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

Giltuss Childrens Cough and Chest Congestion by

Drug Labeling and Warnings

Giltuss Childrens 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]

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Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each 5 mL)

Dextromethorphan HBr, 10 mg

Guaifenesin, 100 mg

PURPOSE

Purposes

Cough Suppressant

Expectorant

INDICATIONS & USAGE

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.

DOSAGE & ADMINISTRATION

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

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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, flavor, 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.

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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

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)

INGREDIENTS AND APPEARANCE

GILTUSS CHILDRENS COUGH AND CHEST CONGESTION 
dextromethorphan hydrobromide, guaifenesin solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58552-133
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 mg  in 5 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: 58552-133-04	1 in 1 CARTON	10/02/2018
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	10/02/2018

Labeler - Gil Pharmaceutical Corp (176826592)

Establishment
Name	Address	ID/FEI	Business Operations
Dextrum Laboratories Inc.		007392322	manufacture(58552-133)