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4060-Gil


Drug Facts

Active Ingredients (in each tablet)

Guaifenesin 388 mg

Dextromethorphan HBr 28 mg

Phenylephrine HCl 10 mg


OTC - PURPOSE SECTION

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

OTC - DO NOT USE SECTION

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.


OTC - ASK DOCTOR SECTION

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

OTC - STOP USE SECTION

Stop use and ask a doctor if

These could be signs of a serious condition.

  • 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

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding,ask a health professional before use.


OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children.


OVERDOSAGE SECTION

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.

INACTIVE INGREDIENT SECTION

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


SPL UNCLASSIFIED SECTION

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


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