GILTUSS TOTAL RELEASE - guaifenesin, dextromethorphan hydrobromide and phenylephrine hydrochloride tablet
Gil Pharmaceutical Corp

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active Ingredients (in each tablet)

Guaifenesin 388 mg

Dextromethorphan HBr 28 mg

Phenylephrine HCl 10 mg

Purposes

Expectorant

Antitussive

Nasal Decongestant

Uses

temporarily relieves these symptoms associated with a cough, the common cold, hay fever, or other upper respiratory allergies
helps loosen phlegm (mucus)
loosens nasal congestion
thin bronchial secretions
drain bronchial tubes
make coughs more productive
clears stuffy nose
clear nasal passageways
shrinks swollen membranes

Warnings

Do not use

more than the recommended dosage
this product 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 are uncertain whether your prescription drug contains an MAOI, ask a health professional.

Ask a doctor before use if you have

heart disease
excessive phlegm (mucus)
high blood pressure
diabetes
thyroid disease
difficulty in urination due to enlargement of the prostate gland
persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Stop use and ask a doctor if

nervousness, dizziness, or sleeplessness occurs
symptoms are accompanied by fever, rash, persistent headache, or excessive phlegm (mucus)
cough and congestion do not improve within 7 days or tend to recur . These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of the reach of children.

In case of accidental overdose, get medical help or contact a Poison Control Center immediately.

Directions

Adults and Children over 12 years of age: take 1 tablet every 4 hours as needed. Do not exceed 6 tablets in 24 hours
Children 6 to under 12 years of age: take 1/2 tablet every 4 hours as needed. Do not exceed 3 tablets in 24 hours
Children under 6 years of age: ask a doctor

Other Information

store at room temperature, USP
do not use if imprinted safety seal under cap is broken or missing.

Inactive Ingredients

Croscarmellose Sodium, Dicalcium Phosphate, Hypromellose, Magnesium Silicate, Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, Mineral Oil, Polyvinylpyrrolidone, Silica, Sodium Lauryl Sulfate, Stearic Acid, Titanium Dioxide and Triacetin.

Questions?

Call 787-848-9114

Manufactured for:

GIL PHARMACEUTICAL CORP.

Ponce, Puerto Rico 00717-1565

LBL 4060 Label revised: 04/11

Package/Label Principal Display Panel

GILTUSS®

TOTAL RELEASE
EXPECTORANT, ANTITUSSIVE, AND NASAL DECONGESTANT

SUGAR FREE AND PRESERVATIVE FREE

Each scored tablet contains:

Guaifenesin................................388 mg.

Dextromethorphan HBr................28 mg.

Phenylephrine HCl........................10 mg.

100 Tablets

MANUFACTURED FOR:

GIL PHARMACEUTICAL CORP.

PONCE, PUERTO RICO 00717-1565

GILTUSS TOTAL RELEASE
guaifenesin, dextromethorphan hbr, and phenylephrine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58552-317
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (GUAIFENESIN)	GUAIFENESIN	388 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN)	DEXTROMETHORPHAN HYDROBROMIDE	28 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE)	PHENYLEPHRINE HYDROCHLORIDE	10 mg

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
HYPROMELLOSE 2910 (6 MPA.S)
MAGNESIUM SILICATE
MAGNESIUM STEARATE
MALTODEXTRIN
CELLULOSE, MICROCRYSTALLINE
MINERAL OIL
POVIDONE K30
SILICON DIOXIDE
SODIUM LAURYL SULFATE
STEARIC ACID
TITANIUM DIOXIDE
TRIACETIN

Product Characteristics
Color	WHITE	Score	2 pieces
Shape	OVAL	Size	15mm
Flavor		Imprint Code	GIL;317
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:58552-317-02	12 BLISTER PACK in 1 CARTON	contains a BLISTER PACK
1		2 TABLET in 1 BLISTER PACK	This package is contained within the CARTON (58552-317-02)
2	NDC:58552-317-01	100 TABLET in 1 BOTTLE	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	10/19/2009

Labeler - Gil Pharmaceutical Corp (176826592)

Registrant - Hi-Tech PHarmacal Co., Inc. (101196749)

Establishment
Name	Address	ID/FEI	Operations
Contract Pharmacal Corporation		968334974	MANUFACTURE

Revised: 09/2011 Gil Pharmaceutical Corp