RYNEX PSE

Manufacturer: EDWARDS PHARMACEUTICALS, INC.
Effective date: 2026-03-05
Label type: HUMAN OTC DRUG LABEL
Version: 10
Source: full-release
Hydrated at: 2026-06-01 01:49:04

Label at a glance#

ProductRYNEX PSE

Active ingredientBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE

Label structure9 sections

Indications and uses

temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other respiratory allergies: runny nose sneezing itching of the nose or throat itchy, watery eyes nasal congestion 'reduces swelling of nasal passages

Dosage and administration

Do not exceed recommended dosage Adults and children 12 years of age and over: 4 teaspoonfuls (20 mL) every 4 to 6 hours, not to exceed 16 teaspoonfuls in 24 hours Children 6 to under 12 years of age: 2 teaspoonfuls (10 mL) every 4 to 6 hours, not to exceed 8 teaspoonfuls in 24 hours Children under 6 years of age Consult a doctor

Storage and handling

Store at 59° - 86° F (15° - 30 C) [see USP for Controlled Room Temperature]

Contacts and useful links#

PhoneLabel contact1-800-543-9560

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active Ingredients (in each 5 mL teaspoonful)	Purpose
Brompheniramine Maleate 1 mg	Antihistamine
Pseudoephedrine HCI 15 mg	Decongestant

Uses

INDICATIONS & USAGE SECTION

temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other respiratory allergies:

runny nose
sneezing
itching of the nose or throat
itchy, watery eyes
nasal congestion 'reduces swelling of nasal passages

Warnings

WARNINGS SECTION

On not exceed recommended dosage.

Do not use this product

OTC - DO NOT USE SECTION

if you are now taking a prescription monoamine oxidase inhibitor (MA0I) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MA0I drug. If you do not know if your prescription drug contains an MA0I, ask a doctor or pharmacist before taking this product

Do not use this product, unless directed by a doctor, if you have

OTC - DO NOT USE SECTION

a breathing problem such as emphysema or chronic bronchitis
glaucoma
heart disease
thyroid disease
diabetes mellitus
difficulty in urination due to enlargement of the prostate gland

OTC - DO NOT USE SECTION

Do not lake this product if you are taking sedatives or tranquilizers, without first consulting your doctor.

When using this product

OTC - WHEN USING SECTION

excitability may occur, especially in children
may cause drowsiness
alcohol, sedatives and tranquilizers may increase drowsiness effect
avoid alcoholic beverages
use caution when driving a motor vehicle or operating machinery

Stop use and ask doctor If

OTC - STOP USE SECTION

nervousness, dizziness, or sleeplessness occur
If symptoms do not improve within 7 days or are accompanied by fever, consult a doctor
new symptoms occur

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

Do not exceed recommended dosage

Adults and children 12 years of age and over:	4 teaspoonfuls (20 mL) every 4 to 6 hours, not to exceed 16 teaspoonfuls in 24 hours
Children 6 to under 12 years of age:	2 teaspoonfuls (10 mL) every 4 to 6 hours, not to exceed 8 teaspoonfuls in 24 hours
Children under 6 years of age	Consult a doctor

Other information

STORAGE AND HANDLING SECTION

Store at 59° - 86° F (15° - 30 C) [see USP for Controlled Room Temperature]

Inactive ingredients

INACTIVE INGREDIENT SECTION

Citric Acid, FD&C Red #40, FD&C Yellow #6, Methyl Paraben, Orange flavor, Potassium Citrate, Potassium Sorbate, Propyl Paraben, Propylene Glycol, Purified Water, Sorbitol Solution 70%, Sucralose

Question? Comments?

OTC - QUESTIONS SECTION

Call 1-800-543-9560

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label

NDC 00485-0206-16

Rynex PSE

Antihistamine • Decongestant

Sugar Free • Alcohol Free •

Gluten Free

Each teaspoonful (5 mL)

for oral administration contains:

Brompheniramine Maleate 1 mg

Pseudoephedrine HCI 15 mg

Orange Flavor

FOR PROFESSIONAL USE ONLY

This bottle is not to be

dispensed to consumer.

