Flu Relief
FDA Label NDC 47242-0021

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 Flu Relief (NDC 47242-0021). 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
Aconitum napellus 30C, HPUSRelieves fever
Anas barbariae 30C, HPUSRelieves fever and chills
Arsenicum album 30C, HPUSRelieves fever and chills
Belladonna 30C, HPUSRelieves pain and headache
Bryonia 30C, HPUSRelieves body aches
Gelsemium sempervirens 30C, HPUSRelieves fever, chills and weakness
Nux vomica 30C, HPUSRelieves sneezing and chills
Pulsatilla 30C, HPUSRelieves chills due to fever

"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: Nasal decongestant; antiussive; analgesic/antipyretic.

Uses

For the relief of the symptoms of the flu, such as sinus congestion, runny nose, deep coughing, headache, body aches, chills and fever.

Warnings

  • Do not use if outer package seal is broken.
  • Stop use and consult a doctor if pain gets worse or lasts more than 10 days, fever gets worse or lasts more than 3 days, you have difficulty swallowing, redness or swelling is present in the painful area, or any new symptoms appear.
  • 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 one tablet thoroughly, allowing it to dissolve in the mouth, then swallow. Repeat every 4 hours as needed.

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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