GILTUSS TOTAL RELEASE

Dosage form: tablet
Ingredients: GUAIFENESIN 388mg, DEXTROMETHORPHAN HYDROBROMIDE 28mg, PHENYLEPHRINE HYDROCHLORIDE 10mg
Labeler: Gil Pharmaceutical Corp
NDC Code: 58552-317

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.

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

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:58552-317
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN388 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE28 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
CALCIUM PHOSPHATE, DIBASIC, 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
ColorWHITEScore2 pieces
ShapeOVALSize15mm
FlavorImprint CodeGIL;317
Contains    
Packaging
#Item CodePackage Description
1NDC:58552-317-0212 BLISTER PACK in 1 CARTON
12 TABLET in 1 BLISTER PACK
2NDC:58552-317-01100 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/19/2009
Labeler - Gil Pharmaceutical Corp (176826592)
Establishment
NameAddressID/FEIOperations
Contract Pharmacal Corporation968334974MANUFACTURE(58552-317)

Revised: 03/2012
 
Gil Pharmaceutical Corp

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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