TRISPEC PSE Pediatric Drops Cough Suppressant Expectorant Nasal Decongestant GRAPE Flavor

Manufacturer: Deliz Pharmaceutical Corp | Woodfield Pharmaceutical, LLC
Effective date: 2015-08-28
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 22:49:33

Label at a glance#

ProductTRISPEC PSE Pediatric Drops Cough Suppressant Expectorant Nasal Decongestant GRAPE Flavor

Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE

Label structure8 sections

Indications and uses

temporarily relieves cough due to minor throat and bronchial irritation occuring with a cold or inhaled irritants helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive temporarily relieves nasal congestion

Dosage and administration

For children under 6 years of age, use enclosed dropper do not use enclosed dropper for any other drug product Children 2 to under 6 years of age: 2½ mL every 4 hours not to exceed 10 mL in 24 hours, or as directed by a doctor. Children under 2 years of age: Consult a doctor.

Contacts and useful links#

PhoneLabel contact1-787-701-3312

Label contents#

Full prescribing information#

Active ingredients (in each 5 mL)

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr, USP 10 mg

Guaifenesin, USP 187 mg

Pseudoephedrine HCl, USP 30 mg

Purpose

OTC - PURPOSE SECTION

Cough suppressant

Expectorant

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

temporarily relieves cough due to minor throat and bronchial irritation occuring with a cold or inhaled irritants
helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
temporarily relieves nasal congestion

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR SECTION

heart disease
high blood pressure
thyroid disease
diabetes
persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
cough accompanied by excessive phlegm (mugus)

When using this product

OTC - WHEN USING SECTION

do not exceed recommended dosage

Stop use and ask a doctor if

OTC - STOP USE SECTION

cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.
symptoms do not improve within 7 days or are acompanied by fever
nervousness, dizziness, or sleeplessness occur

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

For children under 6 years of age, use enclosed dropper
do not use enclosed dropper for any other drug product

Children 2 to under 6 years of age:	2½ mL every 4 hours not to exceed 10 mL in 24 hours, or as directed by a doctor.
Children under 2 years of age:	Consult a doctor.

Other information

SPL UNCLASSIFIED SECTION

Store at room temperature 15°C-30°C (59°F-86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Bitter Mask, Citric Acid Anhydrous, Glycerin, Grape Flavor, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol

Questions?

OTC - QUESTIONS SECTION

Call 1-787-701-3312. You may also report serious side effects to this phone number.

TRISPEC PSE Pediatric Drops Cough Suppressant Expectorant Nasal Decongestant GRAPE Flavor 2oz/59ml (58238-230-02)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Trispec PSE Pediatric Drops Labeling 1

Trispec PSE Pediatric Drops Labeling 2

RxCUI, Display, Full name table
RxCUI	Display	Full name	Type	Form / route
1435143	Dextromethorphan/guaiFENesin/Pseudoephedrine (Oral Liquid)	dextromethorphan hydrobromide 2 MG/ML / guaifenesin 37.4 MG/ML / pseudoephedrine hydrochloride 6 MG/ML Oral Solution	SCD Active

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1435143	dextromethorphan HBr 10 MG / guaiFENesin 187 MG / pseudoephedrine HCl 30 MG in 5 mL Oral Solution	PSN	2
1435143	dextromethorphan hydrobromide 2 MG/ML / guaifenesin 37.4 MG/ML / pseudoephedrine hydrochloride 6 MG/ML Oral Solution	SCD	2
1435143	dextromethorphan HBr 10 MG / guaifenesin 187 MG / pseudoephedrine HCl 30 MG per 5 ML Oral Solution	SY	2

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
DEXTROMETHORPHAN Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813
GUAIFENESIN Pharmacologic Class Indexing	1	Indexing - Pharmacologic Class	20211129
PSEUDOEPHEDRINE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
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
4fe95224-f543-4dbb-9445-8cca122b48c8	Product name	1	20150609
e8718272-64cb-4436-969b-176c3067c8f4	Product name	1	20150609
106ff02a-57e1-4c4c-a307-fd582ff4e311	Product name	1	20150212
30c51294-7ae9-8007-7de6-58222684a0be	Product name	1	20140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66	Product name	1	20140508
70a83adc-6047-bbea-5a08-dfd304aa47d2	Product name	1	20140508
858ce051-9941-aafc-8c7c-44a8e0227463	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
58238-230-02	2020-01-31	C162847	48780-1	9d75b9cf-d37f-f424-e053-dadaa90a57ce	TRISPEC PSE Pediatric Drops Cough Suppressant Expectorant Nasal Decongestant GRAPE Flavor

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
58238-230-02	TRISPEC PSE Pediatric Drops Cough Suppressant Expectorant Nasal Decongestant GRAPE Flavor	1 in 1 CARTON	LIQUID	1		2
58238-230-02	TRISPEC PSE Pediatric Drops Cough Suppressant Expectorant Nasal Decongestant GRAPE Flavor	60 mL in 1 BOTTLE	LIQUID	60		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58238-230	TRISPEC PSE PEDIATRIC DROPS COUGH SUPPRESSANT EXPECTORANT NASAL DECONGESTANT GRAPE FLAVOR (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [DELIZ PHARMACEUTICAL CORP]	2	Legacy NDC, 2 package rows	20170406_b4630613-c78c-4f97-bd6c-0476899f5b90.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
58238-230-02	ML - Milliliter	58238-230	9ab5b2b7-1972-44d0-a5a6-083b7652006e	1	2015-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	1
GUAIFENESIN	ACTIVE INGREDIENT	495W7451VQ	1
PSEUDOEPHEDRINE HYDROCHLORIDE	ACTIVE INGREDIENT	6V9V2RYJ8N	1
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	1
GUAIFENESIN	ACTIVE MOIETY	495W7451VQ	1
PSEUDOEPHEDRINE	ACTIVE MOIETY	7CUC9DDI9F	1
AMMONIUM GLYCYRRHIZATE	INACTIVE INGREDIENT	3VRD35U26C	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	1
POTASSIUM CITRATE	INACTIVE INGREDIENT	EE90ONI6FF	1
POTASSIUM SORBATE	INACTIVE INGREDIENT	1VPU26JZZ4	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	1
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