Tamper evident by foil seal under cap.

Do not used foil seal is broken or missing.

Dispense in a tight container with a child-

resistant cap.

Manufactured for:

EDWARDS

Pharmaceuticals, Inc.

Ripley, MS 38663

16oz. (473 mL)

RxCUI, Display, Full name table
RxCUI	Display	Full name	Type	Form / route
1053258	Brompheniramine/Phenylephrine (Oral Liquid)	brompheniramine maleate 0.2 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution	SCD Active
1098498	Brompheniramine/Pseudoephedrine (Oral Liquid)	brompheniramine maleate 0.2 MG/ML / pseudoephedrine hydrochloride 3 MG/ML Oral Solution	SCD Active

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1098498	brompheniramine maleate 1 MG / pseudoephedrine HCl 15 MG in 5 mL Oral Solution	PSN	10
1098498	brompheniramine maleate 0.2 MG/ML / pseudoephedrine hydrochloride 3 MG/ML Oral Solution	SCD	10
1098498	brompheniramine maleate 1 MG / pseudoephedrine hydrochloride 15 MG per 5 ML Oral Solution	SY	10

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
PSEUDOEPHEDRINE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
0fdb98e2-b951-a1ce-5715-2b187ba500ef	Product name	4	20170718
e974e22d-8688-7d92-1e87-40c1079e170c	Product name	3	20151125
e8718272-64cb-4436-969b-176c3067c8f4	Product name	1	20150609
30c51294-7ae9-8007-7de6-58222684a0be	Product name	1	20140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66	Product name	1	20140508
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
70a83adc-6047-bbea-5a08-dfd304aa47d2	Product name	1	20140508
858ce051-9941-aafc-8c7c-44a8e0227463	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
b893258d-0942-3d8a-3411-056ea0788ff5	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0485-0206-16	2024-01-31	C162847	48780-1	9d75b9d0-101e-f424-e053-dadaa90a57ce	Ed-RynexPSE 0206
0485-0206-16	2024-01-31	C162847	48780-1	9d75b9d0-101e-f424-e053-dadaa90a57ce	RYNEX PSE
0485-0206-16	2020-04-08	C162847	48780-1	9d75b9d0-101e-f424-e053-dadaa90a57ce	Ed-RynexPSE 0206
0485-0206-16	2020-04-08	C162847	48780-1	9d75b9d0-101e-f424-e053-dadaa90a57ce	RYNEX PSE
0485-0206-16	2020-01-31	C162847	48780-1	9d75b9d0-101e-f424-e053-dadaa90a57ce	Ed-RynexPSE 0206
0485-0206-16	2020-01-31	C162847	48780-1	9d75b9d0-101e-f424-e053-dadaa90a57ce	RYNEX PSE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0485-0206-16	RYNEX PSE	473 mL in 1 BOTTLE, PLASTIC	LIQUID	473		10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0485-0206-16	ML - Milliliter	0485-0206	f1ca09bc-f40d-400b-9806-36bf1d7f3938	1	2013-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
BROMPHENIRAMINE MALEATE	ACTIVE INGREDIENT	IXA7C9ZN03	2
PSEUDOEPHEDRINE HYDROCHLORIDE	ACTIVE INGREDIENT	6V9V2RYJ8N	2
BROMPHENIRAMINE	ACTIVE MOIETY	H57G17P2FN	2
PSEUDOEPHEDRINE	ACTIVE MOIETY	7CUC9DDI9F	2
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	2
POTASSIUM CITRATE	INACTIVE INGREDIENT	EE90ONI6FF	2
POTASSIUM SORBATE	INACTIVE INGREDIENT	1VPU26JZZ4	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	2
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	2
SORBITOL	INACTIVE INGREDIENT	506T60A25R	2
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	2

