BRONCOCHEM

Manufacturer: LABORATORIO MAGNACHEM INTERNATIONAL SRL
Effective date: 2024-11-26
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: full-release
Hydrated at: 2026-06-01 00:39:24

Label at a glance#

ProductBRONCOCHEM COLD AND FLU CAPLETS

Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, CHLORPHENIRAMINE MALEATE

Label structure9 sections

Indications and uses

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

Label contents#

Full prescribing information#

Warnings

WARNINGS SECTION

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.

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Acetaminofen

Dextromethorphan HBr

Phenylephryne HCL

Chlorpheniramine Maleate

Purpose

OTC - PURPOSE SECTION

Analgesic

Antihistaminic

Antitussive

Descongestant

Keep Out Of The Reach Of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental overdose, seek professional assistance or contact a poison control center immediately

Indications and Usage

INDICATIONS & USAGE SECTION

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

Indications and Usage

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years and over, take one tablet every 6 hours.

Do not exceed 4 doses in a 24 hour period

Drug Interactions

DRUG INTERACTIONS SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Cellulose Microcrystalline, Colloidal Silicon dioxide, Green Opadry, Magnesium Stearate, Pregelatinized Starch, PEG 4000

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionBC&FBOXimage descriptionBC&FBOXimage descriptionBC&FBOX

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1744049	acetaminophen 325 MG / chlorpheniramine maleate 3 MG / dextromethorphan HBr 30 MG / phenylephrine HCl 5 MG Oral Tablet	PSN	4
1744049	acetaminophen 325 MG / chlorpheniramine maleate 3 MG / dextromethorphan hydrobromide 30 MG / phenylephrine hydrochloride 5 MG Oral Tablet	SCD	4
1744049	APAP 325 MG / Chlorpheniramine Maleate 3 MG / Dextromethorphan Hydrobromide 30 MG / Phenylephrine Hydrochloride 5 MG Oral Tablet	SY	4

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
CHLORPHENIRAMINE Pharmacologic Class Indexing	3	Indexing - Pharmacologic Class	20180813
DEXTROMETHORPHAN Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813
PHENYLEPHRINE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e4e263da-1c53-440f-bb80-b7a575843b5a	Product name	1	20260313
d2168cac-a261-415a-9c78-3522859fa720	Product name	3	20251124
05a8cdd1-eeb8-409e-b938-0778225eca7d	Product name	4	20250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9	Product name	8	20250220
f489e8f3-5c9e-4818-b539-a73587edcfc7	Product name	2	20240229
0f7ae452-206d-4fc4-868d-56fc47074084	Product name	1	20231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3df	Product name	2	20190930
d17a97fa-387f-690e-d2be-0083ab044a03	Product name	3	20170725
0fdb98e2-b951-a1ce-5715-2b187ba500ef	Product name	4	20170718
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814	Product name	3	20150910
c6fba691-a132-4ede-95c6-f8c6bd696636	Product name	1	20150902
c0200ab5-4954-454e-9676-30b741b245bd	Product name	1	20150730
42f3c020-f1b3-89bc-7bdc-e1f10e680485	Product name	1	20140508
e949165d-714d-e548-2b76-0cb5def16f30	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
65131-111-95	BRONCOCHEMCOLD AND FLU CAPLETS	50 in 1 BOX	TABLET, COATED	50		4
65131-111-95	BRONCOCHEMCOLD AND FLU CAPLETS	2 in 1 POUCH	TABLET, COATED	2		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65131-111	BRONCOCHEM COLD AND FLU CAPLETS (ACETAMINOPHEN-DEXTROMETHORPHAN HBR-PHENYLEPHRINE HCL-CHLORPHENIRAMINE MALEATE) TABLET, COATED [LABORATORIO MAGNACHEM INTERNATIONAL SRL]	4	Current NDC, Legacy NDC, 2 package rows	20241127_ac4f6a39-e455-4d33-8bb8-ae8dc6ebc2f6.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

