GUAIFENESIN- guaifenesin tablet 
APNAR PHARMA LP

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Guaifenesin Tablets 400 mg

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

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

A persistent cough may be a sign of a serious condition

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 a 24 hour period or as directed by a doctor

Other Information

Store at 15°-30°C (59°-86°F)

Inactive Ingredients

Maltodextrin, Povidone, Silicon dioxide and Stearic acid

Questions or concerns?

Manufactured by:

APNAR PHARMA LLP

East Windsor, NJ 08520

Made in USA

Rev.: 05/2022

NDC 24689-144-01

Guaifenesin Tablets 400 mg

Expectorant

100 Tablets

Guaifenesin Tablets 400 mg - Label - 100s

GUAIFENESIN 
guaifenesin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24689-144
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg
Inactive Ingredients
Ingredient NameStrength
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
POVIDONE (UNII: FZ989GH94E)  
Product Characteristics
ColorwhiteScore2 pieces
ShapeROUND (Round shaped standard concave) Size10mm
FlavorImprint Code A;G1
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:24689-144-01100 in 1 BOTTLE; Type 0: Not a Combination Product08/05/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01208/05/2022
Labeler - APNAR PHARMA LP (079568229)
Establishment
NameAddressID/FEIBusiness Operations
INVAHEALTH INC116840615label(24689-144) , pack(24689-144)
Establishment
NameAddressID/FEIBusiness Operations
APNAR PHARMA LLP118530917manufacture(24689-144) , analysis(24689-144) , pack(24689-144)

Revised: 10/2023
Document Id: 0835c630-aaf2-b231-e063-6394a90a46c7
Set id: e5004c10-3877-c199-e053-2a95a90aa8ac
Version: 2
Effective Time: 20231021
 
APNAR PHARMA LP