OTC Medication Information: Fortify

FORTIFY- menthol oil
Saje Natural Business Inc.

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


DRUG FACTS Active ingredient

Menthol 2.7%

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

For external use only.

Do not take by mouth or place in nostrils

Flammable: Keep away from fire or flame.

Do not use

  • if epileptic
  • with high blood pressure

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).

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.

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.

If pregnant or breast-feeding,

do not use this product.

Keep out of reach of children.

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

Directions

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

Other information

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

Inactive ingredients

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?

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

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

Fortify 30 ml

SKU 332001

Fortify 10 ml

SKU 431301

Fortify 6 ml

SKU 439901

Please recycle where possible.

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

Saje® Natural Wellness

Fortify

Antitussive (Cough Suppressant) Oil Blend Rub

1 fl. oz. | 30 ml

- Fortify 30 ml R3
(click image for full-size original)

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

Saje® Natural Wellness

Fortify

Antitussive (Cough Suppressant) Oil Blend Rub

0.34 fl. oz. | 10 ml

- Fortify 10 ml V4
(click image for full-size original)

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

Saje® Natural Wellness

Fortify

Antitussive (Cough Suppressant) Oil Blend Rub

0.2 fl. oz. | 6 ml

- Fortify 6 ml R3
(click image for full-size original)
FORTIFY
menthol oil
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:70983-002
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL (MENTHOL) MENTHOL 24 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
CINNAMON OIL
EUCALYPTUS OIL
TEA TREE OIL
PELARGONIUM GRAVEOLENS FLOWER OIL
PEPPERMINT OIL
PINE NEEDLE OIL (PINUS SYLVESTRIS)
ROSEMARY OIL
GRAPE SEED OIL
Product Characteristics
Color white (clear) Score
Shape FREEFORM (oil) Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70983-002-03 1 BOTTLE, DROPPER in 1 BOX contains a BOTTLE, DROPPER
1 30 mL in 1 BOTTLE, DROPPER This package is contained within the BOX (70983-002-03)
2 NDC:70983-002-04 1 BOTTLE, DROPPER in 1 BOX contains a BOTTLE, DROPPER
2 10 mL in 1 BOTTLE, DROPPER This package is contained within the BOX (70983-002-04)
3 NDC:70983-002-05 1 BOTTLE, DROPPER in 1 BOX contains a BOTTLE, DROPPER
3 6 mL in 1 BOTTLE, DROPPER This package is contained within the BOX (70983-002-05)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M012 10/16/2016
Labeler — Saje Natural Business Inc. (080465432)
Establishment
Name Address ID/FEI Operations
Natures Formulae Health Products Ltd. 241385587 manufacture (70983-002)

Revised: 10/2023 Saje Natural Business Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2024. All Rights Reserved.