MUCUS RELIEF- guaifenesin tablet, extended release 
KROGER COMPANY

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Kroger Guaifenesin Extended Release Tablets 600 mg

Drug Facts

Active ingredient (in each extended-release tablet)

Guaifenesin, USP 600 mg

Purpose

Expectorant

Uses

Warnings

Do not use

  • for children under 12 years of age

Ask a doctor before use if you have

  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough accompanied by too much phlegm (mucus)

Stop use and ask a doctor if

  • cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.

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 (1-800-222-1222) right away.

Directions

Other information

Inactive ingredients colloidal silicon dioxide, copovidone, FD&C blue no. 1 aluminum lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone (K-30), sodium starch glycolate, stearic acid.

Questions or comments? Call 1-800-632-6900

guaifensin-600mg-20s-ifc

MUCUS RELIEF 
guaifenesin tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41226-723
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN600 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y)  
POVIDONE K30 (UNII: U725QWY32X)  
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)  
COPOVIDONE K25-31 (UNII: D9C330MD8B)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
Colorwhite (Blue and White) Scoreno score
ShapeOVALSize16mm
FlavorImprint Code 42
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41226-723-021 in 1 CARTON05/21/2024
120 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21778005/21/2024
Labeler - KROGER COMPANY (006999528)
Registrant - TIME CAP LABORATORIES, INC. (037052099)
Establishment
NameAddressID/FEIBusiness Operations
MARKSANS PHARMA LIMITED925822975manufacture(41226-723)

Revised: 5/2024
Document Id: 18f142ab-0f3b-7a7b-e063-6294a90a960a
Set id: 100f59fb-f9e7-5acb-e063-6394a90af450
Version: 2
Effective Time: 20240521
 
KROGER COMPANY