GILTUSS COUGH AND COLD- dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride solution 
Dextrum Laboratories Inc.

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Giltuss Cough and Cold

Drug FactsActive Ingredients ( in each 5 mL)

Dextromethorphan HBr , 15 mg

Guaifenesin, 300 mg

Phenylephryne HCl, 10 mg

Purpouse Section & Uses

Cough supressant

Expectorant

Nasal Descongestant

Uses

temporary relieves cough due to minor throat and bronchial irritations as may occur with the common cold or inhaled irritants, helps loosen phlegm ( mucus) and thin bronchial secretions to make cough more productive, temporary relieves nasal congestion due to a cold. Purpose and uses

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 dont know if your prescription drug contains and MAOI , ask a doctor or pharmacist before taking this product, Warnings

Ask a Doctor

Ask a doctor before use if you have, heart disease, high blood pressure, thryroid disease, diabetes, or difficulty in urination due to enlargement of the prostate unless directed by a doctor, cough with too much phlegm ( mucus), a persistent or chronic cough as occurs with smoking, asthma,chronic bronchitis, or ephysema Ask a Doctor

Ask a doctor or pharmacist

Ask a doctor o pharmacist before use if you are taking any other oral nasal decongestant or stimulant, sedatives , tranquilizer, and drugs used for depression, especially monoamine oxidase inhibitors (MAOI's) Ask a doctor or pharmacist

Stop use

Stop useStop use and ask a doctor if, nervousness, dizziness, or sleeplessness occur, sympton do not get better within 7 days or are accompanied by fever, cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These can be signs of a serious condition.

Pregnancy or breast feeding

Pregnancy or breast feeding, ask a health professional before use. Keep out of reach of children. In case of accidental overdose, get medical or professional help or contact a Poison Control Center immediatly. If pregnant

Directions

Directions, do not exceed recommended dosage, do not take more than 6 doses in any 24 hours period, keep dosing cup for use with this product, ml=mililiters.

Adults and children 12 years & over 5 ml every 4 hours

children 6 to under 12 years age 2.5 ml every 4 hours

children 4 to 6 years of age 1.25 ml every 4 hours

children under 6 years of age Consult a doctor Directions

other information

Other information

Store at room temperature , between 15-30 oC

Keep thigtly closed

Save carton for complete drug facts other information

Inactive Ingredients

Inactive Ingredients

Questions

Questions

Call 1-787-848-9114, Monday-Friday 9 AM --5PM EST

Call your doctor for medical advice in the event of side effects. Questions

Keep out of reach of children

Keep out

Keep out of reach of children section

In case of accidental overdose, get medical or professional help or contact a Poison Control Center immediatly.

Indication and usage section

Indication and usage section

Do not exceed recommended dosage, do not take more than 6 doses in any 24 hours period, keep dosing cup for use with this product, ml=mililiters.

Adults and children 12 years & over 5 ml every 4 hours

children 6 to under 12 years age 2.5 ml every 4 hours

children 4 to 6 years of age 1.25 ml every 4 hours

children under 6 years of age Consult a doctor

indication an user

Principal panel

maximun strength

Giltuss Cold & cold

Alcohol free

Sugar free

Dye free

Cough, Phlem & Stuffy nose

Non-drowsy

Cherry flavor

4 flox 118 ml Principal panel

GILTUSS COUGH AND COLD 
dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65852-012
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN300 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
HYDROXYETHYLCELLULOSE (UNII: T4V6TWG28D)  
SORBITOL SOLUTION (UNII: 8KW3E207O2)  
CITRIC ACID (UNII: 2968PHW8QP)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65852-012-041 in 1 CARTON10/02/2018
1113 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01210/02/2018
Labeler - Dextrum Laboratories Inc. (007392322)

Revised: 9/2025
Document Id: 3f12ee8f-d1c7-d73a-e063-6394a90a9199
Set id: 3f12ee8f-d1c6-d73a-e063-6394a90a9199
Version: 1
Effective Time: 20250918
 
Dextrum Laboratories Inc.