Otc - Active Ingredient
ACTIVE INGREDIENTS (HPUS*) - equal amounts of: Aethusa Cynapium 30X, Alumina 30X, Bryonia Alba 30X, Calcarea Carbonica 30X, Chamomilla 30X, Lycopodium Clavatum 30X, Phosphorus 30X, Pulsatilla 30X, Silicea 30X, Sulphur 30X.
Colic Cp Liquid
FDA Label NDC 43406-0056
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Natural Creations, Inc. for the product Colic Cp (NDC 43406-0056). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, dosage & administration, otc - keep out of reach of children, warnings, inactive ingredient, otc - questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
USES: Temporarily relieves restlessness, crying, irritability, sensitivity, wanting to be carried, poor sleep, &/or other symptoms related to colic.**
Indications & Usage
USES: Temporarily relieves restlessness, crying, irritability, sensitivity, wanting to be carried, poor sleep, &/or other symptoms related to colic.**
Dosage & Administration
DIRECTIONS: 10 drops orally 3 times daily, or as directed by a health care professional.
Otc - Keep Out Of Reach Of Children
KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.
Warnings
WARNINGS:
* IF PREGNANT OR BREAST-FEEDING, ask a health care professional before use.
* KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.
* Do not use if TAMPER EVIDENT seal is broken or missing.
Inactive Ingredient
INACTIVE INGREDIENTS: Citric Acid, Glycerin, Natural Cherry Flavor, Potassium Sorbate, Purified Water.
Otc - Questions
QUESTIONS AND COMMENTS?
Natural Creations, Inc. / Woodbine, IA 51579 / 712-647-1600
References
* The letters "HPUS" indicate the components in the product are officially monographed in the Homeopathic Pharmacopeia of the United States.
** These statements have not been reviewed by the FDA. They are based on traditional homeopathic practice.
LOT:
Package Label.Principal Display Panel
NDC: 43406-0056-1
COLIC CP
Colic**
HOMEOPATHIC
1 fl oz (30 mL) / 20% Alcohol
GMP Logo UPC: 877730000989 NON GMO Logo
* Please review the disclaimer below.
