Fortify

Manufacturer
Saje Natural Business Inc. | Natures Formulae Health Products Ltd.
Effective date
2026-01-13
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:32:51

Label at a glance#

ProductFortify
Active ingredientMENTHOL
Label structure23 sections

Dosage and administration

See important warnings under 'When using this product'. Adults and children 12 years of age and older: rub on the throat and chest in a thick layer cover with a warm, dry cloth if desired clothing should be loose about throat and chest to help vapors reach the nose and mouth

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

IMPORTANT: READ ALL PRODUCT INFORMATION BEFORE USING. KEEP THIS PACKAGE FOR FULL INFORMATION.

DRUG FACTS Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 2.7%

OTC - PURPOSE SECTION

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.

Warnings

WARNINGS SECTION

For external use only.

Do not take by mouth or place in nostrils

Flammable: Keep away from fire or flame.

Do not use

OTC - DO NOT USE SECTION

  • if epileptic 
  • with high blood pressure

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

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

When using this product, do not

OTC - WHEN USING SECTION

  • heat
  • microwave
  • use near an open flame
  • add to hot water or any container where heating water.  May cause splattering and result in burns.

Stop use and ask a doctor if

OTC - STOP USE SECTION

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. 

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

do not use this product.

Keep out of reach of children. 

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

INDICATIONS & USAGE SECTION

  • See important warnings under 'When using this product'.
  • Adults and children 12 years of age and older: rub on the throat and chest in a thick layer
  • cover with a warm, dry cloth if desired
  • clothing should be loose about throat and chest to help vapors reach the nose and mouth

DOSAGE & ADMINISTRATION SECTION

  • use up to three times daily or as directed by a doctor.
  • Children under 12 years of age: ask a doctor. 

Other information

OTHER SAFETY INFORMATION

  • Close container tightly and store at room temperature away from heat

Inactive ingredients

INACTIVE INGREDIENT SECTION

Cinnamon oil, eucalyptus oil, melaleuca alternifolia (tea tree) leaf oil, pelargonium graveolens oil, peppermint oil, pine needle oil, rosmarinus officinalis (rosemary) leaf oil, and vitis vinifera (grape) seed oil. 

Questions?

OTC - QUESTIONS SECTION

1-877-275-7253

Distributed by: SAJE NATURAL WELLNESS 22 East 5th Ave. Vancouver, BC Canada V5T 1G8 | saje.com | @sajewellness | 1-877-275-7253 | Made in Canada

SPL UNCLASSIFIED SECTION

Do not use if security seal around bottle is broken or missing.

Fortify 30 ml

SPL UNCLASSIFIED SECTION

SKU 332001

Fortify 10 ml

SPL UNCLASSIFIED SECTION

SKU 431301

Fortify 6 ml

SPL UNCLASSIFIED SECTION

SKU 439901

DISPOSAL AND WASTE HANDLING

Please recycle where possible.

Fortify Antitussive (Cough Suppressant) Oil Blend Rub - 30 ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Saje® Natural Wellness

Fortify

Antitussive (Cough Suppressant) Oil Blend Rub

1 fl. oz. | 30 ml

- Fortify 30 ml R3- Fortify 30 ml R3

Fortify Antitussive (Cough Suppressant) Oil Blend Rub - 10 ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Saje® Natural Wellness

Fortify

Antitussive (Cough Suppressant) Oil Blend Rub

0.34 fl. oz. | 10 ml - Fortify 10 ml V4- Fortify 10 ml V4

Fortify Antitussive (Cough Suppressant) Oil Blend Rub - 6 ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Saje® Natural Wellness

Fortify

Antitussive (Cough Suppressant) Oil Blend Rub

0.2 fl. oz. | 6 ml

- Fortify 6 ml R3- Fortify 6 ml R3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70983-002-03Fortify30 mL in 1 BOTTLE, DROPPEROIL305
70983-002-03Fortify1 in 1 BOXOIL15
70983-002-04Fortify1 in 1 BOXOIL15
70983-002-04Fortify10 mL in 1 BOTTLE, DROPPEROIL105
70983-002-05Fortify1 in 1 BOXOIL15
70983-002-05Fortify6 mL in 1 BOTTLE, DROPPEROIL65

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70983-00270983-002-03, 70983-002-04, 70983-002-05

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FortifyMENTHOLSaje Natural Business Inc.0320a305-99d1-4909-94cc-cd6509ecb9482026-01-13WarningsExact identifier
ndc (package): 70983-002-03
ndc (package): 70983-002-04
ndc (package): 70983-002-05
ndc (product): 70983-002
ndc11 (package): 70983000203
ndc11 (package): 70983000205
ndc11 (package): 70983000204
spl id: 4850561f-988a-f1a7-e063-6394a90a982b
spl set id: 0320a305-99d1-4909-94cc-cd6509ecb948

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.