GILTUSS D ALLERGY AND CONGESTION- chlorpheniramine maleate, phenylephrine hcl tablet

Giltuss D Allergy and Congestion by

Drug Labeling and Warnings

Giltuss D Allergy and Congestion by is a Otc medication manufactured, distributed, or labeled by Gil Pharmaceutical Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients (in each tablet)

Chlorpheniramine Maleate 3.5 mg
Phenylephrine HCl 10 mg

PURPOSE

Purposes
Antihistamine
Nasal Decongestant

INDICATIONS & USAGE

Uses
Temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies:

• runny nose
• sneezing
• itchy, watery eyes
• nasal congestion
• itching of the nose or throat
• sinus congestion and pressure

WARNINGS

Warnings

Do not use if 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.

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

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

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

Stop use and ask a doctor if

• nervousness, dizziness, or sleeplessness occurs
• symptoms do not improve within 7 days or occur with a fever

If pregnant or breast-feeding, ask a health professional before use.

Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

DOSAGE & ADMINISTRATION

Directions

adults and children 12 years and over

• take 1 tablet every 4 hours
• do not take more than 6 tablets in 24 hours
• children 6 to under 12 years of age: take 1/2 tablet every 4 hours, not to exceed 3 tablets in a 24 hour period
• do not use this product for children under 6 years of age

STORAGE AND HANDLING

Other information

• store at room temperature, USP
• do not use if blister seal is broken

INACTIVE INGREDIENT

Inactive ingredients

Magnesium Stearate, Microcrystalline Cellulose and Silica.

QUESTIONS

Questions? Call 787-848-9114

SPL UNCLASSIFIED SECTION

MANUFACTURED FOR GIL PHARMACEUTICAL CORP.

PONCE, PUERTO RICO 00717-1565

giltuss.com

PRINCIPAL DISPLAY PANEL

MAXIMUM STRENGTH

NO PSEUDOEPHEDRINE

Giltuss®-D

ALLERGY & CONGESTION

20 TABLETS

SUGAR FREE. ALCOHOL FREE. DYE FREE. SODIUM FREE

RELIEVES

• SNEEZING
• RUNNY NOSE
• ITCHY, WATERY EYES
• ITCHY THROAT OR NOSE
• SINUS PRESSURE
• STUFFY NOSE

INGREDIENTS AND APPEARANCE

GILTUSS D ALLERGY AND CONGESTION 
chlorpheniramine maleate, phenylephrine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58552-333
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	3.5 mg

Inactive Ingredients
Ingredient Name	Strength
MAGNESIUM STEARATE (UNII: 70097M6I30)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	8mm
Flavor		Imprint Code	GIL;322
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58552-333-20	10 in 1 BOX	11/17/2016
1		2 in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 58552-333-25	25 in 1 CARTON	05/28/2019
2		1 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	11/17/2016

Labeler - Gil Pharmaceutical Corp (176826592)