Giltuss Allergy Plus

Manufacturer
Dextrum Laboratories Inc.
Effective date
2025-09-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:15:46

Label at a glance#

ProductGiltuss Allergy Plus
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, CHLORPHENIRAMINE MALEATE
Label structure14 sections

Indications and uses

Uses Temporary relieves: Cough due to minor throat and bronchial irritation associated with the common cold or inhaled irritants, helps loosen phlegm ( mucus) and thin bronchial secretions to make cough more productive, temporary relieves nasal congestion due to a cold

Dosage and administration

Directions Do not take more than 6 doses in any 24 hours period use enclosed dosing cup Keep dosage cup for use with this product ml= milliliters Adults and children 12 years & over 10 ml every 4 to 6 hours Children 6 to under 12 years of age 5 ml every 4 to 6 hours Children under 6 years of age Consult a doctor hildren under 6 years of age Consult a doctor

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each 10 m) Purposes

Chlorpheniramine maleate, USP 4 mg -------------------------------Antihistamine

Dextromethorphan HBr, USP 20 mg -----------------------------------Cough supressant

Phenylephrine HCl, USP 10 mg -----------------------------------------Nasal descongestant Active ingredientsActive ingredients

Uses

OTC - PURPOSE SECTION

Uses

Temporary relieves:

Cough due to minor throat and bronchial irritation associated with the common cold or inhaled irritants, UsesUseshelps loosen phlegm ( mucus) and thin bronchial secretions to make cough more productive, temporary relieves nasal congestion due to a cold

Warnings

WARNINGS SECTION

WarningsWarningsWarnings

Do not use

If your child is 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 don’t know is your prescription drug contains and MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have:

heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to an enlarged prostate unless directed by a doctor, a cough with too much phlegm (mucus), a persistent or chronic cough Ask a doctorAsk a doctoras occurs with smoking, asthma, chronic bronchitis, or emphysema

Ak a doctor or pharmacist before use it

OTC - ASK DOCTOR/PHARMACIST SECTION

As a doctor or pharmacist before use if you ar etaking any other oral nasal descongestant or stimulant, sedatives, tranquilizer, and drugs used for depression, especially momoamine oxidase inhibitors ( MAOI) Ask a doctor or pharmacistAsk a doctor or pharmacist

Stop use and ask a doctor if

OTC - STOP USE SECTION

Stop use and ask a doctor if

if you get nervous, dizzy, or sleepless, symptoms do not get better within 7 days or are accompanied by fever, cough lasts more than 7 days, comeback, or is accompanied by fever,rash, or persistent headache

These could be signs of a serious condition. Stop use and ask a doctorStop use and ask a doctor

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast- feeding, ask a health professional before use. Keep out of reach of children. In case of accidental overdose, get medical or professional help or contact a Poisson Control center immediately If pregnancyIf pregnancy

Directions

DOSAGE & ADMINISTRATION SECTION

Directions

Do not take more than 6 doses in any 24 hours period

use enclosed dosing cup

Keep dosage cup for use with this product

ml= milliliters

Adults and children 12 years & over 10 ml every 4 to 6 hours

Children 6 to under 12 years of age 5 ml every 4 to 6 hours

Children under 6 years of age Consult a doctor

DirectionsDirectionshildren under 6 years of age Consult a doctor

Other information

OTHER SAFETY INFORMATION

Other information

Store at room temperature 15-30 °C (59° -86 ° F)
Close cap tightly
SAVE CARTON FOR COMPLETE DRUG FACTS Other informationOther information

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Inactive Ingredients

Citric Acid, flavor, glycerin, methylparaben, propylparaben, purified water and sucralose Inactive ingredientsInactive ingredients

Questions or comments?

OTC - QUESTIONS SECTION

QuestionsQuestionsQuestions or comments?

Call 1-787-848-9114, Monday-Friday 9AM – 5PM EST

Call your doctor for medical advice in the event of side effects.

Indication and usage section

INDICATIONS & USAGE SECTION

indicationindication

Do not take more than 6 doses in any 24 hours period

use enclosed dosing cup

Keep dosage cup for use with this product

ml= milliliters

Adults and children 12 years & over 10 ml every 4 to 6 hours

Children 6 to under 12 years of age 5 ml every 4 to 6 hours

Children under 6 years of age Consult a doctor

keep out of reach of children section

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

keep out of reach of children section

. In case of accidental overdose, get medical or professional help or contact a Poisson Control center immediately

Keep outKeep out

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal panelPrincipal panelMaximum strength

Giltuss Allergy Plus

Cough & Congestion

Alcohol free, Sodium free, sugar free, dye free

Sneezing, runny nose, itchy and watery eyes, cough, stuffy nose, sinus pressure

Tutti Frutti flavor

4 floz 118 ml

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1363752chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG in 5 mL Oral SolutionPSN1
1363752chlorpheniramine maleate 0.4 MG/ML / dextromethorphan hydrobromide 2 MG/ML / phenylephrine hydrochloride 1 MG/ML Oral SolutionSCD1
1363752chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 5 ML Oral SolutionSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CHLORPHENIRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
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e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
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e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65852-017-04Giltuss Allergy Plus118 mL in 1 BOTTLE, PLASTICSOLUTION1181
65852-017-04Giltuss Allergy Plus1 in 1 CARTONSOLUTION11

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65852-01765852-017-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

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
Giltuss Allergy PlusCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEDextrum Laboratories Inc.3fa0b3be-2124-ed1d-e063-6294a90aaf482025-09-25WarningsExact identifier
ndc (package): 65852-017-04
ndc (product): 65852-017
ndc11 (package): 65852001704
spl id: 3fa0b3be-2125-ed1d-e063-6294a90aaf48
spl set id: 3fa0b3be-2124-ed1d-e063-6294a90aaf48

Reported adverse events (FAERS/openFDA)#

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