Drug Facts

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

Do not use this product more than the recommended dosage, or 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

Do not exceed recommended doses in a 24 hour period

• Adults and Children 12 years and over: 1 tablet every 6 to 8 hours. Do not exceed 4 tablets in 24 hours.

• Children 6 to 12 years: 1/2 tablet every 6 to 8 hours. Do not exceed 2 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.

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

Giltuss TR

NDC 58552-317-02

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 00716

4060-24BB-1

4060-24BB-2

Exactuss TR

NDC: 58552-327-01

Exactuss

Total Release

Expectorant, Antitissive, and Nasal Decongestant

Sugar Free and Preservative free

Exactuss TR is the bioequivalent and contains the exact ingredients of Giltuss TR

100 Tablets

Manufactured For

Gil Pharmaceutical Corp.

Ponce, Puerto Rico 00716

4060-100G Label

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

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	388 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	28 mg

Ingredient Name	Strength
Inactive Ingredients
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)
HYPROMELLOSES (UNII: 3NXW29V3WO)
TALC (UNII: 7SEV7J4R1U)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
POVIDONE K30 (UNII: U725QWY32X)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)

Product Characteristics
Color	white	Score	2 pieces
Shape	OVAL	Size	15mm
Flavor		Imprint Code	GIL;GIL;303;303
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:58552-317-02	12 in 1 CARTON	07/15/2011
1		2 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:58552-317-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	05/27/2011	11/30/2020

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

EXACTUSS TOTAL RELEASE
guaifenesin, dextromethorphan hbr, and phenylephrine hcl tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58552-327
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	388 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	28 mg

Ingredient Name	Strength
Inactive Ingredients
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)
HYPROMELLOSES (UNII: 3NXW29V3WO)
TALC (UNII: 7SEV7J4R1U)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
POVIDONE K30 (UNII: U725QWY32X)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)

Product Characteristics
Color	white	Score	2 pieces
Shape	OVAL	Size	15mm
Flavor		Imprint Code	GIL;GIL;303;303
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:58552-327-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	05/27/2011

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

Labeler - Gil Pharmaceutical Corp (176826592)