FDA.reportPublic FDA data

TUSSI PRES PEDIATRIC

Manufacturer
KRAMER NOVIS
Effective date
2025-11-12
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:16:13

Label at a glance#

ProductTUSSI PRES PEDIATRIC
Active ingredientGUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE
Label structure10 sections

Indications and uses

• Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes.  • Temporarily relieves these symptoms occurring with a cold: nasal congestion and cough due to minor throat and bronchial irritation.

Dosage and administration

Do not take more than 6 doses in any 24-hour period.  Adults & Children 12 years of age and older  Take 4 teaspoons (20 mL) every 4 hours, as needed.  Children 6 to under 12 years of age  Take 2 teaspoons (10 mL) every 4 hours, as needed.  Children 2 to under 6  Take one pre-measured single dose package (1 teaspoon or 5 mL) every 4 hours, as needed.  Children under 2 years  Do not use.

Storage and handling

• Tamper Evident. Do not use if packet is torn, cut or opened. • Store at controlled room temperature 15° to 30°C (59° to 86°F). • Avoid excessive heat or humidity.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients (In each 5 mL teaspoon)

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr 5 mg

Guaifenesin 75 mg

Phenylephrine HCl 2.5 mg

Purpose

OTC - PURPOSE SECTION

Antitussive (Anti-Cough)

Expectorant

Nasal Decongestant

Uses:

INDICATIONS & USAGE SECTION

• Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes. 

• Temporarily relieves these symptoms occurring with a cold: nasal congestion and cough due to minor throat and bronchial irritation.

Warnings:

WARNINGS SECTION

Do not use: • in a child under 2 years of age. • in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if your child has:

• heart disease • high blood pressure • thyroid disease • diabetes • trouble urinating due to an enlarged prostate gland • cough that occurs with too much phlegm (mucus), or cough that lasts or is chronic such as occurs with asthma, chronic bronchitis or emphysema.

Do not use more than the recommended dose.

Stop use and ask a doctor if: • your child gets nervous, dizzy or sleepless • symptoms do not get better within 7 days or are accompanied by fever • cough lasts more than 7 days, comes back, or is accompanied by fever, rash or persistent headache. These could be signs of a serious condition.

If pregnant or breast-feeding, ask a health professional before use.

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.

Directions:

DOSAGE & ADMINISTRATION SECTION

Do not take more than 6 doses in any 24-hour period.

 Adults & Children 12 years of age and older Take 4 teaspoons (20 mL) every 4 hours, as needed.
 Children 6 to under 12 years of age Take 2 teaspoons (10 mL) every 4 hours, as needed.
 Children 2 to under 6 Take one pre-measured single dose package (1 teaspoon or 5 mL) every 4 hours, as needed.
 Children under 2 years Do not use.

Other Information:

STORAGE AND HANDLING SECTION

• Tamper Evident. Do not use if packet is torn, cut or opened.

• Store at controlled room temperature 15° to 30°C (59° to 86°F).

• Avoid excessive heat or humidity.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Citric acid, Flavor, Glycerin, Methylparaben, Propylene glycol, Propylparaben, Purified water, Sodium citrate and Sucralose

SPL UNCLASSIFIED SECTION

COUGH SUPPRESSANT, EXPECTORANT, NASAL DECONGESTANT

SUGAR, ALCOHOL, SACCHARIN, SORBITOL & DYE FREE

ORANGE FLAVOR

Manufactured in the USA for: Kramer Novis, San Juan, PR 00917.

1 (787) 767-2072 www.kramernovis.com

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TUSSIPRESPEDIATRICTUSSIPRESPEDIATRIC

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1119541dextromethorphan HBr 5 MG / guaiFENesin 75 MG / phenylephrine HCl 2.5 MG in 5 mL Oral SolutionPSN6
1119541dextromethorphan hydrobromide 1 MG/ML / guaifenesin 15 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral SolutionSCD6
1119541dextromethorphan hydrobromide 5 MG / guaifenesin 75 MG / phenylephrine hydrochloride 2.5 MG per 5 ML Oral SolutionSY6

