Tusnel

Manufacturer: Llorens Pharmaceutical International Division
Effective date: 2025-12-31
Label type: HUMAN OTC DRUG LABEL
Version: 9
Source: full-release
Hydrated at: 2026-06-01 01:30:23

Label at a glance#

ProductTusnel Pediatric

Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE

Label structure10 sections

Contacts and useful links#

PhoneLabel contact1-866-595-5598

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients(in each 5 ml tsp.) Purpose

Dextromethorphan HBr........5mg..................................................Cough Suppressant

Guaifenesin........................50mg................................................Expectorant

Pseudoephedrine HCl..........15mg..................................................Nasal Decongestant

OTC - PURPOSE SECTION

Purpose

Cough Suppressant

Expectorant

Nasal Decongestant

WARNINGS SECTION

Warnings
Do not useif 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.

OTC - DO NOT USE SECTION

Ask a doctor before use if your child has

heart disease
high blood pressure
thyroid disease
diabetes
a cough that occurs with too much phlegm (mucus)
a persistent or chronic cough such as occurs with asthma

When using this product

do not exceed recommended dosage

Stop use and ask a doctor if

nervousness, dizziness or sleeplessness occurs
symptoms do not get better within 7 days or accompanied by fever
cough last more than 7 days, comes back, or is accompanied by fever, rash or persistent headache. A persistent cough could be a sign of a serious condition.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

DirectionsDo not exceed more than 4 doses in any 24-hour period
or as directed by a doctor.

Age	Weight	Dose
Children 6 to under 12 years of age	45 lbs to under 95 lbs	Take 2 teaspoonfuls (10 mL) every 4 to 6 hours
Children 2 to under 6 years of age	25 lbs to under 45 lbs	Take 1 teaspoonful (5mL) every 4 to 6 hours
Children under 2 years of age	Under 25 lbs	ask a doctor

INDICATIONS & USAGE SECTION

Uses

helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
temporarily relieves these symptoms occurring with a cold: nasal congestions, cough due to minor throat and bronchial irritation.

INACTIVE INGREDIENT SECTION

Inactive ingredients astificial and natural flavor, citric acid, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, and sucralos

OTC - QUESTIONS SECTION

Questions or Comments?1-866-595-5598

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

tusnelpediatriclabel

RxCUI, Display, Full name table
RxCUI	Display	Full name	Type	Form / route
1098911	Dextromethorphan/guaiFENesin/Pseudoephedrine (Oral Liquid)	dextromethorphan hydrobromide 1 MG/ML / guaifenesin 10 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
1098911	dextromethorphan HBr 5 MG / guaiFENesin 50 MG / pseudoephedrine HCl 15 MG in 5 mL Oral Solution	PSN	9
1098911	dextromethorphan hydrobromide 1 MG/ML / guaifenesin 10 MG/ML / pseudoephedrine hydrochloride 3 MG/ML Oral Solution	SCD	9
1098911	dextromethorphan HBr 5 MG / guaifenesin 50 MG / pseudoephedrine HCl 15 MG per 5 ML Oral Solution	SY	9

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

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	EAN-13	0054859544161	GTIN-13: 0054859544161 EAN-13: 0054859544161 GTIN-12: 054859544161 UPC-A: 054859544161 GTIN storage (14 digits): 00054859544161	TusnelPediatricLiq.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
bf324df6-7127-7deb-def5-2681c136cd03	Product name	3	20250325
43a1ed49-eae2-4840-8075-cb4b33478540	Product name	1	20230425
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
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
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
76633df9-0d59-4b88-03ed-21dee1b966f8	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
54859-544-04	2020-12-23	C162847	48780-1	9d75b9d0-9565-f424-e053-dadaa90a57ce	Llorens-Tusnel Ped 544
54859-544-16	2020-12-23	C162847	48780-1	9d75b9d0-9565-f424-e053-dadaa90a57ce	Llorens-Tusnel Ped 544
54859-544-04	2020-01-31	C162847	48780-1	9d75b9d0-9565-f424-e053-dadaa90a57ce	Llorens-Tusnel Ped 544
54859-544-16	2020-01-31	C162847	48780-1	9d75b9d0-9565-f424-e053-dadaa90a57ce	Llorens-Tusnel Ped 544

