GILTUSS ALLERGY PLUS COUGH AND CONGESTION- chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride

United States - English - NLM (National Library of Medicine)

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Active ingredient:
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U), DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS), PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)
Available from:
Gil Pharmaceutical Corp
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Purposes Antihistamine Cough suppressant Nasal decongestant Uses - temporarily relieves - cough due to minor throat and bronchial irritation associated with a cold or inhaled irritants - nasal congestion due to the common cold, hay fever or other upper respiratory allergies - temporarily relieves these symptoms due to hay fever (allergic rhinitis): - runny nose - sneezing - itchy, watery eyes - itching of the nose or throat - temporarily restores freer breathing through the nose
Authorization status:
OTC monograph final
Authorization number:
58552-138-04

GILTUSS ALLERGY PLUS COUGH AND CONGESTION- chlorpheniramine maleate,

dextromethorphan hydrobromide, phenylephrine hydrochloride solution

Gil Pharmaceutical Corp

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Giltuss Allergy Plus Cough & Congestion

Drug Facts

Active ingredients (in each 10 mL)

Chlorpheniramine maleate, USP 4 mg

Dextromethorphan HBr, USP 20 mg

Phenylephrine HCl, USP 10 mg

Purpos es

Antihistamine

Cough suppressant

Nasal decongestant

Uses

temporarily relieves

cough due to minor throat and bronchial irritation associated with a cold or inhaled irritants

nasal congestion due to the common cold, hay fever or other upper respiratory allergies

temporarily relieves these symptoms due to hay fever (allergic rhinitis):

runny nose

sneezing

itchy, watery eyes

itching of the nose or throat

temporarily restores freer breathing through the nose

Warnings

Do not use

to sedate a child or to make a child sleepy

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 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

heart disease

high blood pressure

thyroid disease

diabetes

trouble urinating due to enlargement of the prostate gland

glaucoma

cough that occurs with too much phlegm (mucus)

a breathing problem or persistent or chronic cough that lasts such as occurs with smoking, asthma,

chronic bronchitis or emphysema

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers

taking any other oral nasal decongestant or stimulant

When using this product

do not use more than directed

may cause marked drowsiness

avoid alcoholic beverages

alcohol, sedatives and tranquilizers may increase drowsiness effect

be careful when driving a motor vehicle or operating machinery

excitability may occur, especially in children

Stop use and ask a doctor if

you get nervous, dizzy, or sleepless

symptoms do not get better within 7 days or are accompanied by a fever

cough lasts 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 breastfeeding,ask a health professional before use.

Keep out of reach of children. In case of overdose, seek professional help or contact a Poison Control

Center right away.

Directions

Do not take more than 6 doses in any 24-hour period

use enclosed dosing cup

keep dosage cup for use with this product

mL=milliter

adults and children 12

years and over

10 mL every 4 to 6 hours

children 6 to under 12

years

5 mL every 4 to 6 hours

children under 6 years Consult a Doctor

Other information

store at room temperature 15° - 30°C (59° - 86°F)

close cap tightly

SAVE CARTON FOR COMPLETE DRUG FACTS

Inactive ingredients

citric acid, flavor, glycerin, methylparaben, propylparaben, purified water and 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.

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

MANUFACTURED FOR

GIL PHARMACEUTICAL CORP.

PONCE, PUERTO RICO 00717-1565

giltus s .com

MAXIMUM STRENGTH

Giltuss® ALLERGY PLUS COUGH & CONGESTION

ANTIHISTAMINIC, ANTITUSSIVE, & NASAL DECONGESTANT

ALCOHOL FREE. SODIUM FREE. SUGAR FREE. DYE FREE.

RELIEVES

SNEEZING

RUNNY NOSE

ITCHY AND WATERY EYES

COUGH

STUFFY NOSE

SINUS PRESSURE

TUTTI FRUTTI FLAVOR

4FL OZ (118 mL)

GILTUSS ALLERGY PLUS COUGH AND CONGESTION

chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride solution

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:58 552-138

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

CHLO RPHENIRAMINE MALEATE (UNII: V1Q0 O9 OJ9 Z) (CHLORPHENIRAMINE -

UNII:3U6 IO 19 6 5U)

CHLORPHENIRAMINE

MALEATE

4 mg

in 10 mL

DEXTRO METHO RPHAN HYDRO BRO MIDE (UNII: 9 D2RTI9 KYH)

(DEXTROMETHORPHAN - UNII:7355X3ROTS)

DEXTROMETHORPHAN

HYDROBROMIDE

20 mg

in 10 mL

PHENYLEPHRINE HYDRO CHLO RIDE (UNII: 0 4JA59 TNSJ) (PHENYLEPHRINE -

UNII:1WS29 7W6 MV)

PHENYLEPHRINE

HYDROCHLORIDE

10 mg

in 10 mL

Inactive Ingredients

Ingredient Name

Stre ng th

PRO PYLPARABEN (UNII: Z8 IX2SC1OH)

METHYLPARABEN (UNII: A2I8 C7HI9 T)

GLYCERIN (UNII: PDC6 A3C0 OX)

WATER (UNII: 0 59 QF0 KO0 R)

ANHYDRO US CITRIC ACID (UNII: XF417D3PSL)

SUCRALO SE (UNII: 9 6 K6 UQ3ZD4)

Product Characteristics

Color

yello w (Light yello w)

S core

S hap e

S iz e

Flavor

TUTTI FRUTTI

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:58 552-138 -0 4

1 in 1 CARTON

10 /0 2/20 18

1

118 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt341

10 /0 2/20 18

Labeler -

Gil Pharmaceutical Corp (176826592)

Gil Pharmaceutical Corp

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Dextrum Labo rato ries Inc.

0 0 739 2322

ma nufa c ture (58 552-138 )

Revised: 3/2019

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