FDA.reportPublic FDA data

PRESGEN 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 01:16:35

Label at a glance#

ProductPRESGEN PEDIATRIC
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
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    • cough due to minor throat and bronchial irritation

Dosage and administration

 • do not take more than 6 doses in any 24-hour period.  • mL = milliliter  age  dose  Adults and Children 12 years of age and over  4 teaspoons (20 mL) every 4 hours  Children 6 to under 12 years of age  2 teaspoons (10 mL) every 4 hours  Children 2 to under 6 years of age  1 teaspoon (5 mL) every 4 hours  Children under 2 years of age  do not use

Storage and handling

• Tamper evident feature: Do not use if security seal is torn, broken or missing. • Store at controlled room temperature 15-30°C (59-86°F). • Avoid excessive heat and humidity.

Label contents#

Full prescribing information#

Active ingredients (in each 5 mL, 1 teaspoon)

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr, 5 mg
Guaifenesin, 75 mg
Phenylephrine HCl, 2.5 mg

Purposes

OTC - PURPOSE SECTION

Cough Suppressant
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
   • 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 a MAOI, ask a doctor or pharmacist before giving this product.

Ask a doctor before use if you have
• heart disease • high blood pressure • thyroid disease • diabetes • trouble urinating due to an enlarged prostate gland • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema.

When using this product, do not exceed recommended dosage.

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, come 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 accidental 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.
 • mL = milliliter

 age dose
 Adults and Children 12 years of age and over 4 teaspoons (20 mL) every 4 hours
 Children 6 to under 12 years of age 2 teaspoons (10 mL) every 4 hours
 Children 2 to under 6 years of age 1 teaspoon (5 mL) every 4 hours
 Children under 2 years of age do not use

Other information

STORAGE AND HANDLING SECTION

• Tamper evident feature: Do not use if security seal is torn, broken or missing.
• Store at controlled room temperature 15-30°C (59-86°F).
• Avoid excessive heat and humidity.

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid, flavor, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sucralose.

Questions or comments?

OTC - QUESTIONS SECTION

Call weekdays from 8AM to 4 PM AST at 1.787.767.2072

SPL UNCLASSIFIED SECTION

Compare to Tussi-Pres® Pediatric

Dextromethorphan HBr
COUGH SUPPRESSANTGuaifenesin
EXPECTORANTPhenylephrine HCl
NASAL DECONGESTANT

SUGAR AND ALCOHOL FREE
SACCHARIN AND SORBITOL FREE
DYE FREE

ORANGE FLAVOR

KramerNovis
Pharmaceuticals within reach of patients

Manufactured in USA with imported ingredients for Kramer Novis
San Juan, PR 00917
www.kramernovis.com

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRESGEN PEDIATRICPRESGEN PEDIATRIC

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
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
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52083-653-162025-11-18C16284748780-12cef2736-b102-d83d-e063-dadaa90ab31fPRESGEN PEDIATRIC
52083-653-162025-01-30C16284748780-12cef2736-b102-d83d-e063-dadaa90ab31fPRESGEN PEDIATRIC

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52083-653-16PRESGEN PEDIATRIC480 mL in 1 BOTTLESYRUP4806

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52083-653-16ML - Milliliter52083-653ddb3af58-cd6b-4248-aca4-547fb564a1f312012-07-24

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
52083-65352083-653-16

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
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
GUAIFENESIN495W7451VQACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
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 · 10 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
METHYLPARABENMETHYLPARABENA2I8C7HI9TSYRUP / ORAL81 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSYRUP / ORAL40 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYRUP / ORAL16734 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSYRUP / ORAL40 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSYRUP / ORAL722 mg/5mlExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SYRUP / ORAL5700 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SYRUP / ORAL5700 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSYRUP / ORAL722 mg/5mlExact identifier — unii+route+dosage form
2 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSYRUP / ORAL81 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYRUP / ORAL16734 mgExact identifier — unii+route+dosage form
2 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
PRESGEN PEDIATRICGUAIFENESIN, PHENYLEPHRINE HCL,DEXTROMETHORPHAN HYDROBROMIDEKRAMER NOVIS12fb91e5-6059-4b3a-a2de-762aa51a25b72025-11-12WarningsExact identifier
ndc (package): 52083-653-16
ndc (product): 52083-653
ndc11 (package): 52083065316
spl id: 6fa9d05a-47dd-4ede-b77b-ada155683617
spl set id: 12fb91e5-6059-4b3a-a2de-762aa51a25b7

Reported adverse events (FAERS/openFDA)#

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