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Mucus Relief Chest Congestion

Dosage form: tablet, film coated
Ingredients: GUAIFENESIN 400mg
Labeler: Rite Aid
NDC Code: 11822-0532

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.

Rite Aid 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 or bothersome 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
  • take with a full glass of water
  • adults and children 12 years of age and over: 1 tablet, every 4 hours. Do not take more than 6 tablets in 24 hours.
  • children under 12 years: do not use 

Other information
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number 

Inactive ingredients

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

Principal Display Panel

RITE AID®
PHARMACY

mucus relief
chest congestion
guaifenesin 400 mg
expectorant

relieves chest congestion
thins and loosens mucus

ACTUAL SIZE

IMMEDIATE RELEASE
30 TABLETS

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

50844      REV0812A53201

DISTRIBUTED BY:RITE AID
30 HUNTER LANE, CAMP HILL, PA 17011

Rite Aid 44-532

MUCUS RELIEF CHEST CONGESTION 
guaifenesin tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-0532
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN400 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 
HYPROMELLOSES 
MAGNESIUM STEARATE 
MALTODEXTRIN 
POLYETHYLENE GLYCOLS 
POVIDONES 
SILICON DIOXIDE 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
STEARIC ACID 
Product Characteristics
ColorBLUEScore2 pieces
ShapeROUNDSize13mm
FlavorImprint Code44;532
Contains    
Packaging
#Item CodePackage Description
1NDC:11822-0532-31 BLISTER PACK in 1 CARTON
110 TABLET, FILM COATED in 1 BLISTER PACK
2NDC:11822-0532-01 BOTTLE in 1 CARTON
260 TABLET, FILM COATED in 1 BOTTLE
3NDC:11822-0532-11 BOTTLE in 1 CARTON
330 TABLET, FILM COATED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34112/22/2005
Labeler - Rite Aid (014578892)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(11822-0532)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(11822-0532)

Revised: 11/2015
 
Rite Aid

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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