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

Giltuss HBP Cough and Chest Congestion by

Drug Labeling and Warnings

Giltuss HBP Cough and Chest Congestion by is a Otc medication manufactured, distributed, or labeled by Gil Pharmaceutical Corp, Dextrum Laboratories Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each 10 mL)

Dextromethorphan HBr, 20 mg

Guaifenesin, 200 mg

PURPOSE

Purposes

Cough Suppressant

Expectorant

INDICATIONS & USAGE

Uses

• temporarily relieves
• cough due to minor throat and bronchial irritation as may occur with the 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 cough more productive

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 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

• a cough with too much phlegm (mucus)
• a persistent or chronic cough such as occurs with smoking, chronic bronchitis, or emphysema

When using this product do not use more than directed.

Stop use and ask a doctor if

• 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 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.

DOSAGE & ADMINISTRATION

Directions

• do not exceed recommended dosage
• do not take more than 6 doses in any 24 hour period
• keep dosing cup for use with this product
• mL = milliliters

• adults and children 12 years & 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: Consult a doctor

SPL UNCLASSIFIED SECTION

Other information

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

INACTIVE INGREDIENT

Inactive ingredients Citric acid, D&C red #33, flavor, methylparaben, propylene glycol, propylparaben, purified water, and sucrose

QUESTIONS

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.

SPL UNCLASSIFIED SECTION

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

MANUFACTURED FOR

GIL PHARMACEUTICAL CORP.

PONCE, PUERTO RICO 00717-1565

PRINCIPAL DISPLAY PANEL

MAXIMUM STRENGTH

HBP GILTUSS®

COUGH & CHEST CONGESTION

ANTITUSSIVE AND EXPECTORANT

ALCOHOL FREE. NON-DROWSY

RELIEVES

• COUGH AND COLD
• CHEST CONGESTION
• LIQUIFIES AND LOOSENS PHLEGM AND MUCUS

RASPBERRY FLAVOR

4FL OZ (118 mL)

INGREDIENTS AND APPEARANCE

GILTUSS HBP COUGH AND CHEST CONGESTION 
dextromethorphan hydrobromide, guaifenesin solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58552-132
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
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
WATER (UNII: 059QF0KO0R)
SUCROSE (UNII: C151H8M554)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
METHYLPARABEN (UNII: A2I8C7HI9T)

Product Characteristics
Color	pink	Score
Shape		Size
Flavor	RASPBERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58552-132-04	1 in 1 CARTON	11/13/2018
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	11/13/2018

Labeler - Gil Pharmaceutical Corp (176826592)

Establishment
Name	Address	ID/FEI	Business Operations
Dextrum Laboratories Inc.		007392322	manufacture(58552-132)