GILTUSS DM- dextromethorphan hbr syrup

Giltuss DM by

Drug Labeling and Warnings

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

Drug Details [pdf]

Drug Facts

Active ingredient (in each 10 mL) Purpose

Dextromethorphan HBr. 30 mg .... Cough Suppresant

PURPOSE

INDICATIONS & USAGE

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.

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.

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

• 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

STORAGE AND HANDLING

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.

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

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

INGREDIENTS AND APPEARANCE

GILTUSS DM 
dextromethorphan hbr syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58552-150
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
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
Color	white (clear color)	Score
Shape		Size
Flavor	RASPBERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58552-150-04	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	06/27/2023

Labeler - Gil Pharmaceutical Corp (176826592)