MUCUS RELIEF- guaifenesin tablet 
Sam's West 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.

----------

Simply Right 44-532

Active ingredient (in each immediate-release tablet)

 Guaifenesin 400 mg

Purpose

 Expectorant

Uses

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersom mucus and make coughs more productive

Warnings

Ask a doctor before use if you have

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

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 condition.

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 right away.

Directions

Other information

Inactive ingredients

FD&C blue #1 alluminum lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, silicon dioxide, sodium starch glycolate, stearic acid

Questions?

 To Report Adverse Drug Event Call: (800) 616-2471

Principal Display Panel

NDC 68196-532-06      chest congestion

SIMPLY RIGHT
Health Care

mucus relief
guaifenesin | expectorant

releives chest congestion, thins and loosens mucus

1 tablet dose
immediate release

200 tablets

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

50844     ORG051053206

Distributed by:
SAM"S West, Inc.
Bentonville, AR 72716

Simply Right 44-532

Simply Right 44-532

MUCUS RELIEF 
guaifenesin tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68196-532
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 400 mg
Inactive Ingredients
Ingredient Name Strength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POVIDONES (UNII: FZ989GH94E)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
Product Characteristics
Color BLUE Score 2 pieces
Shape ROUND Size 13mm
Flavor Imprint Code 44;532
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:68196-532-06 1 in 1 CARTON
1 200 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part341 12/22/2005
Labeler - Sam's West Inc (051957769)
Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 038154464 PACK(68196-532)
Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 832867894 MANUFACTURE(68196-532)

Revised: 10/2012
Document Id: 5ffce1f0-f84a-4367-b20f-05fedd1e6a62
Set id: 7f268ea3-5795-47e5-a0b4-0d324c4ce924
Version: 1
Effective Time: 20121004
 
Sam's West Inc