GILTUSS PEDIATRIC- dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride solution/ drops 
Gil Pharmaceutical Corp

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Giltuss Pediatric

Active ingredients

(in each 1 mL)

Dextromethorphan HBr, 7.5 mg

Guaifenesin, 88 mg

Phenylephrine HCI, 2.5 mg

Purposes

Antitussive

Expectorant

Nasal Decongestant

Uses

  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
  • helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive
  • temporarily relieves nasal congestion due to a cold

Warnings

Do not use

  • 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 you have

  • a child who has heart disease, high blood pressure, thyroid disease, or diabetes unless directed by a doctor
  • a cough with too much phlegm (mucus)
  • a persistent or chronic cough such as occurs with asthma or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor

When using this product

  • Do not exceed recommended dosage

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur
  • cough lasts for more than 7 days, comes back, or occurs with fever, rash or headache that lasts. 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 accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

Directions

  • do not exceed recommended dosage
  • take every 6 - 8 hours
  • administer using the spill guard dispenser and syringe that's provided
children 6 to under 12 years of age2 mL
children 2 to 6 years of age1 mL
children under 2 years of ageConsult a doctor

Other information

  • Tamper evident: Do not use if safety seal is broken or missing
  • Store at controlled room temperature, between 15°- 30° C (59° - 86° F)

INSTRUCTIONS FOR USING THE ORAL LIQUID SPILL GUARD DISPENSER AND SYRINGE (INSTRUCCIONES PARA USAR EL "SPILL GUARD DISPENSER" Y LA JERINGUILLA PARA EL LIQUIDO ORAL)

1. Remove the child resistant cap and insert the Spill Guard Dispenser (B) into the bottle (A). Insert syringe (C) into Spill Guard Dispenser opening.

1. (Remueva la tapa resistente a niños. Introduzca en la botella (A) el "Spill Guard Dispenser" (B) Introduzca la jeringuilla (C) por la abertura del "Spill Guard Dispenser".)

Image for Step 1

2. Turn bottle with Spill Guard Dispenser and syringe upside down and withdraw the required amount.

2. (Invierta la botella con el "Spill Guard Dispenser" y la jeringuilla y extragia la cantidad requerida.)

Image for Step 2

3. Return bottle to upright position. Remove the syringe and administer the medicine. Clean the syringe for next use. Leave Spill Guard Dispenser in bottle and replace child resistant cap.

3. (Vuelva a invertir toda la unidad a su posición original. Remueva la jeringuilla y administre la medicina. Lave la jeringuilla para su próximo uso. Deje puesto el "Spill Guard Dispenser" en la botella y ciérrela nuevamente con la tapa resistente a niños.)

Image for Step 3

Inactive ingredients

Artificial grape and vanilla flavor, bitter mask, citric acid, grapeskin extract, menthol, monoammonium glycyrrhizinate, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose. Sodium citrate may be used to adjust pH.

Questions or comment?

Call 1-877-746-9114, Mon. -Fri. 8:00 am thru 5:00 pm EST. Call your doctor for medical advice in the event of side effects.


Rev. 323:01 6/10

Package/Label Principal Display Panel

Image of Carton - 60 mL

NDC 58552-121-02

GILTUSS PEDIATRIC®

NEW IMPROVED FORMULA

ANTITUSSIVE, EXPECTORANT, NASAL DECONGESTANT

Sugar Free & Alcohol Free

No Artificial Dyes

Easier Dosing for Children

Unique Dispenser for Exact Dosing

With Spill Guard Dispenser

Child Resistant Cap

Each 1 mL contains:

Dextromethorphan HBr..................................7.5 mg

Guaifenesin......................................................88 mg

Phenylephrine HCl..........................................2.5 mg

2 Fl. Oz. (60 mL)

MANUFACTURED FOR:

GIL PHARMACEUTICAL CORP.

PONCE, PUERTO RICO 00717-1565

GILTUSS PEDIATRIC 
dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58552-121
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE7.5 mg  in 1 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN88 mg  in 1 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
POLYETHYLENE GLYCOL 1450 (UNII: OJ4Z5Z32L4)  
MENTHOL (UNII: L7T10EIP3A)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
Product Characteristics
Colorpurple (clear, purple) Score    
ShapeSize
FlavorGRAPE (artificial grape flavor and grapeskin extract powder) , VANILLA (artificial vanilla flavor) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58552-121-021 in 1 CARTON10/19/200903/28/2019
160 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/19/200903/28/2019
Labeler - Gil Pharmaceutical Corp (176826592)
Establishment
NameAddressID/FEIBusiness Operations
Hi-Tech Pharmacal Co., Inc.101196749manufacture(58552-121)

Revised: 3/2019
 
Gil Pharmaceutical Corp