Giltuss Childrens MultiSymptom Cold and Flu

Manufacturer
Giltuss Pharmaceutical Corp | Dextrum Laboratories Inc
Effective date
2025-10-09
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:38:34

Label at a glance#

ProductGiltuss Childrens MultiSymptom Cold and Flu
Active ingredientCHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN
Label structure18 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each 5 mL)

Acetaminophen 325 mg

Chlorpheniramine maleate 2 mg

Dextromethorphan HBr 6.5 mg

Phenylephrine HCl 5 mg

OTC - PURPOSE SECTION

Purposes

Pain reliever/fever reducer

Antihistamine

Cough Suppressant

Nasal decongestant

INDICATIONS & USAGE SECTION

Uses

  • temporarily relieves:
  • minor aches and pains
  • headache
  • minor sore throat pain
  • runny nose
  • itchy nose or throat
  • sneezing
  • itchy watery eyes due to hay fever
  • nasal and sinus congestion
  • cough due to minor throat and bronchial irritation as may occur with a cold
  • temporarily reduces fever

WARNINGS SECTION

Warnings

Liver warning:This product contains acetaminophen. Severe liver damage may occur if your child takes:

  • more than 5 doses in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen

Allergy alert:Acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stop use and seek medical help right away.

Sore throat warning:If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

OTC - DO NOT USE SECTION

Do not use

  • in a child under 4 years of age
  • if your child is allergic to acetaminophen or any inactive ingredient in this product
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
  • to make your child sleepy

OTC - ASK DOCTOR SECTION

Ask a doctor or pharmacist before use if the child has

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • glaucoma
  • a breathing problem such as chronic bronchitis
  • cough that occurs with too much phlegm (mucus)
  • chronic cough that lasts such as occurs with asthma

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if the child is

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

OTC - WHEN USING SECTION

When using this product

  • do not exceed recommended dosage
  • marked drowsiness may occur
  • excitability may occur, especially in children

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • nervousness, dizzyness or sleeplessness
  • pain, nasal congestion, or cough gets worse or lasts more than 5 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • cough comes back or occurs with fever, rash or headache that lasts.

These could be signs of a 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 overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

DOSAGE & ADMINISTRATION SECTION

Directions

  • this product does not contain directions or complete warnings for adult use
  • do not give more than directed
  • use enclosed dosing cup
  • keep dosing cup for use with this product
  • mL = milliliter
children under 6 years of ageDo not use
children 6 to under 12 years of age5 mL every 4-6 hours, not to exceed 5 doses in 24 hours
children 12 years and over10 mL every 4-6 hours, not to exceed 6 doses in 24 hours

OTHER SAFETY INFORMATION

Other information

  • store at room temperature 15° - 30°C (59° - 86°F)
  • close cap tightly
  • SAVE CARTON FOR COMPLETE DRUG FACTS

INACTIVE INGREDIENT SECTION

Inactive ingredients

Citric acid, disodium EDTA, flavor, glycerin, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water and sucralose

OTC - QUESTIONS SECTION

Questions or comments?

Call 1-787-848-9114,Monday-Friday 9AM - 5PM EST. Call your doctor for medical advice in the event of side effects.

SPL UNCLASSIFIED SECTION

Tamper evident: do not use if safety seal is broken or missing

MANUFACTURED FOR

GIL PHARMACEUTICAL CORP.

PONCE, PUERTO RICO 00717-1565

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Children's

Giltuss® MULTI-SYMPTOM

COLD & FLU

ANALGESIC, ANTITUSSIVE, ANTIHISTAMINE & NASAL DECONGESTANT

Alcohol Free. Sodium Free. Sugar Free. Dye Free

  • FEVER, HEADACHE AND BODY ACHES
  • COUGH AND COLD
  • STUFFY NOSE
  • SNEEZING AND RUNNY NOSE

STRAWBERRY FLAVOR

4FL OZ (118 mL)

58552-137 Child Multisymptom58552-137 Child Multisymptom

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2121065acetaminophen 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 6.5 MG / phenylephrine HCl 5 MG in 5 mL Oral SolutionPSN6
2121065acetaminophen 65 MG/ML / chlorpheniramine maleate 0.4 MG/ML / dextromethorphan hydrobromide 1.3 MG/ML / phenylephrine hydrochloride 1 MG/ML Oral SolutionSCD6
2121065acetaminophen 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 6.5 MG / phenylephrine hydrochloride 5 MG per 5 ML Oral SolutionSY6
2121065APAP 65 MG/ML / Chlorpheniramine Maleate 0.4 MG/ML / Dextromethorphan Hydrobromide 1.3 MG/ML / Phenylephrine Hydrochloride 1 MG/ML Oral SolutionSY6

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
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
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42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
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e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58552-137-04Giltuss Childrens MultiSymptom Cold and Flu1 in 1 CARTONSOLUTION16
58552-137-04Giltuss Childrens MultiSymptom Cold and Flu118 mL in 1 BOTTLESOLUTION1186

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58552-137-04ML - Milliliter58552-137b46426ad-5928-4f39-afc4-b968ee09579612019-05-02

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58552-13758552-137-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
52024-10-24full-release2026-06-01 00:29:54

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 Childrens MultiSymptom Cold and FluACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEGiltuss Pharmaceutical Corp852c8cd6-271f-0fa8-e053-2991aa0ab1792025-10-09WarningsExact identifier
ndc (package): 58552-137-04
ndc (product): 58552-137
ndc11 (package): 58552013704
spl id: 40b8865e-4141-75bb-e063-6394a90aafba
spl set id: 852c8cd6-271f-0fa8-e053-2991aa0ab179

Reported adverse events (FAERS/openFDA)#

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