CHILDRENS GILTUSS D syrup

Childrens Giltuss D by

Drug Labeling and Warnings

Childrens Giltuss D by is a Otc medication manufactured, distributed, or labeled by Gil Pharmaceutical Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients (in each 5 mL) Purpose

Chlorpheniramine maleate 1.75 mg .... Antihistamine

Phenylephrine HCl 5 mg ................ Nasal decongestant

PURPOSE

INDICATIONS & USAGE

Uses

Temporarily relieves these Symptoms due to hay fever (allergic rhinitis) or other upper-respiratory allergies:

• runny nose
• Sneezing
• Itchy, watery eyes
• nasal congestion
• itching of the nose or throat
• sinus congestion and pressure

WARNINGS

Warnings

Do not use

• to sedate a child or to make a child sleepy
• if the child 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if the child has

• heart disease
• high blood pressure
• thyroid disease
• diabetes
• trouble urinating due to an enlarged prostate gland
• glaucoma
• a breathing problem or persistent or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Ask a doctor or pharmacist before use if the child is

• taking sedatives or tranquilizers

When using this product

• do not use more than directed
• may cause drowsiness
• avoid alcoholic beverages
• alcohol, sedatives, and tranquilizers may increase drowsiness
• avoid alcoholic drinks
• be careful when driving a motor vehicle or operating machinery
• excitability may occur, especially in children

Stop use and ask a doctor if

• if the child gets nervous, dizzy, or sleepless
• symptoms do not get better within 7 days or are accompanied by fever

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 (1-800-222-1222).

DOSAGE & ADMINISTRATION

Directions

• not take more than 6 doses in any 24-hour period
• use enclosed dosing cup
• keep dosage cup for use with this product
• mL = milliliter

• Children under 6 years of age:

  Consult a Doctor

• children 6 to under 12 years of age:

  5 mL every 4 hours

• Adults and children 12 years and over:

  10 mL every 4 hours

STORAGE AND HANDLING

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, Glycerin, Methylparaben, Propylene Glycol, Propylparaben, Purified Water, Sodium Carboxymethylcellulose, 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.

Label revised: 04/24

MANUFACTURED FOR
GIL PHARMACEUTICAL CORP.
PONCE, PUERTO RICO 00717-1565

PRINCIPAL DISPLAY PANEL

Children's Giltuss-D ALLERGY & CONGESTION - NDC: 58552-148-04 - Bottle Label

Children's Giltuss-D ALLERGY & CONGESTION - NDC: 58552-148-04 - Carton Label

INGREDIENTS AND APPEARANCE

CHILDRENS GILTUSS D 
childrens giltuss d syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58552-148
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	1.75 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE	5 mg

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID ACETATE (UNII: DSO12WL7AU)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color		Score
Shape		Size
Flavor	TUTTI FRUTTI	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58552-148-04	1 in 1 CARTON	04/11/2024
1		1 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 Drug	M012	04/11/2024

Labeler - Gil Pharmaceutical Corp (176826592)