FDA.reportPublic FDA data

Chest Comfort

Manufacturer
Saje Natural Business Inc.
Effective date
2026-01-12
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:33:58

Label at a glance#

ProductChest Comfort
Active ingredientMENTHOL
Label structure19 sections

Storage and handling

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

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Menthol 2.76%

OTC - PURPOSE SECTION

Purpose Antitussive (Cough Suppressant)

Uses Temporarily suppresses cough due to minor throat and bronchial irritation associated with a cold or inhaled irritants. Controls the impulse to cough to help you get to sleep.

WARNINGS SECTION

For external use only.

Do not take by mouth or place in nostrils

Flammable: Keep away from fire or flame.

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

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

INACTIVE INGREDIENT SECTION

Beeswax (yellow), melaleuca alternifolia (tea tree) leaf oil, olibanum, peppermint oil, piper nigrum (pepper) seed oil, rosmarinus officinalis (rosemary) leaf oil, and vitis vinifera (grape) seed oil.

OTC - QUESTIONS SECTION

1-877-275-7253

SPL UNCLASSIFIED SECTION

Distributed by: SAJE NATURAL WELLNESS 22 E. 5th Ave. Vancouver, BC Canada V5T 1G8 | saje.com | @sajewellness | Made by our friends in Canada

SKU 703992

Lift here to continue to read important product information

DISPOSAL AND WASTE HANDLING

Please recycle where possible.

SPL UNCLASSIFIED SECTION

IMPORTANT: READ ALL PRODUCT INFORMATION BEFORE USING. KEEP THIS PACKAGE FOR FULL INFORMATION. DO NOT USE IF SECURITY SEAL IS BROKEN OR MISSING.

DESCRIPTION SECTION

Chest Comfort, net wt 1.91 oz | 54.1 g, antitussive (cough suppressant) balm

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Saje® Natural Wellness

Chest Comfort

Antitussive (Cough Suppressant) Balm

net wt. 1.91 oz | 54.1 g Chest Comfort Final R5Chest Comfort Final R5

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1813426menthol 2.76 % Topical OintmentPSN5
1813426menthol 0.0276 MG/MG Topical OintmentSCD5
1813426menthol 2.76 % Topical OintmentSY5

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70983-001-01Chest Comfort54.1 g in 1 CANISTERSALVE54.15
70983-001-01Chest Comfort1 in 1 BOXSALVE15

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70983-00170983-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
YELLOW WAX2ZA36H0S2VIACT
TEA TREE OILVIF565UC2GIACT
FRANKINCENSE OIL67ZYA5T02KIACT
PEPPERMINT OILAV092KU4JHIACT
BLACK PEPPER OILU17J84S19ZIACT
ROSEMARY OIL8LGU7VM393IACT
GRAPE SEED OIL930MLC8XGGIACT
MENTHOLL7T10EIP3AACTIB

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
Chest ComfortMENTHOLSaje Natural Business Inc.8a3db169-6dd7-4dfd-8360-90315288f21b2026-01-12WarningsExact identifier
ndc (package): 70983-001-01
ndc (product): 70983-001
ndc11 (package): 70983000101
spl id: 48c237b3-ff07-84b2-e063-6394a90ad1da
spl set id: 8a3db169-6dd7-4dfd-8360-90315288f21b

Reported adverse events (FAERS/openFDA)#

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