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
54859-544-04	TusnelPediatric	118 mL in 1 BOTTLE	LIQUID	118		9
54859-544-16	TusnelPediatric	473 mL in 1 BOTTLE	LIQUID	473		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
54859-544-04	ML - Milliliter	54859-544	d7f3d47e-5961-483e-b7c9-04be86cf7999	1	2012-07-24
54859-544-16	ML - Milliliter	54859-544	1c52ee16-f421-4855-926f-e9a37cd6ed41	1	2025-05-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	2
Guaifenesin	ACTIVE INGREDIENT	495W7451VQ	2
PSEUDOEPHEDRINE HYDROCHLORIDE	ACTIVE INGREDIENT	6V9V2RYJ8N	2
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	2
Guaifenesin	ACTIVE MOIETY	495W7451VQ	2
PSEUDOEPHEDRINE	ACTIVE MOIETY	7CUC9DDI9F	2
ASPARTAME	INACTIVE INGREDIENT	Z0H242BBR1	2
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	2
CORN SYRUP	INACTIVE INGREDIENT	9G5L16BK6N	2
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	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
WATER	INACTIVE INGREDIENT	059QF0KO0R	2

Products#

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

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

Tusnel Pediatric
Dextromethorphan, Guiafenesin, Pseudoephedrine HCl
CITRIC ACID MONOHYDRATE
METHYLPARABEN
PROPYLENE GLYCOL
PROPYLPARABEN
WATER
SODIUM CITRATE
SUCRALOSE
DEXTROMETHORPHAN HYDROBROMIDE
DEXTROMETHORPHAN
GUAIFENESIN
PSEUDOEPHEDRINE HYDROCHLORIDE
PSEUDOEPHEDRINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
54859-544	54859-544-04, 54859-544-16

