FDA.reportPublic FDA data

Sweet Comfort

Manufacturer
Natures Formulae Health Products Ltd.
Effective date
2016-10-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:49:02

Label at a glance#

ProductSweet Comfort
Active ingredientMENTHOL
Label structure20 sections

Dosage and administration

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

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

DRUG FACTS Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 2.76%

OTC - PURPOSE SECTION

Purpose Antitussive (Cough Suppressant)

Uses Temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold or inhaled irritants.  Supresses your cough to help you get to sleep. 

Warnings

WARNINGS SECTION

For external use only.

Do not take by mouth or place in nostrils

Flammable: Keep away from fire or flame.

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).
  • epilepsy

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.
  • sun tan/use tanning beds for 3-4 days after use.

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.

Keep out of reach of children. 

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

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

DOSAGE & ADMINISTRATION SECTION

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

Other information

OTHER SAFETY INFORMATION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Benzoin, lavender oil, lemon oil, melaleuca alternifolia (tea tree) leaf oil, olibanum, pine needle oil, and prunus armeniaca (apricot) kernel oil. 

Questions?

OTC - QUESTIONS SECTION

1-877-275-7253

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

SPL UNCLASSIFIED SECTION

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

Sweet Comfort 10 ml

SPL UNCLASSIFIED SECTION

SKU 431701

Sweet Comfort 6 ml

SPL UNCLASSIFIED SECTION

Lift Here

SKU 432301

DISPOSAL AND WASTE HANDLING

We support recycling. Please recycle where possible.

Sweet Comfort Antitussive (Cough Suppressant) Oil Blend Rub - 10 ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

sweet comfort

Saje® Natural Wellness

Sweet Comfort

Antitussive (Cough Suppressant) Oil Blend Rub

For external use only.

0.34 fl. oz. | 10 ml


Sweet Comfort Box 10 mlSweet Comfort Box 10 ml

Sweet Comfort Antitussive (Cough Suppressant) Oil Blend Rub - 6 ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

sweet comfort

Saje® Natural Wellness

Sweet Comfort

Antitussive (Cough Suppressant) Oil Blend Rub

For external use only.

0.2 fl. oz. | 6 ml

Sweet Comfort Box 10 mlSweet Comfort Box 10 ml

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69204-004SWEET COMFORT (MENTHOL) OIL [NATURES FORMULAE HEALTH PRODUCTS LTD.]1Legacy NDC20181014_781e94d5-1d20-7202-e053-2991aa0ae768.zip

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
69204-00469204-004-04, 69204-004-05

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
STYRAX BENZOIN RESINFE663Z8IROIACT
LAVENDER OILZBP1YXW0H8IACT
LEMON OILI9GRO824LLIACT
TEA TREE OILVIF565UC2GIACT
FRANKINCENSE OIL67ZYA5T02KIACT
PINE NEEDLE OIL (PINUS SYLVESTRIS)5EXL5H740YIACT
APRICOT KERNEL OIL54JB35T06AIACT
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
4651e26f-6a40-c5cb-e063-6294a90aaa16781e94d5-1d20-7202-e053-2991aa0ae7682025-12-19WarningsExact identifier
spl set id: 781e94d5-1d20-7202-e053-2991aa0ae768

Reported adverse events (FAERS/openFDA)#

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