Cough And Cold Relief
FDA Label NDC 47242-0011

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Homeostasis Laboratories, Inc. for the product Cough And Cold Relief (NDC 47242-0011). 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, uses, warnings, otc - pregnancy or breast feeding, otc - keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active IngredientsPurpose
Allium cepa 30C, HPUSRelieves runny nose
Arsenicum album 30C, HPUSRelieves runny nose
Ferrum phosphoricum 30C, HPUSRelieves loss of energy
Lac caninum 30C, HPUSRelieves throat irritation
Natrum muriaticum 30C, HPUSRelieves sneezing
Nux vomica 30C, HPUSRelieves stuffy nose

"HPUS" indicates that the ingredient is officially included in the Homeopathic Pharmacopeia of the United States and the manufacturer has followed all guidelines set forth.

Statement of Identity: Antitussive.

Uses

Relieves severe cough, runny nose and sneezing due to throat or bronchial irritation associated with the common cold.

Warnings

  • Do not use if outer package seal is broken.
  • A persistent cough may be a sign of a serious condition. If a cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache, stop use and consult a doctor. Do not take this product for persistent or chronic cough such as occurs with smoking, asthma or emphysema, or if cough is accompanied by excessive phlegm (mucus), unless directed by a doctor.
  • Consult a doctor before use in children younger than 8 years of age.

Otc - Pregnancy Or Breast Feeding

  • If pregnant or breast-feeding, consult a health professional before use.

Otc - Keep Out Of Reach Of Children

  • Keep out of reach of children.

Directions

(adults and children 8 years of age and older)

Chew two tablets thoroughly, allowing each to dissolve in the mouth, then swallow. Repeat with one tablet every 4 hours as needed until cold is gone.

Other Information

  • Safe to take with all other medications.
  • Store at 68-77°F (20-25°C) and keep out of direct sunlight.
  • Avoid humid or damp storage conditions. Close well when not in use.

Inactive Ingredients

Lactose, magnesium stearate (vegetable source), stevia leaf extract.

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