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

RYNEX PSE
BROMPHENIRAMINE MALEATE and PSEUDOEPHEDRINE HYDROCHLORIDE
CITRIC ACID MONOHYDRATE
FD&C RED NO. 40
FD&C YELLOW NO. 6
METHYLPARABEN
POTASSIUM CITRATE
POTASSIUM SORBATE
PROPYLPARABEN
PROPYLENE GLYCOL
WATER
SORBITOL
SUCRALOSE
BROMPHENIRAMINE MALEATE
BROMPHENIRAMINE
PSEUDOEPHEDRINE HYDROCHLORIDE
PSEUDOEPHEDRINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0485-0206	0485-0206-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CITRIC ACID MONOHYDRATE	2968PHW8QP	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
FD&C YELLOW NO. 6	H77VEI93A8	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
POTASSIUM CITRATE	EE90ONI6FF	IACT
POTASSIUM SORBATE	1VPU26JZZ4	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
WATER	059QF0KO0R	IACT
SORBITOL	506T60A25R	IACT
SUCRALOSE	96K6UQ3ZD4	IACT
BROMPHENIRAMINE MALEATE	IXA7C9ZN03	ACTIB
PSEUDOEPHEDRINE HYDROCHLORIDE	6V9V2RYJ8N	ACTIB

Source Document#

Source XML · Source PDF

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
9	2025-12-30	monthly-update	2026-06-03 17:47:01

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 3 · 122 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	SYRUP / ORAL		80 mg	Exact identifier — unii+route 36 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	SOLUTION / ORAL	1000 mg/15ml		Exact identifier — unii+route 24 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	SUSPENSION/ DROPS / ORAL		1 mg	Exact identifier — unii+route 44 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	POWDER, FOR SOLUTION / ORAL		414 mg	Exact identifier — unii+route 36 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	TABLET / ORAL		6 mg	Exact identifier — unii+route 24 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, EXTENDED RELEASE / ORAL		1 mg	Exact identifier — unii+route 44 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	TABLET, CHEWABLE / ORAL	40 mg		Exact identifier — unii+route 44 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	TABLET, COATED / ORAL	NA		Exact identifier — unii+route 24 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	SYRUP / ORAL		80 mg	Exact identifier — unii+route 36 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	SOLUTION / ORAL		38 mg	Exact identifier — unii+route 44 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	LIQUID / ORAL		114 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	LOZENGE / ORAL		115 mg	Exact identifier — unii+route 36 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	LIQUID / ORAL		53460 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	SYRUP / ORAL	2 mg/1ml		Exact identifier — unii+route 24 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	LIQUID / ORAL		53460 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	LIQUID / ORAL		162 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, LIQUID FILLED / ORAL		1 mg	Exact identifier — unii+route 44 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	CAPSULE / ORAL	NA		Exact identifier — unii+route 24 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	CONCENTRATE / ORAL		1 mg	Exact identifier — unii+route 24 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	TABLET, COATED / ORAL	NA		Exact identifier — unii+route 24 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	SUSPENSION / ORAL		400 mg	Exact identifier — unii+route 24 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	TABLET / ORAL		45 mg	Exact identifier — unii+route 36 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	CAPSULE / ORAL	NA		Exact identifier — unii+route 24 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	FILM, SOLUBLE / ORAL		33 mg	Exact identifier — unii+route 36 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	TABLET, CHEWABLE / ORAL		28 mg	Exact identifier — unii+route 36 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	SOLUTION / ORAL		800 mg	Exact identifier — unii+route 36 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	TABLET, FILM COATED / ORAL	2.5 mg		Exact identifier — unii+route 44 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	TABLET, EFFERVESCENT / ORAL		1080 mg	Exact identifier — unii+route 36 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	LOZENGE / ORAL		115 mg	Exact identifier — unii+route 36 equally ranked IID candidates
POTASSIUM CITRATE	POTASSIUM CITRATE	EE90ONI6FF	POWDER, FOR SOLUTION / ORAL		570 mg	Exact identifier — unii+route 6 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CONCENTRATE / ORAL	0.04 mg/1ml		Exact identifier — unii+route 44 equally ranked IID candidates
