dg health allergy relief — Tablet

Overview

Brand name

dg health allergy relief

Generic name

Loratadine

Dosage form

Tablet

Route

Oral

Marketing category

ANDA · ANDA

Labeler

Dolgencorp Inc

Product type

Human Otc Drug

DEA schedule

Not scheduled

Active ingredients

2

NDC product codes

2

Packages

2

Data completeness

76% 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

4

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@FDA NDC 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 20260803). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20260803 HUMAN OTC DRUG · 20260702

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 • itchy nose or throat • temporarily relieves these symptoms of 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

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
55910-806-46	55910-806	Dolgencorp Inc	2 BLISTER PACK in 1 CARTON (55910-806-46) / 5 TABLET in 1 BLISTER PACK	July 1, 2026
55910-923-78	55910-923	Dolgencorp Inc	1 BOTTLE in 1 CARTON (55910-923-78) / 100 TABLET in 1 BOTTLE	February 25, 2019
55910-806	55910-806	Dolgencorp Inc	—	April 13, 2012
55910-923	55910-923	Dolgencorp Inc	—	February 25, 2019

Related products

same generic name, other forms

dg health allergy relief Tablet, Orally Disintegrating

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.