Mucus Relief Cough and Congestion DM

Dosage form: tablet, coated
Ingredients: DEXTROMETHORPHAN HYDROBROMIDE 20mg, GUAIFENESIN 400mg
Labeler: Rite Aid
NDC Code: 11822-5330

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 44-533

Active ingredient (in each immediate-release tablet)

Dextromethorphan HBr 20 mg
Guaifenesin 400 mg

Purpose

Cough suppressant
Expectorant

Uses
  • temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive 

Warnings

Do not use
  •  if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psuchiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if
  • cough accompanied by too much phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

When using this product
  • do not use more than directed 

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-86º)
  • see end flap for expiration date and lot number 

Inactive ingredients

D&C yellow #10 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
cough and congestion DM
dextromethorphan HBr 20 mg
guaifenesin 400 mg

relieves cough and chest congestion
thins and loosens mucus

IMMEDIATE RELEASE
30 TABLETS

50844    REV0612A53311

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

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

Rite Aid 44-533

MUCUS RELIEF COUGH AND CONGESTION DM 
guaifenesin and dextromethorphan hbr tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-5330
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE20 mg
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN400 mg
Inactive Ingredients
Ingredient NameStrength
D&C YELLOW NO. 10 
HYPROMELLOSES 
MAGNESIUM STEARATE 
MALTODEXTRIN 
POLYETHYLENE GLYCOLS 
POVIDONES 
SILICON DIOXIDE 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
STEARIC ACID 
Product Characteristics
ColorYELLOWScoreno score
ShapeCAPSULESize17mm
FlavorImprint Code44;533
Contains    
Packaging
#Item CodePackage Description
1NDC:11822-5330-31 BLISTER PACK (1 BLISTER PACK) in 1 CARTON
110 TABLET, COATED (10 TABLET) in 1 BLISTER PACK
2NDC:11822-5330-01 BOTTLE, PLASTIC (1 BOTTLE) in 1 CARTON
230 TABLET, COATED (30 TABLET) in 1 BOTTLE, PLASTIC
3NDC:11822-5330-11 BOTTLE, PLASTIC (1 BOTTLE) in 1 CARTON
360 TABLET, COATED (60 TABLET) in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34112/31/2005
Labeler - Rite Aid (014578892)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(11822-5330)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837MANUFACTURE(11822-5330)

Revised: 10/2013
 
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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