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
CITRIC ACID MONOHYDRATE	2968PHW8QP	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
WATER	059QF0KO0R	IACT
SODIUM CITRATE	1Q73Q2JULR	IACT
SUCRALOSE	96K6UQ3ZD4	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 3 · 171 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
D&C RED NO. 33	D&C RED NO. 33	9DBA0SBB0L	SYRUP / ORAL		1 mg	Exact identifier — unii+route 36 equally ranked IID candidates
CORN SYRUP	CORN SYRUP	9G5L16BK6N	ELIXIR / ORAL	400 mg/1ml		Exact identifier — unii+route 27 equally ranked IID candidates
D&C RED NO. 33	D&C RED NO. 33	9DBA0SBB0L	CAPSULE, LIQUID FILLED / ORAL	0.01 mg		Exact identifier — unii+route 36 equally ranked IID candidates
CORN SYRUP	CORN SYRUP	9G5L16BK6N	SUSPENSION, EXTENDED RELEASE / ORAL	1500 mg/5ml		Exact identifier — unii+route 27 equally ranked IID candidates
ASPARTAME	ASPARTAME	Z0H242BBR1	SYRUP / ORAL	0.63 mg/5ml		Exact identifier — unii+route 51 equally ranked IID candidates
POTASSIUM CITRATE	POTASSIUM CITRATE	EE90ONI6FF	SOLUTION / ORAL		913 mg	Exact identifier — unii+route 9 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	POWDER, FOR SUSPENSION / ORAL		19 mg	Exact identifier — unii+route 36 equally ranked IID candidates
D&C RED NO. 33	D&C RED NO. 33	9DBA0SBB0L	CONCENTRATE / ORAL	0.02 mg/1ml		Exact identifier — unii+route 36 equally ranked IID candidates
ASPARTAME	ASPARTAME	Z0H242BBR1	TABLET, ORALLY DISINTEGRATING / ORAL		180 mg	Exact identifier — unii+route 51 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	LIQUID / ORAL		29008 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
CORN SYRUP	CORN SYRUP	9G5L16BK6N	TROCHE / ORAL	NA		Exact identifier — unii+route 27 equally ranked IID candidates
D&C RED NO. 33	D&C RED NO. 33	9DBA0SBB0L	TABLET / ORAL	0.24 mg		Exact identifier — unii+route 36 equally ranked IID candidates
ASPARTAME	ASPARTAME	Z0H242BBR1	POWDER, FOR SUSPENSION / ORAL		420 mg	Exact identifier — unii+route 51 equally ranked IID candidates
ASPARTAME	ASPARTAME	Z0H242BBR1	CAPSULE, EXTENDED RELEASE / ORAL		3 mg	Exact identifier — unii+route 51 equally ranked IID candidates
POTASSIUM CITRATE	POTASSIUM CITRATE	EE90ONI6FF	SUSPENSION / ORAL	NA		Exact identifier — unii+route 9 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	GRANULE, FOR SUSPENSION / ORAL		80 mg	Exact identifier — unii+route 36 equally ranked IID candidates
ASPARTAME	ASPARTAME	Z0H242BBR1	POWDER, FOR SOLUTION / ORAL	233 mg		Exact identifier — unii+route 51 equally ranked IID candidates
ASPARTAME	ASPARTAME	Z0H242BBR1	TABLET, FILM COATED / ORAL		20 mg	Exact identifier — unii+route 51 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	SUSPENSION / ORAL		400 mg	Exact identifier — unii+route 36 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	TABLET, EXTENDED RELEASE / ORAL	0.2 mg		Exact identifier — unii+route 36 equally ranked IID candidates
ASPARTAME	ASPARTAME	Z0H242BBR1	TABLET, CHEWABLE / ORAL		195 mg	Exact identifier — unii+route 51 equally ranked IID candidates
CORN SYRUP	CORN SYRUP	9G5L16BK6N	CAPSULE, EXTENDED RELEASE / ORAL	28.5 mg		Exact identifier — unii+route 27 equally ranked IID candidates
ASPARTAME	ASPARTAME	Z0H242BBR1	GRANULE, FOR SUSPENSION / ORAL		420 mg	Exact identifier — unii+route 51 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	TABLET, EXTENDED RELEASE / ORAL	0.2 mg		Exact identifier — unii+route 36 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	PASTE / ORAL		48 mg	Exact identifier — unii+route 36 equally ranked IID candidates
D&C RED NO. 33	D&C RED NO. 33	9DBA0SBB0L	CONCENTRATE / ORAL	0.02 mg/1ml		Exact identifier — unii+route 36 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	LIQUID / ORAL		2 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
D&C RED NO. 33	D&C RED NO. 33	9DBA0SBB0L	SYRUP / ORAL		1 mg	Exact identifier — unii+route 36 equally ranked IID candidates
CORN SYRUP	CORN SYRUP	9G5L16BK6N	TROCHE / ORAL	NA		Exact identifier — unii+route 27 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	CAPSULE / ORAL	NA		Exact identifier — unii+route 36 equally ranked IID candidates
