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BRONCOCHEM

Acetaminophen-Dextromethorphan HBr-Phenylephrine HCl-Chlorpheniramine Maleate · Tablet, Coated

Over-the-counter C TE AB 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
BRONCOCHEM COLD AND FLU CAPLETS
Generic name
Acetaminophen-Dextromethorphan HBr-Phenylephrine HCl-Chlorpheniramine Maleate
Dosage form
Tablet, Coated
Route
Oral
Marketing category
OTC MONOGRAPH DRUG · OTC MONO
Labeler
LABORATORIO MAGNACHEM INTERNATIONAL SRL
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
7
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
Acetaminophen 325 mg/1 313782 View
Chlorpheniramine Maleate 3 mg/1 1087459 View
Chlorpheniramine Maleate 4 mg/1 1087459 View
Dextromethorphan Hydrobromide 20 mg/1 1094538 View
Dextromethorphan Hydrobromide 30 mg/1 1094538 View
Phenylephrine Hydrochloride 10 mg/1 1232651 View
Phenylephrine Hydrochloride 5 mg/1 1232651 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet, Coated
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
Adrenergic alpha1-Agonists [MoA] MoA 9 members — no class page
Histamine H1 Receptor Antagonists [MoA] MoA All 136 members
Histamine-1 Receptor Antagonist [EPC] EPC All 134 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
alpha-1 Adrenergic Agonist [EPC] EPC 9 members — no class page

Regulatory status

Source: Drugs@FDANDC Directory
Application number
200263
Application type
C
Approval date
June 19, 2012
Sponsor
ZHEJIANG
Products on application
3
Submissions recorded
3
Products approved under application 200263.
Product Trade name Form Strength Ingredient Status TE Flags
200263-001 SUMATRIPTAN SUCCINATE TABLET SUMATRIPTAN SUCCINATE Prescription AB
200263-002 SUMATRIPTAN SUCCINATE TABLET SUMATRIPTAN SUCCINATE Prescription AB
200263-003 SUMATRIPTAN SUCCINATE TABLET SUMATRIPTAN SUCCINATE Prescription AB

Therapeutic equivalence

Source: Orange Book
TE code
AB
Reference Listed Drug
No
Reference Standard
No

What this rating means: Therapeutically equivalent — bioequivalence demonstrated by in vivo or in vitro testing

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Approval history

Source: Drugs@FDA
Most recent submissions on application 200263.
Type No. Action Status Date Review
Supplement 2 Labeling Approved July 16, 2020 Standard
Supplement 1 Labeling Approved June 25, 2020 Standard
Original application 1 Not Applicable Approved June 19, 2012 —

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20241126). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20241126

Indications and Usage

openFDA Drug Labeling

Indications and Usage Bronchial congestion, irritation of the respiratory passages, nasal congestion. Antitussive, temporary reliev of allergy symptoms including runny nose, sneezing, stuffy nose, itchy nose, itchy throat, irritated and watery eyes, allergy rhinitis

Purpose

openFDA Drug Labeling

Purpose Analgesic Antihistaminic Antitussive Descongestant

Dosage and Administration

openFDA Drug Labeling

Indications and Usage Adults and children 12 years and over, take one tablet every 6 hours. Do not exceed 4 doses in a 24 hour period

Warnings

openFDA Drug Labeling

Warnings Unless directed by a physician do not take this product if persistent or chronic cough such as occurs with, smoking, asthma, chronic bronchitis, emphysema, or if cough is accompained by excessive phlem (mucus). Likewise if you have heart disease, diabetes, or difficulty in urination due to enlargement of the prostate gland, do not take this product unless directed by a physician. If nervousness, dizziness, or sleeplessness occurs, discontinue use or consult a doctor. If symptoms do not improve within 7 days or are accompanied by fever, consult a doctor. A persistent cough may be a sign of a serius condition. If cough or other symptoms persist or not improve with any drug, if you are pregnant or nursing a baby, seeh the advice of a health professional before using this product. Unless directed by a doctor, do not take this product if you are presently taking another product containing pseudoephedryne HCl, or if you are taking this product precaution must be taken when driving a motor vehicle or operating machinery.

Drug Interactions

openFDA Drug Labeling

Drug Interactions Do not use if you are taking a prescription monoamine oxidase inhibitor (MAOI), (Certain drugs for depression, psychiatric or emotional conditions, or Parkinsons disease) or for 2 weeks after stopping that MAOI drug, if you are uncertain whether your prescription drug contains an MAOI, consult a health professional before taking this product

Active Ingredient

openFDA Drug Labeling

Active Ingredients Acetaminofen Dextromethorphan HBr Phenylephryne HCL Chlorpheniramine Maleate

Adverse event reports

Source: openFDA FAERS
679,519
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: ACETAMINOPHEN. 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
65131-101-11 65131-101 LABORATORIO MAGNACHEM INTERNATIONAL SRL 50 POUCH in 1 BOX (65131-101-11) / 2 TABLET, COATED in 1 POUCH April 21, 2025
65131-111-95 65131-111 LABORATORIO MAGNACHEM INTERNATIONAL SRL 50 POUCH in 1 BOX (65131-111-95) / 2 TABLET, COATED in 1 POUCH January 2, 2024
65131-101 65131-101 LABORATORIO MAGNACHEM INTERNATIONAL SRL — January 1, 2010
65131-111 65131-111 LABORATORIO MAGNACHEM INTERNATIONAL SRL — January 1, 2010

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
Orange Book FDA Therapeutic equivalence codes, reference drug flags, patents, exclusivity
Drug Labeling FDA / NLM Prescribing information reproduced above
FAERS FDA Adverse event report counts

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