GILTUSS ALLERGY PLUS- chlophedianol hcl, chlorpheniramine maleate, phenylephrine hcl tablet

Giltuss Allergy Plus by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients (in each tablet)

Chlophedianol HCl 24 mg

Chlorpheniramine Maleate 3.5 mg

Phenylephrine HCl 10 mg

PURPOSE

Purposes

Cough Suppressant

Antihistamine

Nasal Decongestant

INDICATIONS & USAGE

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

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
• persistent or chronic cough such as occurs with smoking, asthma
• chronic bronchitis, or emphysema
• excessive phlegm (mucus)

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
• cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache

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

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

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

Other information

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

INACTIVE INGREDIENT

Inactive Ingredients

Croscarmellose Sodium, Magnesium Stearate, Microcrystalline Cellulose and Silica.

QUESTIONS

Questions? Call 787-848-9114

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

INGREDIENTS AND APPEARANCE

GILTUSS ALLERGY PLUS 
chlophedianol hcl, chlorpheniramine maleate, phenylephrine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58552-334
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
CHLOPHEDIANOL HYDROCHLORIDE (UNII: 69QQ58998Y) (CHLOPHEDIANOL - UNII:42C50P12AP)	CHLOPHEDIANOL HYDROCHLORIDE	24 mg

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	8mm
Flavor		Imprint Code	GIL;323
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58552-334-20	10 in 1 BOX	06/22/2018
1		2 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	06/22/2018

Labeler - Gil Pharmaceutical Corp (176826592)