CORN SYRUP	CORN SYRUP	9G5L16BK6N	SUSPENSION / ORAL	2500 mg/5ml		Exact identifier — unii+route 27 equally ranked IID candidates
D&C RED NO. 33	D&C RED NO. 33	9DBA0SBB0L	TABLET, FILM COATED / ORAL	NA		Exact identifier — unii+route 36 equally ranked IID candidates
CORN SYRUP	CORN SYRUP	9G5L16BK6N	SYRUP / ORAL	600 mg		Exact identifier — unii+route 27 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	LIQUID / ORAL		114 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	CONCENTRATE / ORAL		1 mg	Exact identifier — unii+route 36 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	SYRUP / ORAL	2 mg/1ml		Exact identifier — unii+route 36 equally ranked IID candidates
ASPARTAME	ASPARTAME	Z0H242BBR1	SOLUTION / ORAL		40 mg	Exact identifier — unii+route 51 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	SOLUTION / ORAL	1000 mg/15ml		Exact identifier — unii+route 36 equally ranked IID candidates
CORN SYRUP	CORN SYRUP	9G5L16BK6N	TROCHE / ORAL	NA		Exact identifier — unii+route 27 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	LIQUID / ORAL		29008 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	TABLET, COATED / ORAL	NA		Exact identifier — unii+route 36 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	SUSPENSION / ORAL		400 mg	Exact identifier — unii+route 36 equally ranked IID candidates
D&C RED NO. 33	D&C RED NO. 33	9DBA0SBB0L	CONCENTRATE / ORAL	0.02 mg/1ml		Exact identifier — unii+route 36 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	LIQUID / ORAL		162 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
D&C RED NO. 33	D&C RED NO. 33	9DBA0SBB0L	SOLUTION / ORAL		2 mg	Exact identifier — unii+route 36 equally ranked IID candidates
CORN SYRUP	CORN SYRUP	9G5L16BK6N	SOLUTION / ORAL	750 mg/5ml		Exact identifier — unii+route 27 equally ranked IID candidates
ASPARTAME	ASPARTAME	Z0H242BBR1	SYRUP / ORAL	0.63 mg/5ml		Exact identifier — unii+route 51 equally ranked IID candidates
ASPARTAME	ASPARTAME	Z0H242BBR1	POWDER, FOR SUSPENSION / ORAL		420 mg	Exact identifier — unii+route 51 equally ranked IID candidates
POTASSIUM CITRATE	POTASSIUM CITRATE	EE90ONI6FF	POWDER, FOR SOLUTION / ORAL		570 mg	Exact identifier — unii+route 9 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	PASTE / ORAL		48 mg	Exact identifier — unii+route 36 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	TABLET / ORAL		6 mg	Exact identifier — unii+route 36 equally ranked IID candidates
D&C RED NO. 33	D&C RED NO. 33	9DBA0SBB0L	TABLET / ORAL	0.24 mg		Exact identifier — unii+route 36 equally ranked IID candidates
POTASSIUM CITRATE	POTASSIUM CITRATE	EE90ONI6FF	SOLUTION / ORAL		913 mg	Exact identifier — unii+route 9 equally ranked IID candidates
ASPARTAME	ASPARTAME	Z0H242BBR1	GRANULE, EFFERVESCENT / ORAL	30 mg		Exact identifier — unii+route 51 equally ranked IID candidates
D&C RED NO. 33	D&C RED NO. 33	9DBA0SBB0L	CAPSULE, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii+route 36 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	TABLET / ORAL		6 mg	Exact identifier — unii+route 36 equally ranked IID candidates
D&C RED NO. 33	D&C RED NO. 33	9DBA0SBB0L	TABLET, COATED / ORAL	NA		Exact identifier — unii+route 36 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	CAPSULE / ORAL	NA		Exact identifier — unii+route 36 equally ranked IID candidates
CORN SYRUP	CORN SYRUP	9G5L16BK6N	SOLUTION / ORAL	750 mg/5ml		Exact identifier — unii+route 27 equally ranked IID candidates
D&C RED NO. 33	D&C RED NO. 33	9DBA0SBB0L	SUSPENSION, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii+route 36 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
Tusnel Pediatric	DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL	Llorens Pharmaceutical International Division	82f447f6-4f1b-4f56-9d7d-ea02adeea88c	2025-12-31	Warnings	Exact identifier ndc (package): 54859-544-16 ndc (package): 54859-544-04 ndc (product): 54859-544 ndc11 (package): 54859054404 ndc11 (package): 54859054416 spl id: 47461ad3-a121-2a11-e063-6294a90a0f8f spl set id: 82f447f6-4f1b-4f56-9d7d-ea02adeea88c

Reported adverse events (FAERS/openFDA)#

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