IGUALTUSS- dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid 
Alternative Pharmacal Corporation

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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Active Ingredients (in each 5 mL tsp.)              Purpose

Dextromethorphan HBr ............... 28 mg ................ Cough Suppressant

Guaifenesin .............................. 388 mg ................ Expectorant

Phenylephrine HCl ..................... 10 mg ................... Nasal Decongestant

Purpose 

Cough Suppressant

Expectorant

Nasal Decongestant

Warnings

Do not use if you are now 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 you are taking a prescription drug that contains an MAOI; ask your doctor or pharmacist before taking this product.

Ask a doctor before use if you have

Ask a doctor before use if you are taking sedatives, tranquilizers or drugs for depression or MAOI drugs.

Stop use and ask a doctor if

If pregnant or breast-feeding, ask a doctor before use.

Keep out of reach of children. In case of accidental overdose, seek advice of a doctor or contact a Poison Control Center right away.

Uses

Directions  Do not exceed more than 4 doses in 24 hours.

Adults and children over 12 years of age                   take 1 teaspoonful (5 mL) every 6-8 hours

Children 6 to under 12 years of age                          take 1/2 teaspoonful (2.5 mL) every 6-8 hours

Children under 6 years of age                                   consult a doctor before use

Inactive ingredients: Citric acid, FD&C Yellow #6, glycerin, menthol, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, and sucralose

Questions or comments? 1-786-507-1566

Monday-Friday 9:00AM -5:00PM

igualtuss

IGUALTUSS 
dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53163-106
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE28 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN388 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
SUCRALOSE (UNII: 96K6UQ3ZD4)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
MENTHOL (UNII: L7T10EIP3A)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
Product Characteristics
Color    Score    
ShapeSize
FlavorgrapeImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53163-106-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product03/01/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/01/2014
Labeler - Alternative Pharmacal Corporation (078528214)

Revised: 12/2020
Document Id: f2f48593-234d-400f-b3f5-eaf31f98ba5f
Set id: 5499be5e-aa88-4376-9a77-4cfa3a4c168f
Version: 4
Effective Time: 20201223
 
Alternative Pharmacal Corporation