Good Neighbor Pharmacy — Solution

Overview

Brand name

Good Neighbor Pharmacy Childrens Loratadine

Generic name

Loratadine

Dosage form

Solution

Route

Oral

Marketing category

ANDA · ANDA

Labeler

AmerisourceBergen

Product type

Human Otc Drug

DEA schedule

Not scheduled

Active ingredients

3

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
Dextromethorphan Hydrobromide	20 mg/20mL	1094538	View
Guaifenesin	400 mg/20mL	359601	View
Loratadine	5 mg/5mL	311372	View

Forms, strengths and routes

Source: NDC Directory

Dosage form

Solution

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
Decreased Respiratory Secretion Viscosity [PE]	PE	All 52 members
Expectorant [EPC]	EPC	All 48 members
Increased Respiratory Secretions [PE]	PE	All 48 members
Sigma-1 Agonist [EPC]	EPC	All 44 members
Sigma-1 Receptor Agonists [MoA]	MoA	All 44 members
Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]	EPC	All 44 members
Uncompetitive NMDA Receptor Antagonists [MoA]	MoA	All 44 members

Regulatory status

Source: Drugs@FDA NDC 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 20250812). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20250812 HUMAN OTC DRUG · 20200624

Indications and Usage

openFDA Drug Labeling

Uses ▪ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive ▪ temporarily relieves: ▪ cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants ▪ the intensity of coughing ▪ the impulse to cough to help you get to sleep

Purpose

openFDA Drug Labeling

Active ingredients (in each 20 mL) Purposes Dextromethorphan HBr 20 mg Cough suppressant Guaifenesin 400 mg Expectorant

Dosage and Administration

openFDA Drug Labeling

Directions 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 are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have ▪ persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema ▪ cough that occurs with too much phlegm (mucus) When using this product do not use more than directed Stop use and ask a doctor if ▪ cough lasts more than 7 days, comes back, or occurs with fever, rash or persistent headache that lasts. These could be signs of a serious condition. 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 at 1-800-222-2222.

Do Not Use

openFDA Drug Labeling

Do not use ▪ if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a Doctor

openFDA Drug Labeling

Ask a doctor before use if you have ▪ persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema ▪ cough that occurs with too much phlegm (mucus)

Stop Use

openFDA Drug Labeling

Stop use and ask a doctor if ▪ cough lasts more than 7 days, comes back, or occurs with fever, rash or persistent headache that lasts. These could be signs of a serious condition.

Active Ingredient

openFDA Drug Labeling

Active ingredients (in each 20 mL) Purposes Dextromethorphan HBr 20 mg Cough suppressant Guaifenesin 400 mg Expectorant

Adverse event reports

Source: openFDA FAERS

202,963

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: GUAIFENESIN. 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
46122-840-29	46122-840	AMERISOURCE BERGEN	180 mL in 1 BOTTLE (46122-840-29)	May 4, 2026
24385-531-26	24385-531	AmerisourceBergen	1 BOTTLE in 1 CARTON (24385-531-26) / 120 mL in 1 BOTTLE	August 20, 2004
46122-840	46122-840	AMERISOURCE BERGEN	—	May 4, 2026
24385-531	24385-531	AmerisourceBergen	—	August 20, 2004

Related products

same generic name, other forms

Good Neighbor Pharmacy Ointment

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.