GILTUSS CHILDRENS COUGH AND CHEST CONGESTION- dextromethorphan hydrobromide, guaifenesin solution 
Gil Pharmaceutical Corp

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Giltuss Children's Cough & Chest Congestion

Drug Facts

Active ingredients (in each 5 mL)

Dextromethorphan HBr, 10 mg

Guaifenesin, 100 mg

Purposes

Cough Suppressant

Expectorant

Uses

Warnings

Do not useif your child is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if the child has

  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or persistent or chronic cough that lasts such as occurs with asthma

Stop use and ask a doctor or pharmacist if the child has

  • symptoms do not get better within 7 days or are accompanied by fever
  • cough comes back, or is accompanied by fever, rash, or persistent headache.

These could be signs of a serious condition.

When using this product

  • do not use more than directed.

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 age2.5 mL every 4 hours
children 6 to under 12 years of age5 mL every 4 hours
children 12 years and over10 mL every 4 hours

Other information

Inactive ingredientsCitric acid, flavor, D&C red #33, flavor, methylparaben, propylene glycol, propylparaben, purified water, and sucrose

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 & CHEST CONGESTION

ANTITUSSIVE AND EXPECTORANT

Non-Drowsy. Alcohol Free

RASPBERRY FLAVOR

4FL OZ (118 mL)

58552-133 Child CoughChestCongestion

GILTUSS CHILDRENS COUGH AND CHEST CONGESTION 
dextromethorphan hydrobromide, guaifenesin solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58552-133
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
WATER (UNII: 059QF0KO0R)  
SUCROSE (UNII: C151H8M554)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
Product Characteristics
ColorpinkScore    
ShapeSize
FlavorRASPBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58552-133-041 in 1 CARTON10/02/2018
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 DrugM01210/02/2018
Labeler - Gil Pharmaceutical Corp (176826592)
Establishment
NameAddressID/FEIBusiness Operations
Dextrum Laboratories Inc.007392322manufacture(58552-133)

Revised: 10/2023
Document Id: 0874aef0-813f-3a20-e063-6294a90af74e
Set id: 852d5f01-9289-5515-e053-2a91aa0acf32
Version: 4
Effective Time: 20231024
 
Gil Pharmaceutical Corp