BRONCOCHEM COLD AND FLU CAPLETS
Acetaminophen-Dextromethorphan HBr-Phenylephrine HCl-Chlorpheniramine Maleate
ACETAMINOPHEN
DEXTROMETHORPHAN HYDROBROMIDE
DEXTROMETHORPHAN
PHENYLEPHRINE HYDROCHLORIDE
PHENYLEPHRINE
CHLORPHENIRAMINE MALEATE
CHLORPHENIRAMINE
CELLULOSE, MICROCRYSTALLINE
STARCH, PREGELATINIZED CORN
SILICON DIOXIDE
MAGNESIUM STEARATE
PEG-80 STEARATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
65131-111	65131-111-95

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ACETAMINOPHEN	362O9ITL9D	ACTIB
DEXTROMETHORPHAN HYDROBROMIDE	9D2RTI9KYH	ACTIB
PHENYLEPHRINE HYDROCHLORIDE	04JA59TNSJ	ACTIM
CHLORPHENIRAMINE MALEATE	V1Q0O9OJ9Z	ACTIB
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
STARCH, PREGELATINIZED CORN	O8232NY3SJ	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
PEG-80 STEARATE	1X2OAT3BFK	IACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A200263-001	SUMATRIPTAN SUCCINATE	SUMATRIPTAN SUCCINATE	EQ 25MG BASE	TABLET / ORAL	AB	2012-06-19
A200263-002	SUMATRIPTAN SUCCINATE	SUMATRIPTAN SUCCINATE	EQ 50MG BASE	TABLET / ORAL	AB	2012-06-19
A200263-003	SUMATRIPTAN SUCCINATE	SUMATRIPTAN SUCCINATE	EQ 100MG BASE	TABLET / ORAL	AB	2012-06-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A200263-001	AB
A200263-002	AB
A200263-003	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A200263-001	SUMATRIPTAN SUCCINATE	EQ 25MG BASE	TABLET / ORAL	AB	2012-06-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A200263-002	SUMATRIPTAN SUCCINATE	EQ 50MG BASE	TABLET / ORAL	AB	2012-06-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A200263-003	SUMATRIPTAN SUCCINATE	EQ 100MG BASE	TABLET / ORAL	AB	2012-06-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A200263-001	SUMATRIPTAN SUCCINATE	EQ 25MG BASE	TABLET / ORAL	AB	2012-06-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200263-002	SUMATRIPTAN SUCCINATE	EQ 50MG BASE	TABLET / ORAL	AB	2012-06-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200263-003	SUMATRIPTAN SUCCINATE	EQ 100MG BASE	TABLET / ORAL	AB	2012-06-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A200263-001	SUMATRIPTAN SUCCINATE	EQ 25MG BASE	TABLET / ORAL	AB	2012-06-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200263-002	SUMATRIPTAN SUCCINATE	EQ 50MG BASE	TABLET / ORAL	AB	2012-06-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200263-003	SUMATRIPTAN SUCCINATE	EQ 100MG BASE	TABLET / ORAL	AB	2012-06-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200263-001	SUMATRIPTAN SUCCINATE	EQ 25MG BASE	TABLET / ORAL	AB	2012-06-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200263-002	SUMATRIPTAN SUCCINATE	EQ 50MG BASE	TABLET / ORAL	AB	2012-06-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200263-003	SUMATRIPTAN SUCCINATE	EQ 100MG BASE	TABLET / ORAL	AB	2012-06-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200263-001	SUMATRIPTAN SUCCINATE	EQ 25MG BASE	TABLET / ORAL	AB	2012-06-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200263-002	SUMATRIPTAN SUCCINATE	EQ 50MG BASE	TABLET / ORAL	AB	2012-06-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200263-003	SUMATRIPTAN SUCCINATE	EQ 100MG BASE	TABLET / ORAL	AB	2012-06-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200263-001	SUMATRIPTAN SUCCINATE	EQ 25MG BASE	TABLET / ORAL	AB	2012-06-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200263-002	SUMATRIPTAN SUCCINATE	EQ 50MG BASE	TABLET / ORAL	AB	2012-06-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200263-003	SUMATRIPTAN SUCCINATE	EQ 100MG BASE	TABLET / ORAL	AB	2012-06-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200263-001	SUMATRIPTAN SUCCINATE	EQ 25MG BASE	TABLET / ORAL	AB	2012-06-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200263-002	SUMATRIPTAN SUCCINATE	EQ 50MG BASE	TABLET / ORAL	AB	2012-06-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200263-003	SUMATRIPTAN SUCCINATE	EQ 100MG BASE	TABLET / ORAL	AB	2012-06-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200263-001	SUMATRIPTAN SUCCINATE	EQ 25MG BASE	TABLET / ORAL	AB	2012-06-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200263-002	SUMATRIPTAN SUCCINATE	EQ 50MG BASE	TABLET / ORAL	AB	2012-06-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200263-003	SUMATRIPTAN SUCCINATE	EQ 100MG BASE	TABLET / ORAL	AB	2012-06-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200263-001	SUMATRIPTAN SUCCINATE	EQ 25MG BASE	TABLET / ORAL	AB	2012-06-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200263-002	SUMATRIPTAN SUCCINATE	EQ 50MG BASE	TABLET / ORAL	AB	2012-06-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200263-003	SUMATRIPTAN SUCCINATE	