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Childrens Loratadine

Loratadine · Solution

Over-the-counter ANDA Official labelling
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
Childrens Loratadine Sugar Free
Generic name
Loratadine
Dosage form
Solution
Route
Oral
Marketing category
ANDA · ANDA
Labeler
Sun Pharmaceutical Industries, Inc.
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
1
NDC product codes
10
Packages
18
Data completeness
83% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Loratadine 5 mg/5mL 311372 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Solution
Route of administration
Oral
Presentations
28

Regulatory status

Source: Drugs@FDANDC Directory
Application number
076805
Application type
ANDA · Abbreviated New Drug Application
Approval date
August 20, 2004
Sponsor
TARO
Products on application
1
Submissions recorded
7
Products approved under application 076805.
Product Trade name Form Strength Ingredient Status TE Flags
076805-001 LORATADINE SYRUP LORATADINE Over-the-counter —

Approval history

Source: Drugs@FDA
Most recent submissions on application 076805.
Type No. Action Status Date Review
Supplement 20 Labeling Approved August 19, 2014 —
Supplement 19 Labeling Approved August 19, 2014 —
Supplement 25 Manufacturing (CMC) Approved April 21, 2011 —
Supplement 17 Labeling Approved August 31, 2009 —
Supplement 4 Labeling Approved March 3, 2008 —
Supplement 2 Labeling Approved September 19, 2007 —
Original application 1 Approved August 20, 2004 —

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260830). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20260830 HUMAN OTC DRUG · 20260115

Indications and Usage

openFDA Drug Labeling

Uses 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

Purpose

openFDA Drug Labeling

Purpose Antihistamine

Dosage and Administration

openFDA Drug Labeling

Directions • use only with enclosed dosing cup 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

Warnings

openFDA Drug Labeling

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. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Do Not Use

openFDA Drug Labeling

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

Ask a Doctor

openFDA Drug Labeling

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

Stop Use

openFDA Drug Labeling

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

Active Ingredient

openFDA Drug Labeling

Active ingredient (in each 5 mL teaspoonful) Loratadine 5 mg

Adverse event reports

Source: openFDA FAERS
114,194
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: LORATADINE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Recalls

Source: FDA Enforcement
Drug recall enforcement reports associated with this product.
Classification Reported Firm Reason Status
Class II June 2, 2021 Cardinal Health Inc. CGMP Deviations: Intermittent exposure to temperature excursion during storage. Terminated

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
41520-131-08 41520-131 American Sales Company 1 BOTTLE in 1 CARTON (41520-131-08) / 120 mL in 1 BOTTLE July 27, 2017
37808-131-08 37808-131 H E B 1 BOTTLE in 1 CARTON (37808-131-08) / 120 mL in 1 BOTTLE April 16, 2018
68788-8286-1 68788-8286 Preferred Pharmaceuticals Inc. 1 BOTTLE in 1 CARTON (68788-8286-1) / 120 mL in 1 BOTTLE November 29, 2022
70677-1058-1 70677-1058 STRATEGIC SOURCING SERVICES LLC 1 BOTTLE in 1 CARTON (70677-1058-1) / 120 mL in 1 BOTTLE July 19, 2023
62011-0305-1 62011-0305 Strategic Sourcing Services LLC 1 BOTTLE in 1 CARTON (62011-0305-1) / 120 mL in 1 BOTTLE November 15, 2016
51672-2073-4 51672-2073 Sun Pharmaceutical Industries, Inc. 1 BOTTLE in 1 CARTON (51672-2073-4) / 60 mL in 1 BOTTLE August 20, 2004
51672-2073-5 51672-2073 Sun Pharmaceutical Industries, Inc. 1 BOTTLE in 1 CARTON (51672-2073-5) / 180 mL in 1 BOTTLE August 20, 2004
51672-2073-8 51672-2073 Sun Pharmaceutical Industries, Inc. 1 BOTTLE in 1 CARTON (51672-2073-8) / 120 mL in 1 BOTTLE August 20, 2004
51672-2085-1 51672-2085 Sun Pharmaceutical Industries, Inc. 1 BOTTLE in 1 CARTON (51672-2085-1) / 240 mL in 1 BOTTLE August 20, 2004
51672-2085-4 51672-2085 Sun Pharmaceutical Industries, Inc. 1 BOTTLE in 1 CARTON (51672-2085-4) / 60 mL in 1 BOTTLE August 20, 2004
51672-2085-5 51672-2085 Sun Pharmaceutical Industries, Inc. 1 BOTTLE in 1 CARTON (51672-2085-5) / 180 mL in 1 BOTTLE August 20, 2004
51672-2085-8 51672-2085 Sun Pharmaceutical Industries, Inc. 1 BOTTLE in 1 CARTON (51672-2085-8) / 120 mL in 1 BOTTLE August 20, 2004
51672-2108-1 51672-2108 Sun Pharmaceutical Industries, Inc. 1 BOTTLE in 1 CARTON (51672-2108-1) / 240 mL in 1 BOTTLE December 8, 2016
51672-2108-8 51672-2108 Sun Pharmaceutical Industries, Inc. 1 BOTTLE in 1 CARTON (51672-2108-8) / 120 mL in 1 BOTTLE December 8, 2016
51672-2131-1 51672-2131 Sun Pharmaceutical Industries, Inc. 1 BOTTLE in 1 CARTON (51672-2131-1) / 240 mL in 1 BOTTLE March 17, 2017
51672-2131-4 51672-2131 Sun Pharmaceutical Industries, Inc. 1 BOTTLE in 1 CARTON (51672-2131-4) / 60 mL in 1 BOTTLE March 17, 2017
51672-2131-8 51672-2131 Sun Pharmaceutical Industries, Inc. 1 BOTTLE in 1 CARTON (51672-2131-8) / 120 mL in 1 BOTTLE March 17, 2017
0363-2131-08 0363-2131 Walgreen Company 1 BOTTLE in 1 CARTON (0363-2131-08) / 120 mL in 1 BOTTLE June 27, 2017
41520-131 41520-131 American Sales Company — March 17, 2017
37808-131 37808-131 H E B — March 17, 2017
68788-8286 68788-8286 Preferred Pharmaceuticals Inc. — November 29, 2022
70677-1058 70677-1058 STRATEGIC SOURCING SERVICES LLC — July 19, 2023
62011-0305 62011-0305 Strategic Sourcing Services LLC — August 20, 2004
51672-2073 51672-2073 Sun Pharmaceutical Industries, Inc. — August 20, 2004
51672-2085 51672-2085 Sun Pharmaceutical Industries, Inc. — August 20, 2004
51672-2108 51672-2108 Sun Pharmaceutical Industries, Inc. — December 8, 2016
51672-2131 51672-2131 Sun Pharmaceutical Industries, Inc. — March 17, 2017
0363-2131 0363-2131 Walgreen Company — March 17, 2017

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Drug Labeling FDA / NLM Prescribing information reproduced above
FAERS FDA Adverse event report counts
Enforcement FDA Recall records

Generated September 25, 2026 · 11 sections on this page.