GILTUSS DM- dextromethorphan hbr syrup 
Gil Pharmaceutical Corp

----------

Giltuss ®DM High Blood Pressure
Dextromethorphan HBr, 30 mg
Maximum Strength

Drug Facts

Active ingredient (in each 10 mL) Purpose

Dextromethorphan HBr. 30 mg .... Cough Suppresant

Uses

■ temporarily relieves:

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.
  • When using this product do not use more than directed.

Ask a doctor before use if you have

  • a cough with too much phlegm (mucus)
  • a persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis or emphysema

Stop use and ask a doctor if

cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache as these could 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

Adults and children over 12 years

10 mL every 8 hours

Children under 6 years to under 12 years

5 mL every 8 hours

Children 4 years to under 6 years

2.5 mL* every 8 hours

Children under 4 years

Do not use

*use appropriate measuring syringe or measuring cup

Other information

Inactive ingredients

Acesulfame potassium, citric acid, flavor, glycerin, menthol, polyethylene glycol, povidone, propylene glycol, purified water, sodium benzoate, sodium saccharin.

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.

Label revised: 02/23

MANUFACTURED FOR
GIL PHARMACEUTICAL CORP.
PONCE, PUERTO RICO 00717-1565

PRINCIPAL DISPLAY PANEL

Giltuss DM High Blood Pressure - NDC 58552-150-04 - Bottle Label

image description

Giltuss DM High Blood Pressure - NDC 58552-150-04 - Carton Label

image description

GILTUSS DM 
dextromethorphan hbr syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58552-150
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE30 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
RASPBERRY (UNII: 4N14V5R27W)  
GLYCERIN (UNII: PDC6A3C0OX)  
MENTHOL (UNII: L7T10EIP3A)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
Product Characteristics
Colorwhite (clear color) Score    
ShapeSize
FlavorRASPBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58552-150-041 in 1 CARTON08/09/2023
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 DrugM01206/27/2023
Labeler - Gil Pharmaceutical Corp (176826592)

Revised: 12/2023
Document Id: 0bbd8b25-8a8e-00dd-e063-6294a90ac1e0
Set id: 1a4fe686-3085-4543-bd6c-f20580b1df50
Version: 3
Effective Time: 20231205
 
Gil Pharmaceutical Corp