FDA.reportPublic FDA data

Giltuss Allergy Plus - Gil Pharmaceutical Corp

Manufacturer
Gil Pharmaceutical Corp
Effective date
2026-07-23
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
daily-update
Hydrated at
2026-07-28 05:10:08

Label at a glance#

ProductGiltuss Allergy Plus
Active ingredientPHENYLEPHRINE HYDROCHLORIDE, CHLORPHENIRAMINE MALEATE, CHLOPHEDIANOL HYDROCHLORIDE
Label structure9 sections

Storage and handling

Other information store at room temperature, USP do not use if pouch is open or torn

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients (in each tablet)

Chlophedianol HCl 24 mg

Chlorpheniramine Maleate 3.5 mg

Phenylephrine HCl 10 mg

OTC - PURPOSE SECTION

Purposes

Cough Suppressant

Antihistamine

Nasal Decongestant

INDICATIONS & USAGE SECTION

Uses

Temporarily relieves runny nose, sneezing, and itchy and watery eyes due to hay fever or other upper respiratory allergies. Temporarily relieves nasal congestion due to the common cold. Temporarily controls cough due to minor bronchial irritation occurring with the common cold.

WARNINGS SECTION

Warnings

OTC - DO NOT USE SECTION

Do not useif you are 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 do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have:

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • persistent or chronic cough such as occurs with smoking, asthma
  • chronic bronchitis, or emphysema
  • excessive phlegm (mucus)

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

OTC - WHEN USING SECTION

When using this product:

  • do not exceed recommended dose
  • excitability may occur, especially in children
  • drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery

OTC - STOP USE SECTION

Stop use and ask a doctor if:

  • nervousness, dizziness, or sleeplessness occurs
  • symptoms do not improve within 7 days or occur with a fever
  • cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache

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 (1-800-222-1222).

DOSAGE & ADMINISTRATION SECTION

Directions

  • Adults and Children 12 years and over:Take 1 tablet every 6-8 hours. Do not take more than 4 tablets in a 24-hour period.
  • Children 6 to 12 years of age:Take 1/2 tablet every 6-8 hours. Do not take more than 2 tablets in a 24-hour period.
  • Children under 6 years: Consult a physician.

STORAGE AND HANDLING SECTION

Other information

  • store at room temperature, USP
  • do not use if pouch is open or torn

INACTIVE INGREDIENT SECTION

Inactive Ingredients

Croscarmellose Sodium, Magnesium Stearate, Microcrystalline Cellulose and Silica.

OTC - QUESTIONS SECTION

Questions? Call 787-848-9114

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MAXIMUM STRENGTH

Giltuss® ALLERGY PLUS

COUGH & CONGESTION

20 TABLETS

SUGAR FREE. DYE FREE. PRESERVATIVE FREE.

Relieves

  • Sneezing
  • Runny Nose
  • Itchy & watery eyes
  • Double acting cough supressant
  • Stuffy Nose
  • Sinus Pressure

58552-334 Allergy Plus Tabs 6-26-201858552-334 Allergy Plus Tabs 6-26-2018

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
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58552-334-20EA - Each58552-3340bd033eb-0685-492e-bc5d-585aed9a613c12019-05-02

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58552-33458552-334-20

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
CHLORPHENIRAMINE MALEATEV1Q0O9OJ9ZACTIB
CHLOPHEDIANOL HYDROCHLORIDE69QQ58998YACTIB
SILICON DIOXIDEETJ7Z6XBU4IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
MAGNESIUM STEARATE70097M6I30IACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
72025-10-09full-release2026-06-01 01:38:35
62025-03-10full-release2026-06-01 00:57:05

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 PlusCHLOPHEDIANOL HCL, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLGil Pharmaceutical Corp85a0dc7f-ffb5-7d52-e053-2991aa0a602a2026-07-23WarningsExact identifier
ndc (package): 58552-334-20
ndc (product): 58552-334
ndc11 (package): 58552033420
spl id: 5746a65e-86da-77cd-e063-6394a90aefc7
spl set id: 85a0dc7f-ffb5-7d52-e053-2991aa0a602a

Reported adverse events (FAERS/openFDA)#

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