Cold And Flu Relief Liquid
FDA Label NDC 61096-1002

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Eight And Company L.l.c for the product Cold And Flu Relief (NDC 61096-1002). 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, warnings, otc - keep out of reach of children, indications & usage, dosage & administration, other safety information, inactive ingredient, otc - purpose, 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: Allium cepa 30C, Antimonium tartaricum 200C, Arnica montana 3X, Baptisia tinctoria 3X, Eupatorium perfoliatum 200C, Gelsemium sempervirens 200C, Kali bichromicum 200C, Lachesis mutus 200C, Mercurius iodatus ruber 200C, Sticta pulmonaria 200C, Sulphur iodatum 200C, Urtica urens 200C.

Warnings

Warnings: ​If symptoms persist or worsen, seek advice of physician. If pregnant or breast-feeding, ask a health care professional before using. Keep out of reach of children. Contains alcohol, in case of overdose, get medical help or contact a Poison Control Center right away.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Indications & Usage

Temporarily relieves the common symptoms of cold and flu, including:

  • sinus congestion
  • achiness
  • chills
  • headache and fever

Dosage & Administration

  • Adults and children over 12: 2 sprays under the tongue each 30 minutes as needed for symptom relief the first day, 2 sprays 3 times a day thereafter.
  • Ages 2 to 12: 1 spray under the tongue each 30 minutes as needed for the first day, 1 spray 3 times a day thereafter.
  • Under age 2: consult a health care professional.

Other Safety Information

Other Information: Do not use if the transparent seal around spray bottle is broken or missing.

Inactive Ingredient

Inactive Ingredients: Glycerin 10%, v/v, non-GMO organic alcohol 9% v/v, purified water.

Otc - Purpose

Temporarily relieves the common symptoms of cold and flu, including:

° sinus congestion

° achiness

° chills

° headache and fever

° natural

° gluten free

° no artifical flavors or colors

° vegetarian

° no known negative side effects

° no known negative drug interactions

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