NDC 0295-9028 Colic Calm

Carbo Vegetababilis, Carum Carvi, Chamomilla, Foeniculum Vulgare, Melissa Officinalis, Mentha Piperita, Prunus Spinosa, Zingiber Officinale

NDC Product Information

Colic Calm with NDC 0295-9028 is a a human over the counter drug product labeled by Denison Pharmaceuticals, Inc.. The generic name of Colic Calm is carbo vegetababilis, carum carvi, chamomilla, foeniculum vulgare, melissa officinalis, mentha piperita, prunus spinosa, zingiber officinale. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Denison Pharmaceuticals, Inc.

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.

Colic 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.

  • FENNEL SEED 3 [hp_X]/1000mL
  • ACTIVATED CHARCOAL 1 [hp_X]/1000mL
  • CHAMOMILE 3 [hp_X]/1000mL
  • PRUNUS SPINOSA FLOWER BUD 3 [hp_X]/1000mL
  • MENTHA PIPERITA 3 [hp_X]/1000mL
  • GINGER 3 [hp_X]/1000mL
  • CARAWAY SEED 3 [hp_X]/1000mL
  • MELISSA OFFICINALIS 3 [hp_X]/1000mL

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)
  • POTASSIUM CITRATE (UNII: EE90ONI6FF)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • WATER (UNII: 059QF0KO0R)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • XYLITOL (UNII: VCQ006KQ1E)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • BENZOIC ACID (UNII: 8SKN0B0MIM)

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: Denison Pharmaceuticals, Inc.
Labeler Code: 0295
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: 12-18-2020 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: 12-31-2021 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 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Colic 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 Ingredient

Active IngredientsCarbo Vegetabilis 1x, Carum Carvi 3X, Chamomilla 3X, Foeniculum Vulgare 3X, Melissa Officinalis 3X, Mentha Piperita 3x, Prunus Spinosa 3X, Zingiber Officinale 3X

Purpose

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

Uses

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

Warnings

  • Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes:
  • More than 5 doses in 24 hours, which is the maximum daily amount.With other drugs containing acetaminophen.Allergy Alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
  • Skin reddining Blisters RashIf skin reaction occurs, stop use and seek medical help right away. Sore Throat Warning: if sore throat is severe, persists for more than 2 days, or is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Ask A Doctoror Pharmacist Before Use

If your child is taking the blood thinning drug warfarin.

Do Not Use:

Do not use if protective wrap on oral dispenser is broken or missing

When Using This Product,

  • DO NOT EXCEED RECOMMENDED DOSAGE (see overdose warning).

Stop Use And Ask A Doctor If:

  • Symptoms last more than 7 days or inflammation, fever, or infection occursAs with all medications, it is important to ensure that your child's medical professional is aware of the use of this productAs our product is black, a temporary harmless darkening of stool may occurMay stain fabric; take care to protect clothing and furniture

Keep Out Of Reach Of Children.

In case of overdoes, get medical help or contact a Poison Control Center right away.

Directions

  • WeightDoseUnder 20 lbs (9kg)1/4 teaspoon (1.25 ml)Over 20 lbs (9kg)1/2 teaspoon (2.5ml)Remove protective wrap from oral dispenserShake well before useFill enclosed dispenser up to indicated dose level and dispense liquid slowly (drop by drop) into mouth, between cheek and gumsIf needed, repeat every 60 minutes for up to 3 doses. Do not exceed 4 full doses in 24 hoursRecap bottle and clean dispenser after useDiscard remaining product after 3 weeks.

Other Information

  • Please notes: sleep may follow naturally after reliefStore at room temperature, out of direct sunlight

Inactive Ingredients:

Benzoic acid, citric acid (anhydrous), glycerin, potassium citrate, potassium sorbate, purified water, xantural 180, xytilol

Questions?

Call 941-203-4590 visit www.coliccalm.com

* Please review the disclaimer below.