Giltuss

Gil Pharmaceutical Corp
Hi-Tech Pharmacal Co., Inc.

Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredients
• Purposes
• Giltuss Uses
• Warnings
  • Do not use if
  • Ask a doctor before use if you have
  • Ask a doctor or pharmacist before use if you are
  • Stop use and ask a doctor if
  • If pregnant or breast-feeding,
  • Keep out of reach of children.
• Directions
• Giltuss Other information
• Inactive ingredients
• Questions or Comments?
• Package/Label Principal Display Panel

FULL PRESCRIBING INFORMATION

Active ingredients

(in each 5 mL teaspoonful) 

 Dextromethorphan HBr, 28 mg

Guaifenesin, 388 mg

Phenylephrine HCl, 10 mg

Purposes

Antitussive

Expectorant

Nasal Decongestant

Giltuss Uses

• temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
• helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive
• temporarily relieves nasal congestion due to a cold

Warnings

Do not use 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 do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

• heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate unless directed by a doctor
• a cough with too much phlegm (mucus)
• a persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema

Ask a doctor or pharmacist before use if you are

taking sedatives, tranquilizers and drugs used for depression, especially monoamine oxidase inhibitors (MAOIs).

Stop use and ask a doctor if

• nervousness, dizziness, or sleeplessness occur
• cough lasts for more than 7 days, comes back, or occurs with fever, rash or headache that lasts. These can be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

Directions

• do not exceed recommended dosage
• take every 6-8 hours

Giltuss Other information

• Tamper evident: Do not use if safety seal is broken or missing
• Store at controlled room temperature, between 15°-30°C (59°-86°F)

Inactive ingredients

Artificial grape and vanilla flavor, bitter mask, citric acid, grapeskin extract, menthol, monoammonium glycyrrhizinate, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose. Sodium citrate may be used to adjust pH.

Questions or Comments?

Call 1-877-746-9114, Mon.-Fri. 8:00 am thru 5:00 pm EST. Call your doctor for medical advice in the event of side effects.

Rev. 324:01 6/10

Package/Label Principal Display Panel

NDC 58552-122-08

GILTUSS^®

NEW IMPROVED FORMULA

ANTITUSSIVE

EXPECTORANT AND

NASAL DECONGESTANT

SUGAR FREE

ALCOHOL FREE

Each 5 mL (one teaspoonful) contains:

Dextromethorphan HBr............................28 mg

Guaifenesin.............................................388 mg

Phenylephrine HCl..................................10 mg