SinuLief

Manufacturer: RoseWell Pharmaceuticals LLC
Effective date: 2025-10-06
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-06-01 01:37:56

Label at a glance#

ProductSinuLief

Active ingredientLORATADINE

Label structure8 sections

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-833-999-7795

Label contents#

Full prescribing information#

Active Ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Loratadine 10 mg.....................................................................................................Antihistamine

Active Ingredient

WARNINGS SECTION

Drug label_only

Do not use

OTC - DO NOT USE SECTION

if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

liver or kidney disease. Your doctor should determine if you need a different dose.

When using this product

OTC - WHEN USING SECTION

do not take more than directed. Taking more than directed may cause drowsiness.

Stop use and ask a doctor

OTC - STOP USE SECTION

if an allergic reaction to this product occurs. Seek medical help right away.

I pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) right away.

OTC - WHEN USING SECTION

Adults and children 6 years and older 1 tablet daily; not more than 1 tablet in 24 hours

Children under 6 years of age ask a doctor

Consumers with liver or kidney disease ask a doctor

DOSAGE & ADMINISTRATION SECTION

Directions

Other information

OTHER SAFETY INFORMATION

store between 20° to 25°C (68°-77° F)
protect from excessive moisture
do not use if blister unit is torn or open
retain carton for complete product information.

Innactive ingredients

INACTIVE INGREDIENT SECTION

lactose monohydrate, magnesium stearate, pregelatinized starch, sodium starch glycolate.

Questions and Comments?

OTC - QUESTIONS SECTION

Call 1-833-999-7795

OTC - PURPOSE SECTION

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

runny nose
itchy, watery eyes
sneezing
itching of the nose or throat

INDICATIONS & USAGE SECTION

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

runny nose
itchy, watery eyes
sneezing
itching of the nose or throat

Uses

Package Label.Principal Display Panel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
311372	loratadine 10 MG 24HR Oral Tablet	PSN	2
311372	loratadine 10 MG Oral Tablet	SCD	2
311372	loratadine 10 MG 24 HR Oral Tablet	SY	2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
85510-101-01	SinuLief	10 in 1 BLISTER PACK	TABLET	10		2

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

SinuLief
Loratadine
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
SODIUM STARCH GLYCOLATE TYPE A CORN

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
85510-101	85510-101-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
LORATADINE	7AJO3BO7QN	ACTIB
SODIUM STARCH GLYCOLATE TYPE A CORN	AG9B65PV6B	IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
1	2025-04-09	full-release	2026-06-01 00:59:30

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SinuLief	LORATADINE	RoseWell Pharmaceuticals LLC	32619143-a782-3497-e063-6394a90aaaec	2025-10-06	Warnings	Exact identifier ndc (package): 85510-101-01 ndc (product): 85510-101 ndc11 (package): 85510010101 spl id: 4084b4ad-91cf-9487-e063-6394a90a3cbe spl set id: 32619143-a782-3497-e063-6394a90aaaec

Reported adverse events (FAERS/openFDA)#

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