SINULIEF- loratadine tablet

SinuLief by

Drug Labeling and Warnings

SinuLief by is a Otc medication manufactured, distributed, or labeled by RoseWell Pharmaceuticals LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient (in each tablet)

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

WARNINGS

Do not use

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

Ask a doctor before use if you have

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

When using this product

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

Stop use and ask a doctor

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

I pregnant or breast-feeding

ask a health professional before use.

Keep out of reach of children

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

WHEN USING

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

Other 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

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

Questions and Comments?

Call 1-833-999-7795

PURPOSE

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

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

Package Label.Principal Display Panel

INGREDIENTS AND APPEARANCE

SINULIEF 
loratadine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85510-101
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN)	LORATADINE	10 mg

Inactive Ingredients
Ingredient Name	Strength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	6mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85510-101-01	10 in 1 BLISTER PACK; Type 0: Not a Combination Product	04/18/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	04/18/2025

Labeler - RoseWell Pharmaceuticals LLC (119358987)