Colic Drops Liquid
FDA Label NDC 63083-2155

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Professional Complementary Health Formulas for the product Colic Drops (NDC 63083-2155). 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 active ingredients, questions, indications, otc - purpose, warnings, otc - keep out of reach of children, otc - pregnancy or breast feeding, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredients

Bryonia 4X
Lycopodium clavatum 4X
Nux vomica 4X
Colocynthis 6X
Alumina 12X
Mercurius corrosivus 12X
Plumbum aceticum 12X
Sulphur 12X
Lachesis mutus 30X
Rhamnus purshiana 30X
Senna 30X

Questions

Professional Formulas

PO Box 2034 Lake Oswego, OR 97035

Indications

For temporary relief of irritability or abdominal tenderness, minor pain, or cramping.*

Otc - Purpose

*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Warnings

Consult a doctor if condition worsens or if symptoms persist. Keep out of the reach of children. In case of overdose, get medical help or contact a poison control center right away. If pregnant or breastfeeding, ask a healthcare professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of the reach of children.

Otc - Pregnancy Or Breast Feeding

If pregnant or breastfeeding, ask a healthcare professional before use.

Directions

Place drops under tongue 30 minutes before/after meals. Adults and children 12 years and over: Take 10 drops up to 3 times per day. Consult a physician for use in children under 12 years of age.

Other Information

Tamper resistant. If seal is broken, do not use. After opening, close container tightly and store at room temperature away from heat.

Inactive Ingredients

10% ethanol, purified water, 8% vegetable glycerin (from soy).

Label

Est 1985

Professional Formulas

Complementary Health

Colic Drops

Homeopathic Remedy

2 FL. OZ. (59 mL)

Label Image (C155 Thumb)

Label Image (C155 Thumb)

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