GILTUSS SINUS AND CHEST CONGESTION- guaifenesin, phenylephrine hcl tablet 
Gil Pharmaceutical Corp

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4062- Giltuss Sinus & Chest Congestion Tablets

Drug Facts

Active Ingredient (in each tablet)

Guaifenesin 388 mg

Phenylephrine HCl 10 mg

Purpose

Expectorant

Nasal Decongestant

Uses

temporarily relieves the symptoms associated with a cough, the common cold, hay fever, or other upper respiratory allergies

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

Do not exceed recommended doses in a 24 hour period

Other information

Other information

Inactive ingredients Croscarmellose Sodium, Hypromellose, Lactose, Magnesium Silicate, Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, Mineral Oil, Polyethylene Glycol, 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.com

MAXIMUM STRENGTH

GILTUSS®

SINUS & CHEST CONGESTION

20 TABLETS

NON-DROWSY. DYE FREE. PRESERVATIVE . SODIUM FREE

RELIEVES

58552-332 Sinus Chest Congestion 11-2-2018

GILTUSS SINUS AND CHEST CONGESTION 
guaifenesin, phenylephrine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58552-332
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN388 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
LACTOSE (UNII: J2B2A4N98G)  
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)  
TALC (UNII: 7SEV7J4R1U)  
Product Characteristics
ColorwhiteScore2 pieces
ShapeOVALSize19mm
FlavorImprint Code GILGIL;304304
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58552-332-202 in 1 CARTON04/01/2021
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01204/01/2021
Labeler - Gil Pharmaceutical Corp (176826592)

Revised: 10/2023
Document Id: 0877054f-1f52-e585-e063-6294a90a16b3
Set id: 8591003c-c2f2-df65-e053-2a91aa0a42fb
Version: 4
Effective Time: 20231024
 
Gil Pharmaceutical Corp