Cough Syrup
FDA Label NDC 43406-0664

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 Cough Syrup (NDC 43406-0664). 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, indications & usage, otc - purpose, 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 - Active Ingredient

ACTIVE INGREDIENTS (HPUS*): Camphora 3X, 30C, Arsenicum Album 30C, Bryonia Alba 30C, Drosera Rotundifolia 30C, Ipecacuanha 30C, Kali Carbonicum 30C, Phosphorus 30C, Pulsatilla 30C, Spongia Tosta 30C, Squilla Maritima 30C.

Indications & Usage

USES: Temporarily relieves dry cough, dry barking cough, dry, hacking, painful cough, incessant coughing, dry rattling cough, congestion and tightness of chest, shortness of breath, and/or other symptoms related to coughing.**

Otc - Purpose

USES: Temporarily relieves dry cough, dry barking cough, dry, hacking, painful cough, incessant coughing, dry rattling cough, congestion and tightness of chest, shortness of breath, and/or other symptoms related to coughing.**

Dosage & Administration

DIRECTIONS: Adults & children above 4 years: 1 teaspoon (5mL) every 2-3 hours, or as directed by a health care professional. Shake well before use.

Otc - Keep Out Of Reach Of Children

KEEP OUT OF THE REACH OF CHILDREN. In case ov overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.

Warnings

WARNINGS:

  • Consult a physician for use in children under 12 years of age.
  • IF PREGNANT OR BREAST-FEEDING, ask a health 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: Acacia Gum, Anise Oil, Citric Acid, Eucalyptus Oil, Glycerin, Herbal Base [Chamomile (flower), Echinacea Angustifolia (Flower), Iceland Moss (Herb), Marshmallow (Root), Mullein (Leaf), Plantain (Leaf), Red Clover (Flower), Stinging Nettle (Leaf), Thyme (Herb)], Honey, Natural Cherry Flavor, Natural Mixed Berry Flavor, Potassium Sorbate, Purified Water.

Otc - Questions

QUESTIONS & COMMENTS?

Natural Creations, Inc. / Woodbine, IA 51579 / 712-647-1600

References

*The letters "HPUS" indicate the components in this 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.

Package Label.Principal Display Panel

NDC: 43406-0664-4

COUGH SYRUP

HOMEOPATHIC

Natural Cherry / Mixed Berry Flavor

4 fl oz (120 mL)

* Please review the disclaimer below.