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Daytime Mucus Relief Severe Cold/Nighttime Mucus Relief Cold and Flu

Medically reviewed on March 23, 2017

Dosage form: kit
Ingredients: ACETAMINOPHEN 325mg, DEXTROMETHORPHAN HYDROBROMIDE 10mg, GUAIFENESIN 200mg, PHENYLEPHRINE HYDROCHLORIDE 5mg; ACETAMINOPHEN 325mg, DIPHENHYDRAMINE HYDROCHLORIDE 25mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: Wal-Mart Stores Inc
NDC Code: 49035-997

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.

Equate 44-617544

Active ingredients (in each caplet)
(Daytime Severe Cold)

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

Purpose

Pain reliever/fever reducer
Cough suppressant
Expectorant
Nasal decongestant

Active ingredients (in each caplet)
(Nighttime Cold & Flu)

Acetaminophen 325 mg
Diphenhydramine HCl 25 mg
Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer
Antihistamine
Nasal decongestant

Uses
  • temporarily relieves these common cold and flu symptoms:
    • headache
    • minor aches and pains
    • nasal congestion
    • sore throat
    • cough (Daytime Severe Cold only)
    • runny nose and sneezing (Nighttime Cold & Flu only)
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive (Daytime Severe Cold only)
  • temporarily reduces fever

Warnings

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

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

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

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 prescription 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 do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
  • if you have ever had an allergic reaction to this product or any of its ingredients
  • for children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin (Nighttime Cold & Flu only)

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

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers (Nighttime Cold & Flu only)

When using this product
  • do not exceed recommended dosage
  • excitability may occur, especially in children (Nighttime Cold & Flu only)
  • marked drowsiness may occur (Nighttime Cold & Flu only)
  • avoid alcoholic drinks (Nighttime Cold & Flu only)
  • alcohol, sedatives, and tranquilizers may increase drowsiness (Nighttime Cold & Flu only)
  • be careful when driving a motor vehicle or operating machinery (Nighttime Cold & Flu only)

Stop use and ask a doctor if
  • nervousness, dizziness, or sleeplessness occur
  • pain, nasal congestion, or cough gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • persistent cough lasts for more than one week, tends to recur, or is accompanied by fever, rash, or persistent headache (Daytime Severe Cold only)

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 use more than directed (see overdose warning)
  • adults and children 12 years and over
    • take 2 caplets every 4 hours
    • do not take more than 12 caplets in 24 hours
  • children under 12 years: do not use

Other information
  • TAMPER EVIDENT: DO NOT USE ID 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 (Daytime Severe Cold)

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

Inactive ingredients (Nighttime Cold & Flu)

corn starch, croscarmellose sodium, crospovidone, FD&C blue #1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, silica gel, stearic acid, titanium dioxide, triacetin

Questions or comments?

1-888-287-1915

Principal Display Panel

equate™

NDC 49035-997-01

Compare to
Mucinex®
FAST-MAX®
DAY TIME Severe
Cold and NIGHT TIME
Cold & Flu
Active
ingredients*

Daytime

Mucus Relief
Severe Cold

Acetaminophen-
Pain Reliever/Fever Reducer,

Dextromethorphan HBr-
Cough Suppressant,

Guaifenesin - Expectorant,

Phenylephrine HCl -
Nasal Decongestant

• Relieves pain, fever, sore
  throat and head and chest
  congestion

• Thins & loosens mucus

• Controls cough

20
DAYTIME
CAPLETS 
      Actual Size

Nighttime

Mucus Relief
Cold & Flu

Acetaminophen -
Pain Reliever/Fever Reducer,

Diphenhydramine HCl -
Antihistamine,

Phenylephrine HCl -
Nasal Decongestant

• Relieves pain, fever, sore
  throat and nasal congestion

• Relieves runny nose &
  sneezing

Ages 12+

Pseudoephedrine Free

10
NIGHTTIME
CAPLETS  
       Actual Size

C-2203-617544-01-INS
50844      REV0414A61754401

Satisfaction guaranteed - for questions
or comments please call 1-888-287-1915.

Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716

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

50844                   REV0414A61754401

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

Equate 44-617544

DAYTIME MUCUS RELIEF SEVERE COLD/NIGHTTIME MUCUS RELIEF COLD AND FLU 
acetaminophen, dextromehtorphan hbr, guaifenesin, phenylephrine hcl/acetaminophen, diphenhydramine hcl, phenylephrine hcl kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-997
Packaging
#Item CodePackage Description
1NDC:49035-997-011 KIT in 1 CARTON
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 12 BLISTER PACK 20 
Part 21 BLISTER PACK 10 
Part 1 of 2
MUCUS RELIEF SEVERE COLD  DAYTIME
acetaminophen, dextromehtorphan hbr, guaifenesin, phenylephrine hcl tablet, film coated
Product Information
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 
FD&C RED NO. 40 
FD&C YELLOW NO. 6 
MAGNESIUM STEARATE 
MALTODEXTRIN 
MICROCRYSTALLINE CELLULOSE 
POVIDONE, UNSPECIFIED 
STEARIC ACID 
TALC 
TITANIUM DIOXIDE 
CROSPOVIDONE, UNSPECIFIED 
POLYETHYLENE GLYCOL, UNSPECIFIED 
POLYVINYL ALCOHOL, UNSPECIFIED 
SILICON DIOXIDE 
Product Characteristics
ColorREDScoreno score
ShapeOVALSize19mm
FlavorImprint Code44;617
Contains    
Packaging
#Item CodePackage Description
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
Part 2 of 2
MUCUS RELIEF COLD AND FLU  NIGHTTIME
acetaminophen, diphenhydramine hcl, phenylephrine hcl tablet, film coated
Product Information
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
CROSCARMELLOSE SODIUM 
FD&C BLUE NO. 1 
HYPROMELLOSE, UNSPECIFIED 
MAGNESIUM STEARATE 
MICROCRYSTALLINE CELLULOSE 
POLYDEXTROSE 
POVIDONE, UNSPECIFIED 
STEARIC ACID 
TITANIUM DIOXIDE 
TRIACETIN 
CROSPOVIDONE, UNSPECIFIED 
POLYETHYLENE GLYCOL, UNSPECIFIED 
SILICON DIOXIDE 
Product Characteristics
ColorBLUEScoreno score
ShapeOVALSize16mm
FlavorImprint Code44;544
Contains    
Packaging
#Item CodePackage Description
110 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34109/19/2006
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34104/07/2013
Labeler - Wal-Mart Stores Inc (051957769)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(49035-997)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(49035-997)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837PACK(49035-997)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(49035-997)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088PACK(49035-997)

 
Wal-Mart Stores Inc

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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