GILTUSS CHILDRENS COUGH AND COLD- dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride solution 
Gil Pharmaceutical Corp

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Giltuss Children's Cough & Cold

Drug Facts

Active ingredients (in each 2.5 mL)

Dextromethorphan HBr 7.5 mg

Guaifenesin 150 mg

Phenylephrine HCI 5 mg

Purposes

Cough Suppressant

Expectorant

Nasal decongestant

Uses

Warnings

Do not use

  • to sedate a child or make a child sleepy
  • in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

Ask a doctor before use if the child has

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • glaucoma
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or persistent or chronic cough that lasts such as occurs with asthma or chronic bronchitis

Ask a doctor or pharmacist before use if the child is

  • taking any other oral nasal decongestant or stimulant
  • taking sedatives, tranquilizers

  • Stop use and ask a doctor if
  • nervousness, dizziness, or sleepless occurs
  • symptoms do not get better within 7 days or are accompanied by fever
  • cough lasts more than 7 days, comes back, or occurs with fever, rash or persistant headache

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 overdose, get medical help or contact a Poison Control Center right away.

Directions

children under 2 yearsConsult a doctor
children 2 to under 6 years of age1.25 mL every 4 hours
children 6 to 12 years of age2.5 mL every 4 hours
children 12 years and over5 mL every 4 hours

Other information

Inactive ingredients

citric acid, flavor, glycerin, hydroxyethylcellulose, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sorbitol solution, and sucralose.

Questions or comments?

Call 1-787-848-9114, Monday - Friday 9AM - 5PM EST. Call your doctor for medical advice in the event of side effects.

Tamper evident: do not use if safety seal is broken or missing

MANUFACTURED FOR

GIL PHARMACEUTICAL CORP.

PONCE, PUERTO RICO 00717-1565

Children's

GILTUSS®

COUGH & COLD

ANTITUSSIVE, EXPECTORANT, NASAL DECONGESTANT

Alcohol Free. Sugar Free. Dye Free.

CHERRY FLAVOR

4 FL OZ (118 mL)

58552-131 Child Cough Cold Liq

GILTUSS CHILDRENS COUGH AND COLD 
dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58552-131
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE7.5 mg  in 2.5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN150 mg  in 2.5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 2.5 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) (UNII: S38J6RZN16)  
GLYCERIN (UNII: PDC6A3C0OX)  
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58552-131-041 in 1 CARTON11/07/2018
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01211/07/2018
Labeler - Gil Pharmaceutical Corp (176826592)
Establishment
NameAddressID/FEIBusiness Operations
Dextrum Laboratories Inc.007392322manufacture(58552-131)

Revised: 10/2023
Document Id: 0874f27e-12f4-aacf-e063-6294a90acccd
Set id: 852b77ae-a5ac-3ead-e053-2a91aa0a54bd
Version: 4
Effective Time: 20231024
 
Gil Pharmaceutical Corp