Childrens Allergy

Label at a glance#

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-248-449-9300

Websitewww.qualitychoice.comwww.qualitychoice.com

Label contents#

Full prescribing information#

Active ingredient (in each 5 mL teaspoonful)

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:

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

Warnings

WARNINGS SECTION

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 if

OTC - STOP USE SECTION

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

If 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 overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)

Directions

DOSAGE & ADMINISTRATION SECTION

• use only with enclosed dosing cup

age	dose
adults and children 6 years and over	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

SPL UNCLASSIFIED SECTION

• each teaspoonful contains: sodium 1 mg
• store between 20º to 25ºC (68º to 77ºF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

SPL UNCLASSIFIED SECTION

 call 1-248-449-9300- Monday-Friday 9AM-5PM EST

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

**Compare to the active ingredient in Children's Claritin® Allergy

Non-Drowsy*

Children's Allergy

Indoor & Outdoor Allergies

Loratadine Oral Solution 5mg/5mL Anthistamine

24 Hour Relief of:

Running Nose

Sneezing

Itchy, Watery Eyes

Itchy Throat or Nose

ages 2 years & Older

Alcohol-Free

Sugar-Free

Dye-Free Grape flavor

*When taken as directed See Drug Facts panel.

FL OZ (mL)

**This product is not manufactured or distributed by MSD Consumer Care, Inc, distributor of Children's Claritin® Allergy.

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFTEY SEAL AROUND BOTTLE IS BROKEN OR MISSING.

Distributed by C.D.M.A.,Inc.©

43157 W.Nine Mile

Novi, MI 48376-0995

www.qualitychoice.com

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed Socrata Ingredients#

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

• Childrens Allergy Dye Free
• Loratadine
• BUTYLATED HYDROXYANISOLE
• ANHYDROUS CITRIC ACID
• GLYCERIN
• PROPYLENE GLYCOL
• WATER
• SODIUM BENZOATE
• SUCRALOSE

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 5 · 298 matching rows.

Orange Book application contexts#

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Orange Book application contexts page 1 of 1 · 1 matching rows.

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.

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.

Reported adverse events (FAERS/openFDA)#

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