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

TRISPEC PSE Pediatric Drops Cough Suppressant Expectorant Nasal Decongestant GRAPE Flavor
DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE
ANHYDROUS CITRIC ACID
SODIUM CITRATE
GLYCERIN
SACCHARIN SODIUM
PROPYLENE GLYCOL
WATER
SORBITOL
DEXTROMETHORPHAN HYDROBROMIDE
DEXTROMETHORPHAN
GUAIFENESIN
PSEUDOEPHEDRINE HYDROCHLORIDE
PSEUDOEPHEDRINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
58238-230	58238-230-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ANHYDROUS CITRIC ACID	XF417D3PSL	IACT
SODIUM CITRATE	1Q73Q2JULR	IACT
GLYCERIN	PDC6A3C0OX	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
WATER	059QF0KO0R	IACT
SORBITOL	506T60A25R	IACT
DEXTROMETHORPHAN HYDROBROMIDE	9D2RTI9KYH	ACTIB
GUAIFENESIN	495W7451VQ	ACTIB
PSEUDOEPHEDRINE HYDROCHLORIDE	6V9V2RYJ8N	ACTIB

Source Document#

Source XML

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 8 · 480 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	AEROSOL / TOPICAL	19.2 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	GEL / VAGINAL		8 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	OINTMENT / RECTAL		27 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / OPHTHALMIC	0.02 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	FILM / BUCCAL	0.22 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	GEL / OPHTHALMIC	0.88 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	GEL / TOPICAL		500 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION, SOLUTION / INTRA-ARTICULAR	ADJ PH		Exact identifier — unii candidate 88 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	EMULSION / OPHTHALMIC		3 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUPPOSITORY / VAGINAL	252 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION/ DROPS / OPHTHALMIC	2.5 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	AEROSOL, FOAM / VAGINAL	6.4 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	LIQUID / RESPIRATORY (INHALATION)	10 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / EPIDURAL	0.02 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION/ DROPS / OPHTHALMIC	0.75 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION, SOLUTION, CONCENTRATE / IRRIGATION		1 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SYSTEM / TOPICAL		42 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / INFILTRATION		80 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	LIQUID / ORAL		114 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / ORAL		446 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	TABLET, FOR SUSPENSION / ORAL		65 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET, FILM COATED / ORAL	1.55 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	CONCENTRATE / ORAL		12 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SHAMPOO, SUSPENSION / TOPICAL	2 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / OPHTHALMIC	0.03 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET, ORALLY DISINTEGRATING / ORAL		7 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SHAMPOO, SUSPENSION / TOPICAL	0.25 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SYRUP / ORAL		81 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL / VAGINAL		750 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	CREAM / TOPICAL		3000 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE, COATED / ORAL	25 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	ELIXIR / ORAL	833.3 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	DROPS / NASAL	10 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	SPRAY, METERED / NASAL		2 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOAP / TOPICAL	0.76 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION, CONCENTRATE / INTRAVENOUS	50.33 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	CAPSULE, EXTENDED RELEASE / ORAL		2 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	LIQUID / RESPIRATORY (INHALATION)	0.13 %w/w		Exact identifier — unii candidate 88 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION, SOLUTION / INTRAMUSCULAR	15 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUSPENSION/ DROPS / OPHTHALMIC	0.05 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / INTRATHECAL	ADJ PH		Exact identifier — unii candidate 88 equally ranked IID candidates
POTASSIUM CITRATE	POTASSIUM CITRATE	EE90ONI6FF	SOLUTION / ORAL		913 mg	Exact identifier — unii candidate 4 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	CAPSULE / ORAL		1 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SYSTEM / IONTOPHORESIS	168.1 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	FILM, SOLUBLE / BUCCAL		1 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SYSTEM / TOPICAL		4200 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION, SOLUTION / INTRAVENOUS		396 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	OINTMENT / OPHTHALMIC	0.05 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	GUM, CHEWING / ORAL		6168 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / AURICULAR (OTIC)	63.64 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS		385 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	SOLUTION/ DROPS / OPHTHALMIC	0.47 %w/v		Exact identifier — unii candidate 19 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SYSTEM / TOPICAL		18144 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	TABLET, CHEWABLE / ORAL	0.14 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / INTRASYNOVIAL	ADJ PH		Exact identifier — unii candidate 88 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION / INTRAVENOUS		33750 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET, FILM COATED / ORAL	5 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	SOLUTION / RECTAL	6.67 %w/v		Exact identifier — unii candidate 19 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	SOLUTION / ORAL		800 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	LOTION / TOPICAL	0.85 %w/w		Exact identifier — unii candidate 88 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
1e66114f-db78-443f-e054-00144ff8d46c			b4630613-c78c-4f97-bd6c-0476899f5b90	2015-08-28	Warnings	Exact identifier spl id: 1e66114f-db78-443f-e054-00144ff8d46c spl set id: b4630613-c78c-4f97-bd6c-0476899f5b90

Reported adverse events (FAERS/openFDA)#

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