GILTUSS CHILDRENS COUGH AND COLD- dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride solution

Giltuss Childrens Cough and Cold by

Drug Labeling and Warnings

Giltuss Childrens Cough and Cold 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 2.5 mL)

Dextromethorphan HBr 7.5 mg

Guaifenesin 150 mg

Phenylephrine HCI 5 mg

PURPOSE

Purposes

Cough Suppressant

Expectorant

Nasal decongestant

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

Warnings

Do not use

• to sedate a child or make a child sleepy
• in a child who is 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 giving this product.

Ask a doctor before use if the child has

• heart disease
• high blood pressure
• thyroid disease
• diabetes
• glaucoma
• cough that occurs with too much phlegm (mucus)
• a breathing problem or persistent or chronic cough that lasts such as occurs with asthma or chronic bronchitis

Ask a doctor or pharmacist before use if the child is

• taking any other oral nasal decongestant or stimulant
• taking sedatives, tranquilizers

• Stop use and ask a doctor if
• nervousness, dizziness, or sleepless occurs
• symptoms do not get better within 7 days or are accompanied by fever
• cough lasts more than 7 days, comes back, or occurs with fever, rash or persistant headache

These can 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.

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

• children under 2 years: Consult a doctor
• children 2 to under 6 years of age: 1.25 mL every 4 hours
• children 6 to 12 years of age: 2.5 mL every 4 hours
• children 12 years and over: 5 mL every 4 hours

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Other information

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

INACTIVE INGREDIENT

Inactive ingredients

citric acid, flavor, glycerin, hydroxyethylcellulose, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sorbitol solution, and sucralose.

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 & COLD

ANTITUSSIVE, EXPECTORANT, NASAL DECONGESTANT

Alcohol Free. Sugar Free. Dye Free.

• COUGH AND COLD
• CHEST CONGESTION
• STUFFY NOSE
• NASAL CONGESTION
• LOOSEN PHLEGM AND MUCUS
• SINUS PRESSURE

CHERRY FLAVOR

4 FL OZ (118 mL)

INGREDIENTS AND APPEARANCE

GILTUSS CHILDRENS COUGH AND COLD 
dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58552-131
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	7.5 mg  in 2.5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	150 mg  in 2.5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg  in 2.5 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
METHYLPARABEN (UNII: A2I8C7HI9T)
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) (UNII: S38J6RZN16)
GLYCERIN (UNII: PDC6A3C0OX)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58552-131-04	1 in 1 CARTON	11/07/2018
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	11/07/2018

Labeler - Gil Pharmaceutical Corp (176826592)

Establishment
Name	Address	ID/FEI	Business Operations
Dextrum Laboratories Inc.		007392322	manufacture(58552-131)