GILTUSS HONEY DM COUGH- dextromethorphan hbr solution

Giltuss Honey DM Cough by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient (in each 10 mL)

Dextromethorphan HBr, 30 mg

PURPOSE

Purposes

Cough Suppresant

INDICATIONS & USAGE

Uses

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

WARNINGS

Warnings

Do not useif 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.

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 ifcough 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.

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 take more than 4 doses in any 24-hour period
• use enclosed dosing cup
• keep dosage cup for use with this product
• ml = milliliters
  • adults and children 12 years and over: 10 mL every 6-8 hours
  • children 6 to under 12 years of age: 5 mL every 6-8 hours
  • children 4 to under 6 years of age: 2.5 mL every 6-8 hours
  • children under 4 years of age: Consult a doctor

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 ingredientsnatural and artificial flavor, natural grade A honey, methylparaben, potassium sorbate, propylene glycol, propylparaben, purified water, sucralose.

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.

SPL UNCLASSIFIED SECTION

Tamper Evident: do not use if safety seal is broken or missing.

MANUFACTURED FOR

GIL PHARMACEUTICAL CORP.

PONCE, PUERTO RICO 00717-1565

giltuss.com

PRINCIPAL DISPLAY PANEL

MAXIMUM STRENGTH

Giltuss®

Honey DM Cough

Made with real honey

ALCOHOL FREE. DYE FREE. NON-DROWSY

RELIEVES

PERSISTENT COUGH UP TO 8 HOURS

HONEY LEMON FLAVOR.

4FL OZ (118 mL)

INGREDIENTS AND APPEARANCE

GILTUSS HONEY DM COUGH 
dextromethorphan hbr solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58552-143
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
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
Color	yellow (Light yellow)	Score
Shape		Size
Flavor	HONEY, LEMON	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58552-143-04	1 in 1 CARTON	06/22/2020
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	06/22/2020

Labeler - Gil Pharmaceutical Corp (176826592)

Establishment
Name	Address	ID/FEI	Business Operations
Dextrum Laboratories Inc		007392322	manufacture(58552-143)