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  5. Label Information: Tummy Calm

FDA Label for Tummy Calm

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS:
    2. PURPOSE:
    3. WARNINGS:
    4. KEEP OUT OF REACH OF CHILDREN:
    5. DIRECTIONS:
    6. INDICATIONS:
    7. OTHER INFORMATION:
    8. INACTIVE INGREDIENTS:
    9. QUESTIONS:
    10. PACKAGE LABEL DISPLAY:

Tummy Calm Product Label

The following document was submitted to the FDA by the labeler of this product Calmco Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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


* Please review the disclaimer below.