RESFRIDOL ANTITUSSIVE- guaifenesin, dextromethorphan hbr suspension 
Laboratorios Alfa

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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Resfridol Antitussive

Drug Facts

Active ingredients and Purposes

Active ingredients (in each 10 mL)Purposes
Guaifenesin 200 mg ............................................................................Expectorant
Dextromethorphan HBr 30 mg..................................................Cough suppressant

Uses

Temporarily relieves common cold symptoms:

Warnings

Ask a doctor or pharmacist before 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 your prescription drug contains an MAOI.
  • have a persistent or chronic cough such as occurs with smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus)

Stop use and ask a doctor if

a cough persists for more than 7 days, tends to recur, or is accompanied by fever, rash or persistent headache. 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 accidental 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

Other information

Other information

Other information

Inactive ingredients

artificial flavors, citric acid, FD&C red no.40, sodium benzoate, sorbitol, sucralose, water

Questions?

+1-809-544-0222 (M-F) 9 AM to 5 PM Eastern or www.laboratoriosalfa.com

Principal Display Panel

Resfridol

Antitussive

Syrup

Dextromethorphan Hbr and Guaifenesin

4 fl oz (120mL)

Resfridol Antitussive

RESFRIDOL ANTITUSSIVE 
guaifenesin, dextromethorphan hbr suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72483-100
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE30 mg  in 10 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72483-100-041 in 1 BOX08/01/2019
1120 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/01/2019
Labeler - Laboratorios Alfa (815941244)

Revised: 7/2022
Document Id: e39d9051-ad31-7afc-e053-2995a90a6091
Set id: 908f70e0-706b-1234-e053-2a95a90ade84
Version: 3
Effective Time: 20220712
 
Laboratorios Alfa