Organix Complete
FDA Label NDC 61941-0132

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Prophase Labs, Inc. for the product Organix Complete (NDC 61941-0132). 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 other, otc - purpose, uses, sore throat warning, otc - ask doctor, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Otc - Purpose

Active ingredients (in each drop)Purposes
Menthol 2.5mgcough suppressant, oral anesthetic
Pectin 1.7mgoral demulcent

Uses

temporarily relieves:

  • cough associated with a cold or inhaled irritants
  • occasional minor irritation, pain, sore mouth and sore throat

Sore Throat Warning

if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. Do not give to children under 5 years of age unless directed by a doctor.

Otc - Ask Doctor

Ask a doctor before use if you have:

  • persistent or chronic cough such as occurs with smoking, asthma or emphysema
  • cough accompanied by excessive phlegm (mucus)

Otc - Stop Use

Stop use and ask a doctor if:

  • cough lasts more than 1 week, tends to reoccur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
  • sore mouth does not improve in 7 days
  • irritation, pain or redness persists or worsens

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Directions

  • adults and children 5 years and older: Dissolve 2 drops (one at a time) slowly in the mouth. Repeat every 2 hours as needed.
  • children under 5 years: ask a doctor

Other Information

  • store in a cool dry place after opening

Inactive Ingredients

natural flavors, organic caramel color, organic evaporated cane juice, organic hyssop, organic marshmallow root, organic mullein, organic peppermint oil, organic sage, organic slippery elm, organic sunflower oil, organic tapioca syrup, organic thyme, sucrose

Questions? Comments?

Call 1-800-505-2653 9am-5pm Eastern

Principal Display Panel - 21 Drop Package

Multi Symptom Relief

ORganix™
COMPLETE

Cough & Sore Throat Drops

Menthol (from Peppermint Oil) - Cough Suppressant
Pectin - Oral Demulcent

Mint Chocolate
Flavor

MADE WITH
70% ORGANIC
INGREDIENTS

Suppresses Coughs

Soothes Sore Throats

Blend of 6 Organic Herbs

Gluten Free

21 Drops

Principal Display Panel (21 Drop Package)

Principal Display Panel (21 Drop Package)

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