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Mucus Relief Severe Congestion and Cold Max Maximum Strength

Dosage form: tablet, film coated
Ingredients: ACETAMINOPHEN 325mg, DEXTROMETHORPHAN HYDROBROMIDE 10mg, GUAIFENESIN 200mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: Rite Aid Corporation
NDC Code: 11822-0617

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 44-617

Active ingredients
(in each caplet)

Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer
Cough suppressant
Expectorant
Nasal decongestant 

Uses
  • temporarily relieves these common cold and flu symptoms:
    • nasal congestion
    • cough
    • headache
    • minor aches and pains
  • temporarily reduces fever
  • temporarily promotes nasal and/or sinus drainage
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

  • more than 12 caplets in 24 hours, which is the maximum daily amount
  • 3 or more alcoholic drinks every day while using this product
  • with other drugs containing acetaminophen

Do not use
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • if you are now taking a monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you don't know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have
  • liver disease
  • diabetes
  • heart disease
  • high blood pressure
  • thyroid disease
  • trouble urinating due to an enlarged prostate gland
  • persistent or chronic cough  such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough that occurs with too much phlegm (mucus)

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin.

When using this product

do not exceed the recommended dosage. 

Stop use and ask a doctor if
  • new symptoms occur
  • pain, nasal congestion, or cough gets worse or lasts more than 7 days
  • redness or swelling is present
  • nervousness, dizziness, or sleeplessness occur
  • cough comes back or occurs with rash or headache that lasts
  • fever gets worse or lasts more than 3 days

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.

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.  

Directions
  • do not take more than directed
    (see overdose warning)
  • do not take more than 12 caplets in any 24-hour period
  • adults and children 12 years and older: take 2 caplets every 4 hours
  • children under 12 years of age: do not use

Other information
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • use by expiration date on package

Inactive ingredients

corn starch, crospovidone, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silica gel, sodium starch glycolate, stearic acid, talc, titanium dioxide 

Questions or comments?

1-800-426-9391

Principal display panel

RITE AID®
PHARMACY

*Compare to the active ingredients in Maximum Strength Mucinex® FAST-MAX™ Severe Congestion & Cold

MAXIMUM STRENGTH

mucus relief
severe congestion
& cold max

acetaminophen, dextromethorphan HBr
guaifenesin, phenylephrine HCl

pain reliever/fever reducer, cough suppressant,
expectorant, nasal decongestant

relieves nasal &
chest congestion
thins & loosens mucus
relieves headache
& fever
controls cough

for ages 12+

20 CAPLETS

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

*This product is not manufactured or distributed by Reckitt Benckiser LLC, owner of the registered trademark Maximum Strength Mucinex® FAST-MAX™ Severe Congestion & Cold.

50844     REV0313A61709

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

IF YOU'RE NOT SATISFIED,
WE'LL HAPPILY REFUND YOUR MONEY.

 

Rite Aid 44-617


MUCUS RELIEF SEVERE CONGESTION AND COLD MAX  MAXIMUM STRENGTH
acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-0617
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE10 mg
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN200 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
CROSPOVIDONE 
FD&C RED NO. 40 
FD&C YELLOW NO. 6 
MAGNESIUM STEARATE 
MALTODEXTRIN 
TITANIUM DIOXIDE 
TALC 
POVIDONE 
STEARIC ACID 
Product Characteristics
ColorREDScoreno score
ShapeOVALSize19mm
FlavorImprint Code44;617
Contains    
Packaging
#Item CodePackage Description
1NDC:11822-0617-92 BLISTER PACK in 1 PACKAGE
110 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34104/07/2013
Labeler - Rite Aid Corporation (014578892)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(11822-0617)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(11822-0617)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(11822-0617)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837PACK(11822-0617)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088PACK(11822-0617)

Revised: 07/2017
 
Rite Aid Corporation

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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