PULMOVAC- guaifenesin, dextromethorphan hbr liquid 
Menper Distributors, Inc.

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)

Guaifenesin 100 mg…………………………............Expectorant

Dextromethorphan HBR 10 mg…………………….Cough suppressant

Expectorant

Cough Suppresant

Uses

Warnings Do not exceed recommended dosage.

A persistent cough may be a sign of a serious condition. If cough persists more than one week, tends to recur, or is accompanied by fever, rash or persistent headache, consult a doctor.

Do not use:

Keep out of reach of children

If you are pregnant or breast-feeding,ask a health professional before use. In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Directions

Adults and children over 12 years……………..2 teaspoonfuls (10 mL) every 4 hours

Children 6 to under 12 years of age………….1 teaspoonful (5 mL) every 4 hours

Children 2 to under 6 years of age………….1/2 teaspoonful (2.5 mL) every 4 hours

Children under 2 years of age……………………consult your physician

Other Information

Inactive Ingredients

citric acid, FD&C red #33, glycerin, methylparaben, propylene glycol, propylparaben, raspberry flavor, sucrose, water

Pulmovac Label

PULMOVAC 
guaifenesin, dextromethorphan hbr liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53145-031
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
GLYCERIN (UNII: PDC6A3C0OX)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
RASPBERRY (UNII: 4N14V5R27W)  
SUCROSE (UNII: C151H8M554)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53145-031-061 in 1 CARTON
1180 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34102/21/2012
Labeler - Menper Distributors, Inc. (101947166)

Revised: 8/2013
Document Id: c4d0389a-acfc-4fd0-a45b-7e7d90e26da0
Set id: 9ae63e5d-cc2c-4186-aa9d-405f5fa55705
Version: 3
Effective Time: 20130828
 
Menper Distributors, Inc.