Giltuss D by Dextrum Laboratories Inc. GILTUSS D syrup

Giltuss D by

Drug Labeling and Warnings

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

Drug Details [pdf]

Purposes

Purposes

Antihistamine

Nasal decongestant

Uses

Temporary relieves these symptons due to hay fever ( allergy rhinitis) or other respiratory allergies:

runny nose, sneezing, itchy, watery eyes, nasal congestion, itching of nose or throat, sinus congestion and pressure

Warnings

Warnings:

Do not use to sedate a child or to make a child sleepy, if you ar etaking a prescription monoamine oxidase inhibitor ( MAOI) ( certains 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

Ask a doctor before use if you have:

Heart desease, high blood pressure, thyroid desease, diabetes, trouble urinating due to enlarged prostate gland, glaucoma, a breathing problem or persistent or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis, or ephysema

Ask a doctor or pharmacist

Ask a doctor or pharmacist before use if you are, taking sedatives or tranquilizers

When using

When using this product, do not use more than directed, may cause drowsiness, avoid alcoholic beverages, alcohol, sedatives, and tranquilizers may increase drowsiness, avoid alcoholic drinks, be careful when driving a motor vehicle or operating machinery, exitability may occur, especially in children.

Pregnancy or breast-feeding

If Pregnancy or breast-feeding, ask a health professional before use. Keep out of reach of children. In case or overdose, get medical help or contact a Poisson Control Center right away ( 1-800-222-1222)

Stop use section

Stop use and ask a doctor if, if you get nervous, dizzy or sleepless, symptons do not get better witi

hin 7 days or are accompanied by fever

ACTIVE INGREDIENT

Chlorpheniramine maleate 3.5 mg

Phenilephryne HCl, 10 mg

Directions

Directions, not take more than 6 doses in any 24 hours period, use enclosed dosing cup, keep dosage cup for use with this product, ml= mililiter

Adults and children 12 years and over 10 ml every 4 hours

Children 6 to under 12 years 5 ml every 4 hours

Children under 6 years Consult a doctor

Other information

Other information store at room temperature 15 - 30 oC (59-86 o F), close cap tightly, save carton for complete drug facts

Inactive ingredients

Inactive Ingredients

Citric Acid, Flavor, Glycerin, Methylparaben, Propylene Glycol, Propylparaben, Purified water, Sodium Carboxymethylcellulose, Sucralose.

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

Indication and usage section

Indication and usage section

Do not take more than 6 doses in any 24 hours period, use enclosed dosing cup, keep dosage cup for use with this product,

ml= mililiter

Adults and children 12 years and over 10 ml every 4 hours

Children 6 to under 12 years 5 ml every 4 hours

Children under 6 years Consult a doctor

Keep out of reach of children.

Keep out of reach of children.

In case or overdose, get medical help or contact a Poison Control Center right away ( 1-800-222-1222)

PRINCIPAL DISPLAY PANEL

Giltuss D

Allergy & Congestion

Dye Free, preservative free, sodium free, sugar free

Sneezing, Runny Nose, Itchy & Water eyes, Itchy Throat or Nose, Sinus pressure, stuffy nose

Tutti Frutti Flavor

$ floz 118 ml

INGREDIENTS AND APPEARANCE

GILTUSS D 
giltuss d syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65852-010
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg  in 10 mL
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	3.5 mg  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID (UNII: 2968PHW8QP)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SUCRALOSE (UNII: 96K6UQ3ZD4)
WATER (UNII: 059QF0KO0R)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Product Characteristics
Color		Score
Shape		Size
Flavor	TUTTI FRUTTI	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65852-010-04	1 in 1 CARTON	04/11/2024
1		118 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	04/11/2024

Labeler - Dextrum Laboratories Inc. (007392322)