GILTUSS CHILDRENS MULTISYMPTOM COLD AND FLU- acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride solution 
Giltuss Pharmaceutical Corp

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Giltuss Children's Multi-Symptom Cold & Flu

Drug Facts

Active ingredients (in each 5 mL)

Acetaminophen 325 mg

Chlorpheniramine maleate 2 mg

Dextromethorphan HBr 6.5 mg

Phenylephrine HCl 5 mg

Purposes

Pain reliever/fever reducer

Antihistamine

Cough Suppressant

Nasal decongestant

Uses

Warnings

Liver warning:This product contains acetaminophen. Severe liver damage may occur if your child takes:

Allergy alert:Acetaminophen may cause severe skin reactions. Symptoms may include:

If a skin reaction occurs, stop use and seek medical help right away.

Sore throat warning:If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use

Ask a doctor or pharmacist before use if the child has

Ask a doctor or pharmacist before use if the child is

When using this product

Stop use and ask a doctor if

These could 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. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

children under 6 years of ageDo not use
children 6 to under 12 years of age5 mL every 4-6 hours, not to exceed 5 doses in 24 hours
children 12 years and over10 mL every 4-6 hours, not to exceed 6 doses in 24 hours

Other information

Inactive ingredients

Citric acid, disodium EDTA, flavor, glycerin, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water and 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.

Tamper evident: do not use if safety seal is broken or missing

MANUFACTURED FOR

GIL PHARMACEUTICAL CORP.

PONCE, PUERTO RICO 00717-1565

Children's

Giltuss® MULTI-SYMPTOM

COLD & FLU

ANALGESIC, ANTITUSSIVE, ANTIHISTAMINE & NASAL DECONGESTANT

Alcohol Free. Sodium Free. Sugar Free. Dye Free

STRAWBERRY FLAVOR

4FL OZ (118 mL)

58552-137 Child Multisymptom

GILTUSS CHILDRENS MULTISYMPTOM COLD AND FLU 
acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58552-137
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE2 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE6.5 mg  in 5 mL
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
Product Characteristics
Coloryellow (Light yellow) Score    
ShapeSize
FlavorSTRAWBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58552-137-041 in 1 CARTON10/02/2018
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01210/02/2018
Labeler - Giltuss Pharmaceutical Corp (176826592)
Establishment
NameAddressID/FEIBusiness Operations
Dextrum Laboratories Inc007392322manufacture(58552-137)

Revised: 10/2023
Document Id: 0874fce4-0e32-ed3b-e063-6294a90adb7a
Set id: 852c8cd6-271f-0fa8-e053-2991aa0ab179
Version: 4
Effective Time: 20231024
 
Giltuss Pharmaceutical Corp