FDA Label for Complete Fortify

View Indications, Usage & Precautions

Complete Fortify Product Label

The following document was submitted to the FDA by the labeler of this product Saje Natural Business Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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GET READY FOR WELLNESS

TAKE THE PLANT-BASED COMPLETE FORTIFY CONVENIENCE KIT WITH YOU WHEN YOU ARE TRAVELLING OR ON-THE-GO

KIT CONTAINS 3 FORTIFYING FAVORITES:

FORTIFY antitussive (cough suppressant) oil blend rub

echinacea HERBAL SPRAY SUPPLEMENT

fortified warmth RESTORATIVE BATH SALTS SOAK

IMPORTANT: FOR EACH PRODUCT, READ ALL PRODUCT INFORMATION ON OUTER AND INNER BOX FLAP BEFORE USING.  KEEP THIS PACKAGE FOR FULL INFORMATION.

Distributed by: SAJE NATURAL WELLNESS | 500-88 E. Pender St. Vancouver, BC Canada, V6A 3X3 | saje.com | 1-877-275-7253 | Made by our friends in Canada

LIFT HERE TO CONTINUE TO READ IMPORTANT PRODUCT INFORMATION ON OUTER AND INNER BOX FLAP BEFORE USING.  KEEP THIS PACKAGE FOR FULL INFORMATION.

DO NOT USE IF ANY OF THE FOLLOWING SECURITY FEATURES ARE BROKEN OR MISSING: SEAL AROUND BOTTLE (OIL BLEND) | SEAL AROUND BOTTE'S CAP AND NECK (SPRAY) | TEAR NOTCH ON ZIPPERED BAG INSIDE (SALTS)

We support recycling. Please recycle where possible.

SKU 22250801


Fortify Antitussive (Cough Suppressant) Oil Blend Rub Drug Factsactive Ingredient



Menthol 2.7%


Otc - 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.


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. 


Do Not Use



  • if epileptic
  • with high blood pressure

Ask 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 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

Dosage & Administration



  • 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. 


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.


Fortified Warmth Restorative Bath Salt Soak



DIRECTIONS FOR USE: FOR A STRENGTHENING AND FORTIFYING BATH, ADD 2 TEASPOONS TO WATER & SWISH TO DISSOLVE. CLOSE THE DOOR TO KEEP THE PRECIOUS AROMAS IN & STAY IMMERSED FOR 20-30 MINUTES.  FOR PROLONGED USE, CONSULT A DOCTOR

INGREDIENTS: SEA SALT, MAGNESIUM SULFATE, ZEA MAYS (CORN) STARCH, SODIUM BICARBONATE, MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL, PINUS SYLVESTRIS LEAF OIL, ROSMARINUS OFFICINALIS (ROSEMARY) LEAF OIL, PELARGONIUM GRAVEOLENS OIL, EUCALYPTUS GLOBULUS LEAF OIL, MENTHA PIPERITA (PEPPERMINT) OIL, AND CINNAMOMUM ZEYLANICUM LEAF OIL

WARNINGS: KEEP OUT OF REACH OF CHILDREN.  FOR EXTERNAL USE ONLY.  IF SWALLOWED, SEEK URGENT CARE OR CALL POISON CONTROL.  AVOID EYES & MUCOUS MEMBRANES;  IF CONTACT OCCURS, RINSE WITH VEGETABLE OIL.  DO NOT USE IF PREGNANT/BREASTFEEDING OR IF EPILEPTIC.  IF ALLERGIC REACTION OCCURS, STOP USE & CONSULT A DOCTOR


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


* Please review the disclaimer below.