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| Product NDC Code | 70983-016 | ||||
|---|---|---|---|---|---|
| Drug Name | Comfort and ease |
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| Type | Brand | ||||
| Dosage Form | KIT | ||||
| Application Number | part341 | ||||
| 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%
SWEET COMFORT antitussive (cough suppressant) oil blend rub Drug Facts Active ingredient Menthol 2.76%
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.
use up to three times daily or as directed by a doctor. Children under 12 years of age: ask a doctor.
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.
Inactive ingredients Benzoin, lavender oil, lemon oil, melaleuca alternifolia (tea tree) leaf oil, olibanum, peppermint oil, pine needle oil, and prunus armeniaca (apricot) kernel 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
Directions See important warnings under 'When using this product' Adults and children 12 years 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
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.
Purpose Antitussive (Cough Suppressant) Uses Temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold or inhaled irritants. Suppresses your cough to help you get to sleep.
Spl product data elements
Usually a list of ingredients in a drug product.Comfort and Ease Menthol Fortify Menthol MENTHOL MENTHOL CINNAMON OIL EUCALYPTUS OIL TEA TREE OIL PELARGONIUM GRAVEOLENS FLOWER OIL PEPPERMINT OIL PINE NEEDLE OIL (PINUS SYLVESTRIS) ROSEMARY OIL GRAPE SEED OIL clear oil Sweet Comfort Menthol MENTHOL MENTHOL STYRAX BENZOIN RESIN LAVENDER OIL LEMON OIL TEA TREE OIL FRANKINCENSE OIL PEPPERMINT OIL PINE NEEDLE OIL (PINUS SYLVESTRIS) APRICOT KERNEL OIL clear oil Inhale GRAPE SEED OIL LAVENDER OIL LEMON OIL PELARGONIUM GRAVEOLENS FLOWER OIL MYRRH OIL PEPPERMINT OIL CHAMAEMELUM NOBILE FLOWER 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.COMFORT & EASE oil blend convenience kit 2 ANTITUSSIVE (COUGH SUPPRESSANT) OIL BLEND RUBS X 0.2 FL. OZ. | 6 mL EA 1 OIL BLEND 0.2 FL. OZ. | 6 mL Saje® Natural Wellness Comfort & Ease 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 Reach for this convenient trio of oil blends to support your wellness, naturally. Kit Contains 3 popular saje oil blends: FORTIFY antitussive (cough suppressant) oil blend rub SWEET COMFORT antitussive (cough suppressant) oil blend rub inhale SOOTHING OIL BLEND FOR DEEP BREATHING 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 ALL OIL BLENDS DO NOT USE IF SECURITY SEAL AROUND BOTTLES IS BROKEN OR MISSING. We support recycling. Please recycle where possible SKU 22250001
Fortify antitussive (cough suppressant) oil blend rub Apply to the following areas, as directed: A - Throat B - Chest
Sweet Comfort antitussive (cough suppressant) oil blend rub Apply to the following areas, as directed: A - Throat B - Chest
SOOTHING OIL BLEND INHALE soothing oil blend for deep breathing Directions for use: Used in aromatherapy to promote peaceful breaths. Apply to forehead and sinus areas, avoiding eyes and mucous membranes. Use on skin to soothe dry areas or add 10-20 drops to a bath. For prolonged use, consult a doctor. Ingredients: Vitis vinifera (grape) seed oil, lavandula angustifolia (lavender) oil, citrus limon (lemon) peel oil, pelargonium graveolens oil, commiphora myrrha oil, mentha piperita (peppermint) oil, and anthemis nobilis flower oil . Warnings: Keep out of reach of children. For external use only. if swallowed, seek urgent care/call poison control. If epileptic, consult a doctor before use. Avoid eyes & mucous membranes; if contact occurs, rinse with vegetable oil. Do not use if pregnant/breastfeeding. If allergic reaction occurs, stop use & consult a doctor. Phototoxic; do not sun tan/use tanning beds for 3-4 days after use. Apply to the following areas: A - Forehead B - Sinus Area
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).
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) epilepsy
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.
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 .
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.
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.
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. sun tan/use tanning beds for 3-4 days after use
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, do not use this product.
If pregnant of 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 For external use only. Do not take by mouth or place in nostrils. Flammable . Keep away from fire or flame.
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