GILTUSS COUGH AND COLD- dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride solution

Giltuss Cough and Cold by

Drug Labeling and Warnings

Giltuss Cough and Cold by is a Otc medication manufactured, distributed, or labeled by Dextrum Laboratories Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active 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.

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,

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 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)

Stop use

Stop 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.

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

other information

Other information

Store at room temperature , between 15-30 oC

Keep thigtly closed

Save carton for complete drug facts

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.

Keep out of reach of children

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

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

INGREDIENTS AND APPEARANCE

GILTUSS COUGH AND COLD 
dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65852-012
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	15 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	300 mg  in 5 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65852-012-04	1 in 1 CARTON	10/02/2018
1		113 mL in 1 BOTTLE, PLASTIC; 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	10/02/2018

Labeler - Dextrum Laboratories Inc. (007392322)