GILTUSS DIABETIC DM- dextromethorphan hbr solution

GILTUSS DIABETIC DM by

Drug Labeling and Warnings

GILTUSS DIABETIC DM by is a Otc medication manufactured, distributed, or labeled by Gil Pharmaceutical Corp, SEAWAY PHARMA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

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.

INDICATIONS & USAGE

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.

PURPOSE

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.

DOSAGE & ADMINISTRATION

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 SAFETY INFORMATION

Other information

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

INACTIVE INGREDIENT

Inactive ingredients

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

QUESTIONS

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.

KEEP OUT OF REACH OF CHILDREN

MANUFACTURED FOR

GIL PHARMACEUTICAL CORP.
PONCE, PUERTO RICO 00717-1565

PRINCIPAL DISPLAY PANEL

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

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

INGREDIENTS AND APPEARANCE

GILTUSS DIABETIC DM 
dextromethorphan hbr solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58552-149
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	30 mg  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
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
Shape		Size
Flavor	RASPBERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58552-149-04	1 in 1 CARTON	08/09/2023
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	08/09/2023

Labeler - Gil Pharmaceutical Corp (176826592)

Establishment
Name	Address	ID/FEI	Business Operations
SEAWAY PHARMA		117218785	analysis(58552-149) , manufacture(58552-149) , pack(58552-149)