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| Product NDC Code | 70983-018 | ||||
|---|---|---|---|---|---|
| Drug Name | Complete fortify |
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| Type | Brand | ||||
| Dosage Form | KIT | ||||
| Application Number | M012 | ||||
| Labeler Name | Saje Natural Business Inc. | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.FORTIFY antitussive (cough suppressant) oil blend rub Drug Facts Active ingredient Menthol 2.7%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.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.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.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
Purpose
Information about the drug product’s indications for use.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.
Spl product data elements
Usually a list of ingredients in a drug product.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
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.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
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.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
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
SAJE IS COMMITTED TO PROVIDING 100% NATURAL PRODUCTS, CONTAINING PURE ESSENTIAL OILS AND INGREDIENTS DERIVED FROM MINERAL AND BOTANICAL SOURCES. SAJE PRODUCTS ARE NOT TESTED ON ANIMALS AND DO NOT CONTAIN ANY ARTIFICIAL OR SYNTHETIC CHEMICALS, PRESERVATIVES, FRAGRANCES OR COLORS.
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.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).
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use if epileptic with high blood pressure
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information Close container tightly and store at room temperature away from heat .
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.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.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.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.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, do not use this product.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API