CHILDRENS GILTUSS D- childrens giltuss d syrup 
Gil Pharmaceutical Corp

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Children's Giltuss-D
ALLERGY & CONGESTION
ANTIHISTAMINIC AND NASAL DECONGESTANT

Drug Facts

Active ingredients (in each 5 mL) Purpose

Chlorpheniramine maleate 1.75 mg .... Antihistamine

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

Uses

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

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).

Directions

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

Other information

Inactive ingredients

Citric Acid, Flavor, Glycerin, Methylparaben, Propylene Glycol, Propylparaben, Purified Water, Sodium Carboxymethylcellulose, 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.

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

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

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CHILDRENS GILTUSS D 
childrens giltuss d syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58552-148
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE1.75 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE5 mg
Inactive Ingredients
Ingredient NameStrength
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    
ShapeSize
FlavorTUTTI FRUTTIImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58552-148-041 in 1 CARTON04/11/2024
11 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01204/11/2024
Labeler - Gil Pharmaceutical Corp (176826592)

Revised: 4/2024
Document Id: 15e05a01-3156-4a1b-e063-6394a90ae2e1
Set id: cfc2493b-e99e-4b55-98a9-053f95d49844
Version: 1
Effective Time: 20240412
 
Gil Pharmaceutical Corp