GILTUSS MULTISYMPTOM COLD AND FLU- acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydroch

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

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Active ingredient:
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U), PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV), DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS), ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)
Available from:
Giltuss Pharmaceutical Corp
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Purposes Pain reliever/fever reducer Antihistamine Cough Suppressant Nasal decongestant Uses - temporarily relieves: - minor aches and pains - headache - minor sore throat pain - runny nose - itchy nose or throat - sneezing - itchy watery eyes due to hay fever - nasal and sinus congestion - cough due to minor throat and bronchial irritation as may occur with a cold - temporarily reduces fever Do not use - if you are allergic to acetaminophen or any inactive ingredient in this product - with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. - 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. Stop use and ask a doctor if - you
Authorization status:
OTC monograph final
Authorization number:
58552-136-04

GILTUSS MULTISYMPTOM COLD AND FLU- acetaminophen, chlorpheniramine maleate,

dextromethorphan hydrobromide, phenylephrine hydrochloride solution

Giltuss 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.

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Giltuss Multi-Symptom Cold & Flu

Drug Facts

Active ingredients (in each 10 mL)

Acetaminophen 650 mg

Chlorpheniramine maleate 4 mg

Dextromethorphan hydrobromide 13 mg

Phenylephrine hydrochloride 10 mg

Purposes

Pain reliever/fever reducer

Antihistamine

Cough Suppressant

Nasal decongestant

Uses

temporarily relieves:

minor aches and pains

headache

minor sore throat pain

runny nose

itchy nose or throat

sneezing

itchy watery eyes due to hay fever

nasal and sinus congestion

cough due to minor throat and bronchial irritation as may occur with a cold

temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if:

adult takes more than 6 doses in 24 hours, which is the maximum daily amount

child takes more than 5 doses in 24 hours

taken with other drugs containing acetaminophen

adult has 3 or more alcoholic drinks every day while using this product

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

skin reddening

blisters

rash

hives

facial swelling

asthma (wheezing)

shock

If a skin reaction occurs, stop use and seek medical help right away.

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or

followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use

if you are allergic to acetaminophen or any inactive ingredient in this product

with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure

whether a drug contains acetaminophen, ask a doctor or pharmacist.

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 or pharmacist before use if the user has

liver disease

heart disease

high blood pressure

thyroid disease

diabetes

glaucoma

a breathing problem such as chronic bronchitis

cough that occurs with too much phlegm (mucus)

chronic cough that lasts such as occurs with smoking, asthma, or emphysema

trouble urinating due to enlargement of the prostate gland

Ask a doctor or pharmacist before use if the user is

taking the blood thinning drug warfarin

taking sedatives or tranquilizers

When using this product

do not exceed recommended dosage

marked drowsiness may occur

excitability may occur, especially in children

avoid alcoholic drinks

alcohol, sedatives, and tranquilizers may increase drowsiness

be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

you get nervousness, dizzyness or sleeplessness

pain, nasal congestion, or cough gets worse or lasts more than 7 days

fever gets worse or lasts more than 3 days

redness or swelling is present

new symptoms occur

cough comes back or occurs with fever, rash or headache that lasts.

These could be signs of a serious condition.

If pregnant or breast-feeding, ask a health professional before use.

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

Center right away. Quick medical attention is critical for adults as well as for children even if you do

not notice any signs or symptoms.

Directions

do not give more than directed

use enclosed dosing cup

keep dosing cup for use with this product

mL = milliliter

adults and children 12 years and over

10 mL every 4-6 hours, not to exceed 6 doses in 2 hours

children 6 to under 12 years of age

5 mL every 4-6 hours, not to exceed 5 doses in 24 hours

children under 6 years of age

Do not use

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, disodium EDTA, flavor, glycerin, methylparaben, polyethylene glycol,

propylene glycol, 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

MAXIMUM STRENGTH

Giltuss® MULTI-SYMPTOM

COLD & FLU

ANALGESIC, ANTITUSSIVE, ANTIHISTAMINE & NASAL DECONGESTANT

ALCOHOL FREE. SODIUM FREE. SUGAR FREE. DYE FREE

RELIEVES

FEVER, HEADACHE AND BODY ACHES

COUGH AND COLD

SNEEZING

RUNNY NOSE

ITCHY AND WATERY EYES

STUFFY NOSE

SINUS PRESSURE

STRAWBERRY FLAVOR

4FL OZ (118 mL)

GILTUSS MULTISYMPTOM COLD AND FLU

acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride solution

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:58 552-136

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

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

UNII:1WS29 7W6 MV)

PHENYLEPHRINE

HYDROCHLORIDE

10 mg

in 10 mL

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

(DEXTROMETHORPHAN - UNII:7355X3ROTS)

DEXTROMETHORPHAN

HYDROBROMIDE

13 mg

in 10 mL

ACETAMINO PHEN (UNII: 36 2O9 ITL9 D) (ACETAMINOPHEN - UNII:36 2O9 ITL9 D)

ACETAMINOPHEN

6 50 mg

in 10 mL

Inactive Ingredients

Ingredient Name

Stre ng th

PO LYETHYLENE GLYCO L, UNSPECIFIED (UNII: 3WJQ0 SDW1A)

ANHYDRO US CITRIC ACID (UNII: XF417D3PSL)

PRO PYLPARABEN (UNII: Z8 IX2SC1OH)

GLYCERIN (UNII: PDC6 A3C0 OX)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

WATER (UNII: 0 59 QF0 KO0 R)

SUCRALO SE (UNII: 9 6 K6 UQ3ZD4)

EDETATE DISO DIUM (UNII: 7FLD9 1C8 6 K)

METHYLPARABEN (UNII: A2I8 C7HI9 T)

Product Characteristics

Color

yello w (Light yello w)

S core

S hap e

S iz e

Flavor

STRAWBERRY

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:58 552-136 -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 -

Giltuss Pharmaceutical Corp (176826592)

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 (58 552-136 )

Giltuss Pharmaceutical Corp

Revised: 3/2019

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