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130352083232169GTIN-13: 0352083232169
EAN-13: 0352083232169
GTIN-12: 352083232169
UPC-A: 352083232169
GTIN storage (14 digits): 00352083232169		52083232-1.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52083-232-012025-11-14C16284748780-12cef2736-6053-d83d-e063-dadaa90ab31fTUSSI PRES PEDIATRIC
52083-232-042025-11-14C16284748780-12cef2736-6053-d83d-e063-dadaa90ab31fTUSSI PRES PEDIATRIC
52083-232-052025-11-14C16284748780-12cef2736-6053-d83d-e063-dadaa90ab31fTUSSI PRES PEDIATRIC
52083-232-162025-11-14C16284748780-12cef2736-6053-d83d-e063-dadaa90ab31fTUSSI PRES PEDIATRIC
52083-232-012025-01-30C16284748780-12cef2736-6053-d83d-e063-dadaa90ab31fTUSSI PRES PEDIATRIC
52083-232-042025-01-30C16284748780-12cef2736-6053-d83d-e063-dadaa90ab31fTUSSI PRES PEDIATRIC
52083-232-052025-01-30C16284748780-12cef2736-6053-d83d-e063-dadaa90ab31fTUSSI PRES PEDIATRIC
52083-232-162025-01-30C16284748780-12cef2736-6053-d83d-e063-dadaa90ab31fTUSSI PRES PEDIATRIC

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52083-232-01TUSSI PRES PEDIATRIC30 mL in 1 BOTTLESYRUP306
52083-232-04TUSSI PRES PEDIATRIC120 mL in 1 BOTTLESYRUP1206
52083-232-05TUSSI PRES PEDIATRIC5 mL in 1 BOTTLESYRUP56
52083-232-16TUSSI PRES PEDIATRIC480 mL in 1 BOTTLESYRUP4806

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52083-232-04ML - Milliliter52083-23206ef9126-dc33-47c2-b09e-ea509f104b4712013-02-13
52083-232-05ML - Milliliter52083-232c20a5746-f081-4a2d-a499-6aabc63ffadf12018-12-13
52083-232-16ML - Milliliter52083-23265b6b6cc-9223-4f33-b2e9-4ef90823c2c912013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYH1
GUAIFENESINACTIVE INGREDIENT495W7451VQ1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJ1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTS1
GUAIFENESINACTIVE MOIETY495W7451VQ1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MV1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QP1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V31
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OH1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULR1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52083-23252083-232-01, 52083-232-04, 52083-232-16, 52083-232-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
GUAIFENESIN495W7451VQACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
GLYCERINPDC6A3C0OXIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
SUCRALOSE96K6UQ3ZD4IACT

Source Document#

Source XML · Source PDF

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 1 · 25 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
GLYCERINGLYCERINPDC6A3C0OXSYRUP / ORAL16734 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSYRUP / ORAL722 mg/5mlExact identifier — unii+route+dosage form
5 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYRUP / ORAL16734 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSYRUP / ORAL40 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYRUP / ORAL16734 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYRUP / ORAL16734 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSYRUP / ORAL40 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSYRUP / ORAL81 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSYRUP / ORAL40 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SYRUP / ORAL5700 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSYRUP / ORAL81 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SYRUP / ORAL5700 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SYRUP / ORAL5700 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSYRUP / ORAL40 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSYRUP / ORAL722 mg/5mlExact identifier — unii+route+dosage form
5 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SYRUP / ORAL5700 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSYRUP / ORAL81 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSYRUP / ORAL81 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYRUP / ORAL16734 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSYRUP / ORAL722 mg/5mlExact identifier — unii+route+dosage form
5 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SYRUP / ORAL5700 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSYRUP / ORAL722 mg/5mlExact identifier — unii+route+dosage form
5 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSYRUP / ORAL722 mg/5mlExact identifier — unii+route+dosage form
5 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSYRUP / ORAL81 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSYRUP / ORAL40 mgExact identifier — unii+route+dosage form
5 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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TUSSI PRES PEDIATRICGUAIFENESIN, PHENYLEPHRINE HCL,DEXTROMETHORPHAN HYDROBROMIDEKRAMER NOVISb01a45df-3cea-4729-80c1-7f35b7f707f02025-11-12WarningsExact identifier
ndc (package): 52083-232-05
ndc (package): 52083-232-01
ndc (package): 52083-232-04
ndc (package): 52083-232-16
ndc (product): 52083-232
ndc11 (package): 52083023205
ndc11 (package): 52083023204
ndc11 (package): 52083023201
ndc11 (package): 52083023216
spl id: e67f6230-a612-4351-b907-a759020a3bda
spl set id: b01a45df-3cea-4729-80c1-7f35b7f707f0

Reported adverse events (FAERS/openFDA)#

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