POTASSIUM CITRATE	POTASSIUM CITRATE	EE90ONI6FF	SUSPENSION / ORAL	NA		Exact identifier — unii+route 6 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	SUSPENSION / ORAL		383 mg	Exact identifier — unii+route 36 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	SUSPENSION / ORAL		400 mg	Exact identifier — unii+route 24 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	DROPS / ORAL	NA		Exact identifier — unii+route 44 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	ELIXIR / ORAL	12.5 mg/5ml		Exact identifier — unii+route 44 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	POWDER, FOR SOLUTION / ORAL	0.33 mg/5ml		Exact identifier — unii+route 44 equally ranked IID candidates
POTASSIUM CITRATE	POTASSIUM CITRATE	EE90ONI6FF	POWDER, FOR SOLUTION / ORAL		570 mg	Exact identifier — unii+route 6 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	TROCHE / ORAL		60 mg	Exact identifier — unii+route 36 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	TABLET / ORAL		7 mg	Exact identifier — unii+route 44 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	LIQUID / ORAL		162 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	TABLET, EXTENDED RELEASE / ORAL	2.22 mg		Exact identifier — unii+route 44 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	POWDER, FOR SUSPENSION / ORAL		19 mg	Exact identifier — unii+route 24 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	TABLET, FOR SUSPENSION / ORAL		65 mg	Exact identifier — unii+route 36 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	DROPS / ORAL	NA		Exact identifier — unii+route 44 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	PASTE / ORAL		48 mg	Exact identifier — unii+route 24 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, DELAYED RELEASE PELLETS / ORAL	0.02 mg		Exact identifier — unii+route 44 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE / ORAL		16 mg	Exact identifier — unii+route 44 equally ranked IID candidates
POTASSIUM CITRATE	POTASSIUM CITRATE	EE90ONI6FF	SOLUTION / ORAL		913 mg	Exact identifier — unii+route 6 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, COATED / ORAL	NA		Exact identifier — unii+route 44 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	0.2 mg		Exact identifier — unii+route 24 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	SUSPENSION / ORAL	100 mg/5ml		Exact identifier — unii+route 44 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	FILM, SOLUBLE / ORAL		33 mg	Exact identifier — unii+route 36 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	POWDER, FOR SUSPENSION / ORAL		19 mg	Exact identifier — unii+route 24 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii+route 44 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	GRANULE, FOR SUSPENSION / ORAL		80 mg	Exact identifier — unii+route 24 equally ranked IID candidates
POTASSIUM CITRATE	POTASSIUM CITRATE	EE90ONI6FF	SOLUTION / ORAL		913 mg	Exact identifier — unii+route 6 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	FILM / ORAL		1 mg	Exact identifier — unii+route 36 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	POWDER, FOR SOLUTION / ORAL	0.33 mg/5ml		Exact identifier — unii+route 44 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, DELAYED RELEASE / ORAL		2 mg	Exact identifier — unii+route 44 equally ranked IID candidates

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
RYNEX PSE	BROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE	EDWARDS PHARMACEUTICALS, INC.	2f2d9b5a-f66b-4928-8d43-402ef9efcfdf	2026-03-05	Warnings	Exact identifier ndc (package): 0485-0206-16 ndc (product): 0485-0206 ndc11 (package): 00485020616 spl id: 4c48242c-1746-1a49-e063-6294a90ac81d spl set id: 2f2d9b5a-f66b-4928-8d43-402ef9efcfdf

Reported adverse events (FAERS/openFDA)#

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

RYNEX PSE

Label at a glance#

Indications and uses

Dosage and administration

Storage and handling

Contacts and useful links#

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Uses

Warnings

Do not use this product

Do not use this product, unless directed by a doctor, if you have

OTC - DO NOT USE SECTION

When using this product

Stop use and ask doctor If

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

Other information

Inactive ingredients

Question? Comments?

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

Related RxNorm Concepts#

DailyMed RxNorm Mappings#

DailyMed Pharmacologic Classes#

DailyMed Product Concepts#

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

Products#

NDC Codes#

Ingredients#

Source Document#

Older Hydrated Versions#

Inactive ingredient matches#

openFDA label cross-check#

Reported adverse events (FAERS/openFDA)#