Children's Loratadine Oral Solution

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 5 mL (teaspoonful) (TSP))

OTC - ACTIVE INGREDIENT SECTION

Loratadine 5 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

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

Warnings

WARNINGS SECTION

OTC - DO NOT USE SECTION

Do not use if you have ever had an allergic reaction to this product or any of its ingredients

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.

OTC - WHEN USING SECTION

When using this product do not take more than directed. Taking more than directed may cause drowsiness.

OTC - STOP USE SECTION

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 6 years and older	2 teaspoonfuls (TSP) daily; do not take more than 2 teaspoonfuls (TSP) in 24 hours
children 2 to under 6 years of age	1 teaspoonful (TSP) daily; do not take more than 1 teaspoonful (TSP) in 24 hours
children under 2 years of age	ask a doctor
consumers with liver or kidney disease	ask a doctor

Other information

STORAGE AND HANDLING SECTION

• Each teaspoonful (TSP) contains: sodium 1 mg
• Store between 20° to 25°C (68° to 77°F)

Children's Loratadine Oral Solution is a clear, grape flavored solution supplied in the following oral dosage form:

NDC 0121-0849-10:	10 mL unit dose cup.
NDC 0121-0849-40:	Case contains 40 unit dose cups of 10 mL (0121-0849-10) packaged in 4 trays of 10 unit dose cups each.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Butylated hydroxyanisole, citric acid, glycerin, grape flavor, propylene glycol, purified water, sodium benzoate, sucralose.

Questions

OTC - QUESTIONS SECTION

Call 1-800-845-8210

SPL UNCLASSIFIED SECTION

MANUFACTURED BY
Silarx Pharmaceuticals, Inc.
1033 Stoneleigh Ave
Carmel, NY 10512

PRINCIPAL DISPLAY PANEL - 10 mL Cup Tray Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0121-0849-10

Children's Loratadine
Oral Solution

Dye Free/ Alcohol Free/ Sugar Free

10 mg/ 10 mL

USUAL DOSAGE: See attached Drug Facts

This unit-dose package is not child-resistant.

Store at 20° to 25°C (68° to 77°F)
[See USP Controlled Room Temperature].

10 x 10 mL Unit-Dose Cups

Pharmaceutical
Associates, Inc.
Greenville, SC 29605

T0849100218
R02/18

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

• Childrens Loratadine
• LORATADINE
• ANHYDROUS CITRIC ACID
• BUTYLATED HYDROXYANISOLE
• GLYCERIN
• PROPYLENE GLYCOL
• SODIUM BENZOATE
• SUCRALOSE
• WATER
• POLYSORBATE 80

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Source Document#

Source XML

Orange Book application contexts#

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Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

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Reported adverse events (FAERS/openFDA)#

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