Your browser does not support JavaScript! GILTUSS (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [GIL PHARMACEUTICAL CORP]
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RxNorm Names

GILTUSS (dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride) syrup
[Gil Pharmaceutical Corp]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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 Label Sections

Active ingredients

(in each 5 mL teaspoonful) 

 Dextromethorphan HBr, 28 mg

Guaifenesin, 388 mg

Phenylephrine HCl, 10 mg

Purposes

Antitussive

Expectorant

Nasal Decongestant

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
adults and children 12 years & over5 mL (1 teaspoonful)
children 6 to under 12 years of age2.5 mL (1/2 teaspoon)
children 2 to 6 years of age1.25 mL (1/4 teaspoon)
children under 2 years of ageConsult a doctor

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

Image of Container Label

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

GILTUSS 
dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride syrup
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:58552-122
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE28 mg  in 5 mL
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN388 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
POLYETHYLENE GLYCOL 1450 
PROPYLENE GLYCOL 
MENTHOL 
SORBITOL 
SUCRALOSE 
ANHYDROUS CITRIC ACID 
SODIUM BENZOATE 
GLYCYRRHIZIN, AMMONIATED 
ANHYDROUS TRISODIUM CITRATE 
Product Characteristics
ColorPURPLE (clear, purple) Score    
ShapeSize
FlavorGRAPE (artificial grape flavor and grapeskin extract powder) , VANILLA (artificial vanilla flavor) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58552-122-08237 mL in 1 BOTTLE
2NDC:58552-122-0130 mL 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)
Registrant - Hi-Tech Pharmacal Co., Inc. (101196749)
Establishment
NameAddressID/FEIBusiness Operations
Hi-Tech Pharmacal Co., Inc.101196749MANUFACTURE

Revised: 5/2011
 
Gil Pharmaceutical Corp

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