GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE- guaifenesin and dextromethorphan hydrobromide tablet 
APNAR PHARMA LP

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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Guaifenesin and Dextromethorphan Hydrobromide Tablets 400 +20 mg

Caution: do not use if imprinted seal under cap is broken or missing

Drug Facts

Active Ingredients (per tablet)

Guaifenesin USP...................................... 400 mg

Dextromethorphan Hydrobromide USP...... 20 mg

Purpose

Expectorant

Cough suppressant

Uses:

WARNINGS

Do not use

Ask a doctor before use if you have

Stop use and ask a doctor if

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

Keep out of reach of children

In case of overdose, get medical help or contact poison control center immediately

Directions

Do not exceed 6 doses in 24 hour period or as directed by a doctor

Other Information

Inactive Ingredients

Microcrystalline cellulose, Croscarmellose sodium, Povidone, silicon dioxide, magnesium stearate

Questions or concerns?

Distributed by:

APNAR PHARMA LP

CHINO, CA, 91710

Rev.: 04/2022

APNAR PHARMA LP

NDC 24689-123-01

Guaifenesin and Dextromethorphan Hydrobromide Tablets 400 + 20mg- 20s tablets

Guaifenesin and Hbr tablets 400+20mg- 20s tablets

APNAR PHARMA LP

NDC 24689-123-02

Guaifenesin and Dextromethorphan Hydrobromide Tablets 400 + 20mg- 500s tablets

Guaifenesin and Hbr tablets 400+20mg- 500s tablets

GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE 
guaifenesin and dextromethorphan hydrobromide tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24689-123
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POVIDONE K30 (UNII: U725QWY32X)  
WATER (UNII: 059QF0KO0R)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
Product Characteristics
ColorwhiteScore2 pieces
ShapeCAPSULESize18mm
FlavorImprint Code LT13
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:24689-123-0120 in 1 BOTTLE; Type 0: Not a Combination Product12/30/2022
2NDC:24689-123-02500 in 1 BOTTLE; Type 0: Not a Combination Product12/30/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34112/30/2022
Labeler - APNAR PHARMA LP (079568229)
Establishment
NameAddressID/FEIBusiness Operations
Apnar Pharma Private Limited876730408analysis(24689-123) , manufacture(24689-123)
Establishment
NameAddressID/FEIBusiness Operations
APNAR PHARMA LLP118530917pack(24689-123) , label(24689-123)

Revised: 1/2023
Document Id: f17dcc88-303d-4e1f-e053-2a95a90ae08d
Set id: e22b0c01-390f-2743-e053-2995a90aee29
Version: 3
Effective Time: 20230104
 
APNAR PHARMA LP