GILTUSS CHILDRENS ALLERGY PLUS COUGH AND CONGESTION- chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride solution 
Gil Pharmaceutical Corp

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Giltuss Children's Allergy Plus Cough & Congestion

Drug Facts

Active ingredients (in each 5 mL)

Chlorpheniramine maleate USP, 2 mg

Dextromethorphan HBr USP, 10 mg

Phenylephrine HCl USP, 5 mg

Purposes

Antihistamine

Cough Suppressant

Nasal decongestant

Uses

Warnings

Do not use

  • to sedate a child or to 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 taking 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

Ask a doctor or pharmacist before use if the child is

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

When using this product

  • do not use more than directed
  • may cause marked drowsiness
  • excitability may occur, especially in children

Stop use and ask a doctor if

  • nervousness, dizzyness, or sleepless occurs
  • symptoms do not get better within 7 days or are accompanied by a fever
  • cough lasts more than 7 days, comes back, or is accompanied by fever, rash or persistent headache.

These could be signs of a serious condition.

If pregnant or breastfeeding,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 6 yearsConsult a Doctor
children 6 to under 12 years5 mL every 4 to 6 hours
adults and children 12 years and over10 mL every 4 to 6 hours

Other information

Inactive ingredients

citric acid, flavor, glycerin, methylparaben, propylparaben, purified water 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

giltuss.com

Children's

Giltuss® ALLERGY PLUS COUGH & CONGESTION

ANTIHISTAMINIC, ANTITUSSIVE, & NASAL DECONGESTANT

Alcohol Free. Sodium Free. Sugar Free. Dye Free.

TUTTI FRUTTI FLAVOR

4 FL OZ (118 mL)

58552-139 Child Allergy Cough Congestion

GILTUSS CHILDRENS ALLERGY PLUS  COUGH AND CONGESTION
chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58552-139
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE2 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
Coloryellow (Light yellow) Score    
ShapeSize
FlavorTUTTI FRUTTIImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58552-139-041 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(58552-139)

Revised: 10/2023
Document Id: 0874573f-0021-e21a-e063-6394a90affa9
Set id: 852c5a57-7ee4-3c5c-e053-2a91aa0a1433
Version: 4
Effective Time: 20231024
 
Gil Pharmaceutical Corp