EQ 100MG BASE	TABLET / ORAL	AB	2012-06-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200263-001	SUMATRIPTAN SUCCINATE	EQ 25MG BASE	TABLET / ORAL	AB	2012-06-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200263-002	SUMATRIPTAN SUCCINATE	EQ 50MG BASE	TABLET / ORAL	AB	2012-06-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200263-003	SUMATRIPTAN SUCCINATE	EQ 100MG BASE	TABLET / ORAL	AB	2012-06-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200263-001	SUMATRIPTAN SUCCINATE	EQ 25MG BASE	TABLET / ORAL	AB	2012-06-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200263-002	SUMATRIPTAN SUCCINATE	EQ 50MG BASE	TABLET / ORAL	AB	2012-06-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200263-003	SUMATRIPTAN SUCCINATE	EQ 100MG BASE	TABLET / ORAL	AB	2012-06-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200263-001	SUMATRIPTAN SUCCINATE	EQ 25MG BASE	TABLET / ORAL	AB	2012-06-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200263-002	SUMATRIPTAN SUCCINATE	EQ 50MG BASE	TABLET / ORAL	AB	2012-06-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200263-003	SUMATRIPTAN SUCCINATE	EQ 100MG BASE	TABLET / ORAL	AB	2012-06-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200263-001	SUMATRIPTAN SUCCINATE	EQ 25MG BASE	TABLET / ORAL	AB	2012-06-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200263-002	SUMATRIPTAN SUCCINATE	EQ 50MG BASE	TABLET / ORAL	AB	2012-06-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200263-003	SUMATRIPTAN SUCCINATE	EQ 100MG BASE	TABLET / ORAL	AB	2012-06-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200263-001	SUMATRIPTAN SUCCINATE	EQ 25MG BASE	TABLET / ORAL	AB	2012-06-19	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A200263-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A200263-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A200263-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A200263-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200263-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200263-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A200263-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200263-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200263-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200263-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200263-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200263-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200263-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200263-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200263-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200263-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200263-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200263-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200263-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200263-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200263-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200263-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200263-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200263-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200263-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200263-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200263-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200263-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200263-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200263-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200263-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200263-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200263-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200263-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200263-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200263-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200263-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200263-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200263-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200263-001	AB	1	`301d65b070ca…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BRONCOCHEM COLD AND FLU CAPLETS	ACETAMINOPHEN-DEXTROMETHORPHAN HBR-PHENYLEPHRINE HCL-CHLORPHENIRAMINE MALEATE	LABORATORIO MAGNACHEM INTERNATIONAL SRL	ac4f6a39-e455-4d33-8bb8-ae8dc6ebc2f6	2024-11-26	Warnings	Exact identifier ndc (package): 65131-111-95 ndc (product): 65131-111 ndc11 (package): 65131011195 spl id: 75397c61-93f4-4d4d-9e3a-81107ecb0932 spl set id: ac4f6a39-e455-4d33-8bb8-ae8dc6ebc2f6

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.