GILTUSS DIABETIC COUGH AND COLD- dextromethorphan hydrobromide, guaifenesin solution

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

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Active ingredient:
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ), DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)
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 a common cold or inhaled irritants - the intensity of coughing - the impulse to cough to help you get to sleep - helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive and drain bronchial tubes
Authorization status:
OTC monograph final
Authorization number:
58552-134-04

GILTUSS DIABETIC COUGH AND COLD- 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.

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Giltuss Diabetic Cough and Cold

Drug Facts

Active ingredients (in each 10 mL)

Dextromethorphan HBr, 20 mg

Guaifenesin 200 mg

Purpos es

Cough Suppressant

Expectorant

Uses

temporarily relieves

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

the intensity of coughing

the impulse to cough to help you get to sleep

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

drain bronchial tubes

Warnings

Do not use

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 MAOl drug. If you do not know if your prescription drug contains an MAOI, ask a

doctor or pharmacist before taking this product.

When using this product do not use more than directed

Ask a doctor before use if you have

a cough with too much phlegm (mucus)

a persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis or emphysema

Stop use and ask a doctor if

cough lasts more than 7 days, comes back, or is accompanied by fever, rash or headache that lasts as

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 accidental overdose, get medical or professional help or

contact a Poison Control Center immediately.

Directions

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

keep dosing cup with product

mL = milliliters

Adults and children 12 years and over

10 mL every 4 hours

children 6 to under 12 years of age

5 mL every 4 hours

children 2 to under 6 years of age

2.5 mL every 4 hours

children under 2 years of age

Do not use

Other information

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

close cap tightly

SAVE CARTON FOR COMPLETE DRUG FACTS

Inactive ingredients: Citric acid, flavor, menthol, methylparaben, 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.

MANUFACTURED FOR

GIL PHARMACEUTICAL CORP.

PONCE, PUERTO RICO 00717-1565

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

PERSONS WITH DIABETES: CONSULT YOUR DOCTOR OR PHARMACIST BEFORE

USING ANY MEDICATION OR DIETARY SUPPLEMENT

THIS PRODUCT DOES NOT CONTAIN ANY MEDICATION TO IMPROVE OR RELIEVE

DIABETES

Giltuss® DIABETIC

COUGH & COLD

RELIEVES

COUGH AND COLD

CHEST CONGESTION

LIQUIFIES AND LOOSENS PHLEGM AND MUCUS

SAFE FOR PEOPLE WITH DIABETES

GRAPE FLAVOR

4 FL OZ (118 mL)

GILTUSS DIABETIC COUGH AND COLD

dextromethorphan hydrobromide, guaifenesin solution

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:58 552-134

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

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

GUAIFENESIN

20 0 mg

in 10 mL

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

(DEXTROMETHORPHAN - UNII:7355X3ROTS)

DEXTROMETHORPHAN

HYDROBROMIDE

20 mg

in 10 mL

Inactive Ingredients

Ingredient Name

Stre ng th

PRO PYLPARABEN (UNII: Z8 IX2SC1OH)

ANHYDRO US CITRIC ACID (UNII: XF417D3PSL)

METHYLPARABEN (UNII: A2I8 C7HI9 T)

MENTHO L (UNII: L7T10 EIP3A)

Gil Pharmaceutical Corp

WATER (UNII: 0 59 QF0 KO0 R)

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

SUCRALO SE (UNII: 9 6 K6 UQ3ZD4)

Product Characteristics

Color

S core

S hap e

S iz e

Flavor

GRAPE

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:58 552-134-0 4

1 in 1 CARTON

10 /17/20 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 /17/20 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 (58 552-134)

Revised: 3/2019

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