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good sense allergy relief

Loratadine · Tablet

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
good sense allergy relief
Generic name
Loratadine
Dosage form
Tablet
Route
Oral
Marketing category
ANDA · ANDA
Labeler
A-S Medication Solutions
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
2
NDC product codes
6
Packages
15
Data completeness
82% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Diphenhydramine Hydrochloride 25 mg/1 1049630 View
Loratadine 10 mg/1 311372 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet
Route of administration
Oral
Presentations
21

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Histamine H1 Receptor Antagonists [MoA] MoA All 136 members
Histamine-1 Receptor Antagonist [EPC] EPC All 134 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
076301
Application type
ANDA · Abbreviated New Drug Application
Approval date
June 25, 2004
Sponsor
PERRIGO
Products on application
1
Submissions recorded
3
Products approved under application 076301.
Product Trade name Form Strength Ingredient Status TE Flags
076301-001 LORATADINE TABLET LORATADINE Over-the-counter —

Approval history

Source: Drugs@FDA
Most recent submissions on application 076301.
Type No. Action Status Date Review
Supplement 25 Labeling Approved September 23, 2011 —
Supplement 21 Labeling Approved March 20, 2009 —
Original application 1 Approved June 25, 2004 —

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20240327). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20240327 HUMAN OTC DRUG · 20240204 HUMAN OTC DRUG · 20240201

Indications and Usage

openFDA Drug Labeling

Uses • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: • runny nose • sneezing • itchy, watery eyes • itching of the nose or throat • temporarily relieves these symptoms due to the common cold: • runny nose • sneezing

Purpose

openFDA Drug Labeling

Purpose Antihistamine

Dosage and Administration

openFDA Drug Labeling

Directions • take every 4 to 6 hours, or as directed by a doctor • do not take more than 6 doses in 24 hours adults and children 12 years and over 1 to 2 tablets children 6 to under 12 years 1 tablet children under 6 years do not use

Warnings

openFDA Drug Labeling

Warnings Do not use • to make a child sleepy • with any other product containing diphenhydramine, even one used on skin Ask a doctor before use if you have • a breathing problem such as emphysema or chronic bronchitis • glaucoma • trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers When using this product • marked drowsiness may occur • avoid alcoholic drinks • alcohol, sedatives, and tranquilizers may increase drowsiness • be careful when driving a motor vehicle or operating machinery • excitability may occur, especially in children 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 • to make a child sleepy • with any other product containing diphenhydramine, even one used on skin

Ask a Doctor

openFDA Drug Labeling

Ask a doctor before use if you have • a breathing problem such as emphysema or chronic bronchitis • glaucoma • trouble urinating due to an enlarged prostate gland

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 tablet) Diphenhydramine HCl 25 mg

How Supplied / Storage and Handling

openFDA Drug Labeling

HOW SUPPLIED Product: 50090-7048 NDC: 50090-7048-5 90 TABLET in a BOTTLE / 1 in a CARTON NDC: 50090-7048-0 10 TABLET in a BOTTLE NDC: 50090-7048-4 30 TABLET in a BOTTLE / 1 in a CARTON

Adverse event reports

Source: openFDA FAERS
172,003
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: DIPHENHYDRAMINE HYDROCHLORIDE. 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.

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
50090-7048-0 50090-7048 A-S Medication Solutions 10 TABLET in 1 BOTTLE (50090-7048-0) January 15, 2024
50090-7048-4 50090-7048 A-S Medication Solutions 1 BOTTLE in 1 CARTON (50090-7048-4) / 30 TABLET in 1 BOTTLE January 15, 2024
50090-7048-5 50090-7048 A-S Medication Solutions 1 BOTTLE in 1 CARTON (50090-7048-5) / 90 TABLET in 1 BOTTLE January 15, 2024
50090-7049-4 50090-7049 A-S Medication Solutions 1 BOTTLE in 1 CARTON (50090-7049-4) / 30 TABLET in 1 BOTTLE January 15, 2024
50090-7051-0 50090-7051 A-S Medication Solutions 8 BOTTLE in 1 CASE (50090-7051-0) / 90 TABLET in 1 BOTTLE January 15, 2024
0113-0479-62 0113-0479 L. Perrigo Company 24 BLISTER PACK in 1 CARTON (0113-0479-62) / 1 TABLET in 1 BLISTER PACK August 20, 1991
0113-0479-78 0113-0479 L. Perrigo Company 1 BOTTLE in 1 CARTON (0113-0479-78) / 100 TABLET in 1 BOTTLE October 6, 1993
0113-0479-79 0113-0479 L. Perrigo Company 400 TABLET in 1 BOTTLE (0113-0479-79) February 26, 2001
0113-0612-46 0113-0612 L. Perrigo Company 10 BLISTER PACK in 1 CARTON (0113-0612-46) / 1 TABLET in 1 BLISTER PACK September 21, 2004
0113-0612-65 0113-0612 L. Perrigo Company 1 BOTTLE in 1 CARTON (0113-0612-65) / 30 TABLET in 1 BOTTLE October 6, 2004
0113-0612-75 0113-0612 L. Perrigo Company 1 BOTTLE in 1 CARTON (0113-0612-75) / 90 TABLET in 1 BOTTLE June 6, 2020
0113-0612-78 0113-0612 L. Perrigo Company 1 BOTTLE in 1 CARTON (0113-0612-78) / 100 TABLET in 1 BOTTLE December 15, 2025
0113-0612-87 0113-0612 L. Perrigo Company 1 BOTTLE in 1 CARTON (0113-0612-87) / 300 TABLET in 1 BOTTLE (0113-0612-00) January 8, 2026
0113-0612-88 0113-0612 L. Perrigo Company 1 BOTTLE in 1 CARTON (0113-0612-88) / 365 TABLET in 1 BOTTLE September 21, 2004
0113-1612-95 0113-1612 L. Perrigo Company 1 BOTTLE in 1 CARTON (0113-1612-95) / 45 TABLET in 1 BOTTLE September 26, 2018
50090-7048 50090-7048 A-S Medication Solutions — September 21, 2004
50090-7049 50090-7049 A-S Medication Solutions — September 21, 2004
50090-7051 50090-7051 A-S Medication Solutions — September 21, 2004
0113-0479 0113-0479 L. Perrigo Company — August 20, 1991
0113-0612 0113-0612 L. Perrigo Company — September 21, 2004
0113-1612 0113-1612 L. Perrigo Company — September 26, 2018

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

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