GUAIFENESIN- guaifenesin 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 Tablets 400 mg

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

Drug Facts
Active Ingredient (per tablet)
Guaifenesin USP............. 400 mg

Purpose
Expectorant

Use

Warnings


Ask doctor before use if you have

Stop use and ask a doctor if

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 immediately.

Directions

Do not exceed 6 doses in a 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 : 24689-122-01

Guaifenesin Tablets 400mg-20's Tablets

Guaifenesin Tablets 400mg_20s Tablets

APNAR PHARMA LP

NDC : 24689-122-02

Guaifenesin Tablets 400mg-500's Tablets

Guaifenesin Tablets 400mg_500s

GUAIFENESIN 
guaifenesin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24689-122
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
POVIDONE K30 (UNII: U725QWY32X)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Colorwhite (White to off White color) Score2 pieces
ShapeROUNDSize13mm
FlavorImprint Code LT;12
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:24689-122-0120 in 1 BOTTLE; Type 0: Not a Combination Product12/30/2022
2NDC:24689-122-02500 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(24689-122) , manufacture(24689-122)
Establishment
NameAddressID/FEIBusiness Operations
APNAR PHARMA LLP118530917pack(24689-122) , label(24689-122)

Revised: 1/2023
Document Id: f17dd3fb-510e-011b-e053-2a95a90a57e4
Set id: e217672e-ba0a-e79e-e053-2a95a90a6cd1
Version: 3
Effective Time: 20230104
 
APNAR PHARMA LP