FDA.reportPublic FDA data

Altipres Pediatric

Manufacturer
Advanced Generic Corporation
Effective date
2025-12-30
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:29:06

Label at a glance#

ProductAltipres Pediatric
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients (in each 5 mL tsp.) Purpose

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

Guaifenesin .............................. 75 mg ................ Expectorant

Phenylephrine HCl ..................... 2.5 mg ................... Nasal Decongestant

OTC - PURPOSE SECTION

Purpose

Cough Suppressant

Expectorant

Nasal Decongestant

INDICATIONS & USAGE SECTION

Uses

  • temporarily relieves cough due to minor throat and bronchial irritations as may occur with the common cold
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
  • temporarily releives nasal congestion due to the common cold.

WARNINGS SECTION

Warnings

Do not use 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 your 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 enlargement of prostate gland
  • a cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chrinic 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 for more than 7 days, comes back or is accompanied with a fever, rash or persistent headache. These could be signs of serious condition.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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.

DOSAGE & ADMINISTRATION SECTION

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

AgeDose
Adults and children 12 years of age and overtake 4 teaspoonfuls (20 mL) every 4 hours
Children 6 to under 12 years of agetake 2 teaspoonfuls (10 mL) every 4 hours
Children 2 to under 6 years of agetake 1 teaspoonfuls (5 mL) every 4 hours
Children under 2 years of agedo not use

INACTIVE INGREDIENT SECTION

Inactive ingredients:Artificial and natural flavors, Citric acid, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, and sucralose

OTC - QUESTIONS SECTION

Questions or comments?1-305-403-3788

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AltipresPed105AltipresPed105

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 SolutionPSN3
1119541dextromethorphan hydrobromide 1 MG/ML / guaifenesin 15 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral SolutionSCD3
1119541dextromethorphan hydrobromide 5 MG / guaifenesin 75 MG / phenylephrine hydrochloride 2.5 MG per 5 ML Oral SolutionSY3

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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45737-105-16Altipres Pediatric473 mL in 1 BOTTLELIQUID4733

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45737-105-16ML - Milliliter45737-105ce94ef8c-777b-4e5c-8500-b1bf7911cd9c12025-07-08

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
45737-10545737-105-16

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
SUCRALOSE96K6UQ3ZD4IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
METHYLPARABENA2I8C7HI9TIACT
GLYCERINPDC6A3C0OXIACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
SODIUM CITRATE1Q73Q2JULRIACT
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
GUAIFENESIN495W7451VQACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
PROPYLENE GLYCOL6DC9Q167V3IACT

Source Document#

Source XML

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
Altipres PediatricDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLAdvanced Generic Corporation2a336896-a2f8-2a0c-e063-6294a90ae03a2025-12-30WarningsExact identifier
ndc (package): 45737-105-16
ndc (product): 45737-105
ndc11 (package): 45737010516
spl id: 472eca54-1c0a-770e-e063-6294a90a7e01
spl set id: 2a336896-a2f8-2a0c-e063-6294a90ae03a

Reported adverse events (FAERS/openFDA)#

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