Complete Fortify
Menthol
Natures Formulae Health Products Ltd.
Human Otc Drug
NDC 69204-019Complete Fortify also known as Menthol is a human otc drug labeled by 'Natures Formulae Health Products Ltd.'. National Drug Code (NDC) number for Complete Fortify is 69204-019. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Complete Fortify drug includes . The currest status of Complete Fortify drug is Active.
Drug Information:
| Drug NDC: | 69204-019 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Complete Fortify |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Menthol |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Natures Formulae Health Products Ltd. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Kit |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | |
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | |
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | OTC MONOGRAPH FINAL |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 01 Jan, 2017 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 11 Jun, 2026 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | part341 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Natures Formulae Health Products Ltd.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | |
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 69204-019-20 | 1 KIT in 1 KIT (69204-019-20) * 30 mL in 1 BOTTLE, SPRAY * 120 g in 1 POUCH * 6 mL in 1 BOTTLE, DROPPER | 01 Jan, 2017 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Purpose antitussive (cough suppressant) uses temporarily calms cough due to minor throat and bronchial irritation associated with a cold or inhaled irritants. relieves the impulse to cough to help you rest.
Product Elements:
Complete fortify menthol fortify menthol cinnamon oil eucalyptus oil tea tree oil pelargonium graveolens flower oil peppermint oil pine needle oil (pinus sylvestris) rosemary oil grape seed oil menthol menthol clear oil echinacea herbal spray supplement water alcohol echinacea purpurea flowering top echinacea purpurea flowering top licorice licorice echinacea angustifolia root echinacea angustifolia root inula helenium root inula helenium root usnea barbata usnea barbata azadirachta indica leaf azadirachta indica leaf zanthoxylum clava-herculis whole zanthoxylum clava-herculis bark fortified warmth sea salt magnesium sulfate, unspecified form starch, corn sodium bicarbonate tea tree oil pine needle oil (pinus sylvestris) rosemary oil pelargonium graveolens flower oil eucalyptus oil peppermint oil cinnamon oil
Indications and Usage:
Directions see important warnings under 'when using this product' adults and children 12 years or older: rub on throat and chest in a thick layer cover with warm cloth if desired clothing should be loose about throat and chest to help vapors reach the nose and mouth
Warnings:
Warnings for external use only. do not that by mouth or place in nostrils. flammable . keep away from fire or flame
Warnings: keep out of reach of children. not recommended for children under 12. consult a doctor before use: with medications or bleeding or bleeding disorders if symptoms persist/worsen do not use: while trying to conceive, or while pregnant/breastfeeding. while taking insulin, oral diabetic medications, ginseng, or other medications / herbs that may lower blood sugar with tuberculosis, leukosis, collagenosis, ms, hiv/aids, autoimmune disorders, or other progressing systemic diseases if taking medications that may aggravate electorlyte imbalance, including diuretics, cardiac glycosides, and corticosteroids with hypertonia (muscular rigitdity, tension, and spasms), hyperkalemia (excessive potassium in the blood) high blood pressure, heart disorders, or severe obesity with kidney, liver, or bile flow disorders. may cause liver or kidney damage; discuss side effects with your doctor if allergic to plants of the asteraceaecompositae/daisy family. stop use if allergic reaction occurs conta
Read more...ins naturally occuring glycyrrhizin from licorice root. overconsumption of glycyrrhizin from licorice root can cause body's potassium levels to fall, possibly resulting in abnormal heart rhythms/high blood pressure/edema (swelling)/lethargy/congestive heart failure.
Do Not Use:
Warnings for external use only. do not that by mouth or place in nostrils. flammable . keep away from fire or flame
Warnings: keep out of reach of children. not recommended for children under 12. consult a doctor before use: with medications or bleeding or bleeding disorders if symptoms persist/worsen do not use: while trying to conceive, or while pregnant/breastfeeding. while taking insulin, oral diabetic medications, ginseng, or other medications / herbs that may lower blood sugar with tuberculosis, leukosis, collagenosis, ms, hiv/aids, autoimmune disorders, or other progressing systemic diseases if taking medications that may aggravate electorlyte imbalance, including diuretics, cardiac glycosides, and corticosteroids with hypertonia (muscular rigitdity, tension, and spasms), hyperkalemia (excessive potassium in the blood) high blood pressure, heart disorders, or severe obesity with kidney, liver, or bile flow disorders. may cause liver or kidney damage; discuss side effects with your doctor if allergic to plants of the asteraceaecompositae/daisy family. stop use if allergic reaction occurs contains naturally occuring glycyrrhizin from licorice root. overconsumption of glycyrrhizin from licorice root can cause body's potassium levels to fall, possibly resulting in abnormal heart rhythms/high blood pressure/edema (swelling)/lethargy/congestive heart failure.
When Using:
When using this product, do not heat microwave use near an open flame add to hot water or any container where heating water. may cause splattering and result in burns.
Dosage and Administration:
Use up to three times daily or as directed by a doctor children under 12 years of age: ask a doctor.
Herbal spray supplement & fortifying bath salts echinacea herbal spray supplement supplement facts serving size 7 sprays (0.03 fl. oz. | 0.98 ml) servings per container 30 ---- amount per serving fresh echinacea purpurea (flower) 427 mg licorice (root) 70 mg fresh echinacea angustifolia (root) 14 mg elecampane (root) 14 mg usnea (lichen) 14 mg neem (leaf) 3.5 mg southern prickly ash (bark) 3.5 mg --- daily value (dv) not established other ingredients: purified water, ethanol (45-50%) directions for use: shake well before use. take 7 sprays by mouth every 2 hours, 6 times per day. consult a health care practitioner for use beyond 4-6 weeks.
Stop Use:
Stop use and ask a doctor if cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. a persistent cough may be a sign of a serious condition.
Package Label Principal Display Panel:
Saje® natural wellness complete fortify restorative convenience kit 1 antitussive (cough suppressant) oil blend rub 0.2 fl. oz. | 6 ml 1 herbal supplement spray 1 fl. oz. | 30 ml 1 bath salts envelope net wt. 4.2 oz. | 120 g complete fortify box