FDA.reportPublic FDA data

Sine-Aid Peak Misery Nasal Spray

Manufacturer
Infirst Healthcare Inc.
Effective date
2026-08-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-08-11 01:01:45

Label at a glance#

ProductSine Aid PEAK MISERY
Active ingredientOXYMETAZOLINE HYDROCHLORIDE
Label structure11 sections

Label contents#

Full prescribing information#

Drug Facts

SPL UNCLASSIFIED SECTION

.

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Oxymetazoline hydrochloride 0.05%

OTC - PURPOSE SECTION

Purpose

Nasal Decongestant

INDICATIONS & USAGE SECTION

Uses • temporarily relieves nasal congestoin

  • reduces swelling of nasal passages
  • helps decongest sinus openings and passages
  • temporarily relives sinus congestion and pressure
  • promotes sinus drainage
  • shrinks swollen nasal membranes so you can temporarily breathe more freely.

WARNINGS SECTION

Warnings

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

• heart disease • high blood pressure • thyroid disease

• diabetes • trouble urinating due to an enlarged prostate gland

OTC - WHEN USING SECTION

When using this product

• do not exceed recommendeddosage

• do not user for more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen.

• temporary discomfort such as burning, stinging, sneezing or an increase in nasal discharge may occur

• use of this container by more than one person may spread infection.

OTC - STOP USE SECTION

Stop use and ask a doctor if symptoms persist.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

DOSAGE & ADMINISTRATION SECTION

Directions

• adults and children 6 to under 12 years of age (with adult supervision): 2 or 3 sprays in each nostril not more often thanevery 10 to 12 hours. Do not exceed 2 doses in any 24-hour period.

• children under 6 years of age: ask a doctor.

To Use: Shake well before use. Push down cap while turning counter-clockwise and remove cap. Remove clip under rim. Before using the first time, prime metered pump by depressing pump firmly several times. To spray, hold bottle with thumb at base and nozzle rim between first and second fingers. Without tilting head, insert nozzle into nostril. Fully depress rim with a firm, even stroke, and sniff deeply. Wipe nozzle clean after use. Replace clip under rim and secure cap after use.

Other information

SPL UNCLASSIFIED SECTION

• store between 20° to 25°C (68° and 77°F)

• retain carton for future reference on full labeling.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Benzalkonium Chloride, Benzyl Alcohol, Edetate Disodium, Glycerin, Microcrystalline Cellulose, Carboxymethyl Cellulose Sodium, Polyethylene Glycol, Povidone, Purified Water, Sodium Phosphate Dibasic, Sodium Phosphate Monobasic, Xanthan Gum

OTC - QUESTIONS SECTION

Questions? 1-844-451-1653

SPL UNCLASSIFIED SECTION

DO NOT USE IF PRINTED SEAL OVER CAP IS TORN OR MISSING

IMPORTANT: KEEP THIS CARTON FOR FUTURE REFERENCE ON FULL LABELING

infirst +

HEALTHCARE

Manufactured for: Infirst Healthcare Inc.

Westport, CT 06880

@2026 Infirst Healthcare Inc.

www.Sine-AidRelief.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NO-DRIP

Sine-Aid

PEAK

MISERY

Nasal Spray

Oxymetazoline HCl 0.05%

Nasal Decongestant

Fast Relief of Sinus Congestino & Pressure

Clears Sinus Passages

ALL-DAY

or ALL-NIGHT

12-HOUR

RELIEF

1 FL OZ (30mL)

labellabel

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62372-10062372-100-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
OXYMETAZOLINE HYDROCHLORIDEK89MJ0S5VYACTIB
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
BENZYL ALCOHOLLKG8494WBHIACT
EDETATE DISODIUM7FLD91C86KIACT
GLYCERINPDC6A3C0OXIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POVIDONEFZ989GH94EIACT
WATER059QF0KO0RIACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FIACT
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUSKH7I04HPUUIACT
XANTHAN GUMTTV12P4NEEIACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT

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
Sine Aid PEAK MISERYOXYMETAZOLINE HYDROCHLORIDEInfirst Healthcare Inc.586a2a14-7048-0c8b-e063-6394a90a65b72026-08-06WarningsExact identifier
ndc (package): 62372-100-30
ndc (product): 62372-100
ndc11 (package): 62372010030
spl id: 586a2a14-7049-0c8b-e063-6394a90a65b7
spl set id: 586a2a14-7048-0c8b-e063-6394a90a65b7

Reported adverse events (FAERS/openFDA)#

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