GILTUSS DIABETIC DM- dextromethorphan hbr solution 
Gil Pharmaceutical Corp

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Giltuss Diabetic DM
Dextromethorphan HBr, 30 mg
Maximum Strength

Drug Facts

Active Ingredient (In each 10 mL)                                       Purpose

Dextromethorphan HBr. 30 mg ......................... Cough Suppresant

Uses

  • temporarily relieves:
    • cough due to minor throat and bronchial irritation associated with a common cold or inhaled irritants
    • the intensity of coughing
    • the impulse to cough to help you get to sleep

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

  • do not exceed recommended dosage
  • do not take more than 4 doses in any 24-hour period
  • use enclosed dosing cup
  • mL= milliliter
*
use appropriate measuring syringe or measuring cup

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

Other information

  • store at room temperature 15°-30°C (59°-86°F)
  • close cap tightly
  • SAVE CARTON FOR COMPLETE DRUG FACTS

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.

MANUFACTURED FOR

GIL PHARMACEUTICAL CORP.
PONCE, PUERTO RICO 00717-1565

PRINCIPAL DISPLAY PANEL

Giltuss Diabetic DM - NDC 58552-149-04 - Bottle Label

image description

Giltuss Diabetic DM - NDC 58552-149-04 - Carton Label

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GILTUSS DIABETIC DM 
dextromethorphan hbr solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58552-149
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
POVIDONE (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
GLYCERIN (UNII: PDC6A3C0OX)  
MENTHOL (UNII: L7T10EIP3A)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
Product Characteristics
Color    Score    
ShapeSize
FlavorRASPBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58552-149-041 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 finalpart34108/09/2023
Labeler - Gil Pharmaceutical Corp (176826592)
Establishment
NameAddressID/FEIBusiness Operations
SEAWAY PHARMA117218785analysis(58552-149) , manufacture(58552-149) , pack(58552-149)

Revised: 9/2023
 
Gil Pharmaceutical Corp