NDC 73282-0005 Tummy Calm

Carbo Vegetabilis, Chamomilla, Lycopodium Clavatum, Nux Moschata, Passiflora Incarnata, Raphanus Sativus, Sarsaparilla (smilax Regelii), Zingiber Officinale

NDC Product Code 73282-0005

NDC CODE: 73282-0005

Proprietary Name: Tummy Calm What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Carbo Vegetabilis, Chamomilla, Lycopodium Clavatum, Nux Moschata, Passiflora Incarnata, Raphanus Sativus, Sarsaparilla (smilax Regelii), Zingiber Officinale What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

NDC 73282-0005-1

Package Description: 1 BOTTLE, WITH APPLICATOR in 1 CARTON > 59 mL in 1 BOTTLE, WITH APPLICATOR

NDC Product Information

Tummy Calm with NDC 73282-0005 is a a human over the counter drug product labeled by Calmco Llc. The generic name of Tummy Calm is carbo vegetabilis, chamomilla, lycopodium clavatum, nux moschata, passiflora incarnata, raphanus sativus, sarsaparilla (smilax regelii), zingiber officinale. The product's dosage form is liquid and is administered via oral form.

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Tummy Calm Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.


Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • 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)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Calmco Llc
Labeler Code: 73282
Marketing Category: UNAPPROVED HOMEOPATHIC - What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 10-27-2021 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Tummy Calm Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

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 • refluxClaims 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      DoseUnder 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 • refluxClaims 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 LLC1215 Sarasota Center Blvd. Sarasota FL 34240Call 941-203-4590 visit www.tummycalm.com

Package Label Display:

Tummy CalmFor symptomatic relief ofGas, Upset Stomach,& RefluxCalmcCo.Homeopathic Medicine2 FL. Oz. (59 mL)24-47 doses

* Please review the disclaimer below.