GILTUSS CHILDRENS COUGH AND CHEST CONGESTION- dextromethorphan hydrobromide, guaifenesin solution

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

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Active ingredient:
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS), GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)
Available from:
Gil Pharmaceutical Corp
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Purposes Cough Suppressant Expectorant Uses - temporarily relieves - cough due to minor throat and bronchial irritation associated with the common cold or inhaled irritants - the intensity of coughing - the impulse to cough to help your child get to sleep - helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive and drain bronchial tubes
Authorization status:
OTC monograph final
Authorization number:
58552-133-04

GILTUSS CHILDRENS COUGH AND CHEST CONGESTION- dextromethorphan

hydrobromide, guaifenesin 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 Children's Cough & Chest Congestion

Drug Facts

Active ingredients (in each 5 mL)

Dextromethorphan HBr, 10 mg

Guaifenesin, 100 mg

Purposes

Cough Suppressant

Expectorant

Uses

temporarily relieves

cough due to minor throat and bronchial irritation associated with the common cold or inhaled

irritants

the intensity of coughing

the impulse to cough to help your child get to sleep

helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive and drain

bronchial tubes

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 do not know if your child's prescription drug contains an MAOI, ask a

doctor or pharmacist before taking this product.

Ask a doctor before use if the child has

cough that occurs with too much phlegm (mucus)

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

Stop use and ask a doctor or pharmacist if the child has

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

cough comes back, or is accompanied by fever, rash, or persistent headache.

These could be signs of a serious condition.

When using this product

do not use more than directed.

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.

Directions

do not take more than 6 doses in any 24 hour period

use enclosed dosing cup

keep dosing cup for use with this product

mL = milliliters

children under 2 years

Consult a doctor

children 2 to under 6 years of age

2.5 mL every 4 hours

children 6 to under 12 years of age

5 mL every 4 hours

children 12 years and over

10 mL every 4 hours

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, D&C red #33, flavor, methylparaben, propylene glycol,

propylparaben, purified water, and sucrose

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

Children's

GILTUSS

COUGH & CHEST CONGESTION

ANTITUSSIVE AND EXPECTORANT

Non-Drowsy. Alcohol Free

COUGH AND COLD

CHEST CONGESTION

LIQUIFIES AND LOOSENS PHLEGM AND MUCUS

RASPBERRY FLAVOR

4FL OZ (118 mL)

GILTUSS CHILDRENS COUGH AND CHEST CONGESTION

dextromethorphan hydrobromide, guaifenesin solution

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:58 552-133

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

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

(DEXTROMETHORPHAN - UNII:7355X3ROTS)

DEXTROMETHORPHAN

HYDROBROMIDE

10 mg

in 5 mL

GUAIFENESIN (UNII: 49 5W7451VQ) (GUAIFENESIN - UNII:49 5W7451VQ)

GUAIFENESIN

10 0 mg

in 5 mL

Inactive Ingredients

Ingredient Name

Stre ng th

D&C RED NO . 3 3 (UNII: 9 DBA0 SBB0 L)

WATER (UNII: 0 59 QF0 KO0 R)

SUCRO SE (UNII: C151H8 M554)

Gil Pharmaceutical Corp

ANHYDRO US CITRIC ACID (UNII: XF417D3PSL)

PRO PYLPARABEN (UNII: Z8 IX2SC1OH)

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

METHYLPARABEN (UNII: A2I8 C7HI9 T)

Product Characteristics

Color

pink

S core

S hap e

S iz e

Flavor

RASPBERRY

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:58 552-133-0 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)

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 (58 552-133)

Revised: 3/2019

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