GILTUSS ALLERGY PLUS- chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride solution

Giltuss Allergy Plus by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active ingredients

Active ingredients (in each 10 m) Purposes

Chlorpheniramine maleate, USP 4 mg -------------------------------Antihistamine

Dextromethorphan HBr, USP 20 mg -----------------------------------Cough supressant

Phenylephrine HCl, USP 10 mg -----------------------------------------Nasal descongestant

Uses

Uses

Temporary relieves:

Cough due to minor throat and bronchial irritation associated 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 your child is 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 don’t know is 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, thyroid disease, diabetes, or difficulty in urination due to an enlarged prostate unless directed by a doctor, a cough with too much phlegm (mucus), a persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema

Ak a doctor or pharmacist before use it

As a doctor or pharmacist before use if you ar etaking any other oral nasal descongestant or stimulant, sedatives, tranquilizer, and drugs used for depression, especially momoamine oxidase inhibitors ( MAOI)

Stop use and ask a doctor if

Stop use and ask a doctor if

if you get nervous, dizzy, or sleepless, symptoms do not get better within 7 days or are accompanied by fever, cough lasts more than 7 days, comeback, or is accompanied by fever,rash, or persistent headache

These could be signs of a serious condition.

If pregnant or breast-feeding

If pregnant 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 Poisson Control center immediately

Directions

Directions

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= milliliters

Adults and children 12 years & over 10 ml every 4 to 6 hours

Children 6 to under 12 years of age 5 ml every 4 to 6 hours

Children under 6 years of age Consult a doctor

hildren under 6 years of age Consult a doctor

Other information

Other information

Store at room temperature 15-30 °C (59° -86 ° F)
Close cap tightly
SAVE CARTON FOR COMPLETE DRUG FACTS

Inactive Ingredients

Inactive Ingredients

Citric Acid, flavor, glycerin, methylparaben, propylparaben, purified water and sucralose

Questions or comments?

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

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= milliliters

Adults and children 12 years & over 10 ml every 4 to 6 hours

Children 6 to under 12 years of age 5 ml every 4 to 6 hours

Children under 6 years of age Consult a doctor

keep out of reach of children section

keep out of reach of children section

. In case of accidental overdose, get medical or professional help or contact a Poisson Control center immediately

PRINCIPAL DISPLAY PANEL

Maximum strength

Giltuss Allergy Plus

Cough & Congestion

Alcohol free, Sodium free, sugar free, dye free

Sneezing, runny nose, itchy and watery eyes, cough, stuffy nose, sinus pressure

Tutti Frutti flavor

4 floz 118 ml

INGREDIENTS AND APPEARANCE

GILTUSS ALLERGY PLUS 
chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65852-017
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg  in 10 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg  in 10 mL
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	4 mg  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
CITRIC ACID (UNII: 2968PHW8QP)
METHYLPARABEN (UNII: A2I8C7HI9T)
GLYCERIN (UNII: PDC6A3C0OX)

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: 65852-017-04	1 in 1 CARTON	10/02/2018
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	10/02/2018

Labeler - Dextrum Laboratories Inc. (007392322)