.

    Note: A dispensing alternative is the NumiMed Dispenser, also developed by a mother “in need” and available at www.tummycalm.com. For infants, we recommend its purchase along with Tummy 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.

    Can Tummy Calm® be used for anything other than gas?

    Yes. Tummy Calm® is extremely helpful in easing pain associated with the introduction of new foods, and 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 (48) ¼ teaspoon (1.25 mL) doses for infants 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 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 and longer after taking Tummy Calm®?

    Peaceful sleep often follows naturally after relief. There are no narcotic or habit-forming ingredients in Tummy Calm®.

    Learn More About Tummy Calm®

    Visit tummycalm.com or contact us directly:

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

    Try Our Other Products

    Colic Calm® - Effectively relieves colic, gas & upset stomach in newborns & babies.

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

    Tummy Calm®
    Pure Relief.
    Naturally.

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  • Package/Label Principal Display Panel

    Tummy Calm Carton Label

    Carton Label

    Homeopathic Medicine

    NDC 13992-003-01

    Tummy Calm®

    Pure & Natural Gas Relief

    • Safe & Gentle
    • Fast Acting
    • Great Tasting

    Also Relieves:

    • Bloating
    • Upset Stomach
    • Hiccups

     

    For Infants & Children

    The smart alternative to simethicone

    24 - 48 Doses
    Oral Suspension
    2 fl. oz.

    DISTRIBUTED BY

    TJL Enterprises, Inc.

    Long Beach, CA 90803

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  • INGREDIENTS AND APPEARANCE
    TUMMY CALM 
    calcarea phosphorica, carbo vegetabilis, chamomilla, colocynthis, lycopodium, moschus, natrum muriaticum, silicea, thuja liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:13992-003
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    TRIBASIC CALCIUM PHOSPHATE (CALCIUM CATION) CALCIUM CATION 12 [hp_X]  in 59 mL
    ACTIVATED CHARCOAL (ACTIVATED CHARCOAL) ACTIVATED CHARCOAL 2 [hp_X]  in 59 mL
    CHAMOMILE (CHAMOMILE) CHAMOMILE 12 [hp_X]  in 59 mL
    CITRULLUS COLOCYNTHIS FRUIT (CITRULLUS COLOCYNTHIS FRUIT) CITRULLUS COLOCYNTHIS FRUIT 12 [hp_X]  in 59 mL
    LYCOPODIUM COMPLANATUM WHOLE (LYCOPODIUM COMPLANATUM WHOLE) LYCOPODIUM COMPLANATUM WHOLE 12 [hp_X]  in 59 mL
    MOSCHUS MOSCHIFERUS WHOLE (MOSCHUS MOSCHIFERUS WHOLE) MOSCHUS MOSCHIFERUS WHOLE 12 [hp_X]  in 59 mL
    ESCHERICHIA COLI (ESCHERICHIA COLI) ESCHERICHIA COLI 12 [hp_X]  in 59 mL
    SILICON DIOXIDE (SILICON DIOXIDE) SILICON DIOXIDE 12 [hp_X]  in 59 mL
    THUJA OCCIDENTALIS LEAF (THUJA OCCIDENTALIS LEAF) THUJA OCCIDENTALIS LEAF 12 [hp_X]  in 59 mL
    Inactive Ingredients
    Ingredient Name Strength
    CITRIC ACID MONOHYDRATE  
    GLYCERIN  
    POTASSIUM BENZOATE  
    POTASSIUM CITRATE  
    WATER  
    SORBIC ACID  
    XYLITOL  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:13992-003-01 1 in 1 CARTON
    1 59 mL in 1 BOTTLE, WITH APPLICATOR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Unapproved homeopathic 05/25/2012
    Labeler - TJL Enterprises Inc. (004042785)
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