GILTUSS ALLERGY PLUS COUGH AND CONGESTION- chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride solution

Giltuss Allergy Plus by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each 10 mL)

Chlorpheniramine maleate, USP 4 mg

Dextromethorphan HBr, USP 20 mg

Phenylephrine HCl, USP 10 mg

PURPOSE

Purposes

Antihistamine

Cough suppressant

Nasal decongestant

INDICATIONS & USAGE

Uses

• temporarily relieves
• cough due to minor throat and bronchial irritation associated with a cold or inhaled irritants
• nasal congestion due to the common cold, hay fever or other upper respiratory allergies
• temporarily relieves these symptoms due to hay fever (allergic rhinitis):
• runny nose
• sneezing
• itchy, watery eyes
• itching of the nose or throat
• temporarily restores freer breathing through the nose

WARNINGS

Warnings

Do not use

• to sedate a child or to make a child sleepy
• 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 enlargement of the prostate gland
• glaucoma
• cough that occurs with too much phlegm (mucus)
• a breathing problem or persistent or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis or emphysema

Ask a doctor or pharmacist before use if you are

• taking sedatives or tranquilizers
• taking any other oral nasal decongestant or stimulant

When using this product

• do not use more than directed
• may cause marked drowsiness
• avoid alcoholic beverages
• alcohol, sedatives and tranquilizers may increase drowsiness effect
• be careful when driving a motor vehicle or operating machinery
• excitability may occur, especially in children

Stop use and ask a doctor if

• you get nervous, dizzy, or sleepless
• symptoms do not get better within 7 days or are accompanied by a fever
• cough lasts more than 7 days, comes back, or is accompanied by fever, rash or persistent headache.

These could be signs of a serious condition.

If pregnant or breastfeeding,ask a health professional before use.

Keep out of reach of children. In case of overdose, seek professional help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

• Do not take more than 6 doses in any 24-hour period
• use enclosed dosing cup
• keep dosage cup for use with this product
• mL=milliter

• adults and children 12 years and over: 10 mL every 4 to 6 hours
• children 6 to under 12 years: 5 mL every 4 to 6 hours
• children under 6 years: Consult a Doctor

STORAGE AND HANDLING

Other information

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

INACTIVE INGREDIENT

Inactive ingredients

citric acid, flavor, glycerin, methylparaben, propylparaben, purified water and sucralose

QUESTIONS

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.

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

MANUFACTURED FOR

GIL PHARMACEUTICAL CORP.

PONCE, PUERTO RICO 00717-1565

giltuss.com

PRINCIPAL DISPLAY PANEL

MAXIMUM STRENGTH

Giltuss® ALLERGY PLUS COUGH & CONGESTION

ANTIHISTAMINIC, ANTITUSSIVE, & NASAL DECONGESTANT

ALCOHOL FREE. SODIUM FREE. SUGAR FREE. DYE FREE.

RELIEVES

• SNEEZING
• RUNNY NOSE
• ITCHY AND WATERY EYES
• COUGH
• STUFFY NOSE
• SINUS PRESSURE

TUTTI FRUTTI FLAVOR

4FL OZ (118 mL)

INGREDIENTS AND APPEARANCE

GILTUSS ALLERGY PLUS  COUGH AND CONGESTION
chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58552-138
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	4 mg  in 10 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg  in 10 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
PROPYLPARABEN (UNII: Z8IX2SC1OH)
METHYLPARABEN (UNII: A2I8C7HI9T)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	yellow (Light yellow)	Score
Shape		Size
Flavor	TUTTI FRUTTI	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58552-138-04	1 in 1 CARTON	10/02/2018
1		118 mL in 1 BOTTLE; 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	10/02/2018

Labeler - Gil Pharmaceutical Corp (176826592)

Establishment
Name	Address	ID/FEI	Business Operations
Dextrum Laboratories Inc.		007392322	manufacture(58552-138)