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Giltuss TR

Dosage form
TABLET
Labeler
Syntho Pharmaceuticals, Inc.
Label updated
2022-06-13
Retrieved
2026-09-07
Active ingredients
DEXTROMETHORPHAN HYDROBROMIDE · GUAIFENESIN
View original label and images on DailyMed ↗
Drug Facts

Active Ingredients (in each tablet)

Guaifenesin 390 mg.

Dextromethorphan HBr 29 mg.

Phenylephrine HCl 10 mg.

Purposes

Expectorant

Antitussive

Nasal Decongestant

Uses

Temporarily relieves the 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, clear stuffy nose, clear nasal passageways, and shrinks swollen membranes.

Warnings

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.

Label information

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.

Label information

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.

Inactive Ingredients

Hydroxypropyl Methylcellulose, Magnesium Stearate, Maltodextrin, Microcrystalline  Cellulose, Polyethylene Glycol, Povidone, Silicone Dioxide and Stearic Acid.

Questions? Call 787-848-9114

Manufactured for:
GIL PHARMACEUTICAL CORP.,
Ponce, Puerto Rico 00716

Manufactured by:
Syntho Pharmaceuticals, Inc.
Farmingdale, New York (NY) 11735
Label revised: 04/22

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Giltuss ® Total Release - NDC-66576-335-01 - 100's Bottle Label.

[Image in the official label — see DailyMed source]

DailyMed Set ID: bb7098fc-458f-47ed-8d09-7581d8eb17ec · Version 1
NDC: 66576-335