CHILDRENS GILTUSS HONEY DM COUGH- dextromethorphan hbr solution 
Gil Pharmaceutical Corp

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Giltuss Honey DM, Childrens

Drug Facts

Active ingredient (in each 5 mL)

Dextromethorphan HBr, 15 mg

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 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 persistent or chronic cough such as occurs with asthma

Stop use and ask a doctor if the child hasa cough that lasts for more than 7 days, comes back, or is accompanied by fever, rash or persistent headache. These could be signs of a serious condition.

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

children under 4 yearsConsult a doctor
children 4 to under 6 years2.5 mL every 6-8 hours
children 6 to under 12 years5 mL every 6-8 hours
children 12 years and over10 mL every 6-8 hours

Other information

Inactive ingredientsnatural and artificial flavor, natural grade A honey, methylparaben, potassium sorbate, propylene glycol, propylparaben, purified water, 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 4-12

Children's Giltuss®

Honey DM Cough

Alcohol Free. Dye Free. Non Drowsy.

PERSISTENT COUGH UP TO 8 HOURS

Made with real honey

HONEY LEMON FLAVOR.

4FL OZ (118 mL)

58552-144 Honey DM Child

CHILDRENS GILTUSS HONEY DM COUGH 
dextromethorphan hbr solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58552-144
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
HONEY (UNII: Y9H1V576FH)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Product Characteristics
Coloryellow (Light yellow) Score    
ShapeSize
FlavorHONEY, LEMONImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58552-144-041 in 1 CARTON06/22/2020
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 DrugM01206/22/2020
Labeler - Gil Pharmaceutical Corp (176826592)
Establishment
NameAddressID/FEIBusiness Operations
Dextrum Laboratories Inc007392322manufacture(58552-144)

Revised: 10/2023
Document Id: 0873b36b-c381-9a53-e063-6294a90aee0e
Set id: a8c5027f-9701-fb07-e053-2a95a90a6029
Version: 4
Effective Time: 20231024
 
Gil Pharmaceutical Corp