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Severe Congestion and Cough, Cold and Flu Daytime, Nighttime

Dosage form: kit
Ingredients: DEXTROMETHORPHAN HYDROBROMIDE 10mg, GUAIFENESIN 200mg, PHENYLEPHRINE HYDROCHLORIDE 5mg; ACETAMINOPHEN 325mg, DIPHENHYDRAMINE HYDROCHLORIDE 12.5mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: CVS Pharmacy
NDC Code: 69842-987

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.

CVS 44-648694

Active ingredients (in each caplet)
(Daytime Severe Congestion & Cough)

Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg

Purpose

Cough suppressant
Expectorant
Nasal decongestant

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

Acetaminophen 325 mg
Diphenhydramine HCl 12.5 mg
Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer
Antihistamine/cough suppressant
Nasal decongestant

Uses (Daytime only)
  • temporarily relieves:
  • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
  • nasal congestion due to a cold
  • the intensity of coughing
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Uses (Nighttime only)
  • temporarily relieves these common cold and flu symptoms:
  • headache
  • sore throat
  • nasal congestion
  • runny nose and sneezing
  • cough
  • minor aches and pains
  • temporarily reduces fever
  • controls cough to help you get to sleep

Warnings
(Nighttime only)

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

  • with other drugs containing acetaminophen
  • more than 4,000 mg of acetaminophen in 24 hours
  • 3 or more alcoholic drinks every day while using this product

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

  • blisters
  • rash
  • skin reddening

If a skin reaction occurs, stop use and seek medical help right away.

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
  • 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.
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. (Nighttime only)
  • if you have ever had an allergic reaction to this product or any of its ingredients (Nighttime only)
  • with any other product containing diphenhydramine, even one used on skin (Nighttime only)

Ask a doctor before use if you have
  • heart disease
  • diabetes
  • thyroid disease
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • high blood pressure
  • difficulty in urination due to enlargement of the prostate gland
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem such as emphysema or chronic bronchitis (Nighttime only)
  • glaucoma (Nighttime only)
  • liver disease (Nighttime only)

Ask a doctor or pharmacist before use if you are (Nighttime only)

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

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

Stop use and ask a doctor if
  • nervousness, dizziness, or sleeplessness occur
  • symptoms do not get better within 7 days or occur with fever (Daytime only)
  • redness or swelling is present (Nighttime only)
  • pain, nasal congestion, or cough gets worse or lasts more than 7 days (Nighttime only)
  • new symptoms occur (Nighttime only)
  • fever gets worse or lasts more than 3 days (Nighttime only)
  • cough comes back or occurs with rash or headache that lasts.

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 accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

If taking NIGHTTIME and DAYTIME products, carefully read each section to ensure correct dosing. Do not take DAY & NIGHT at the same time.

Directions
  • do not use more than directed
  • do not take more than 12 caplets in any 24-hour period
  • adults and children 12 years and over: take 2 caplets every 4 hours
  • children under 12 years: do not use

Other information
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • see end flap for expiration date and lot number

Inactive ingredients (Daytime only)

corn starch, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polysorbate 80, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide

Inactive ingredients (Nighttime only)

corn starch, croscarmellose sodium, crospovidone, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, iron oxide yellow, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium bicarbonate, stearic acid, talc, titanium dioxide

Questions or comments?

1-800-426-9391

Principal Display Panel

♥︎CVS
Health

Compare to the active ingredients in
Maximum Strength Mucinex® FAST-MAX®
DAY TIME Severe Congestion & Cough
& NIGHT TIME Cold & Flu*

NDC 69842-987-01       

MAXIMUM STRENGTH Daytime
Severe Congestion
& Cough

DEXTROMETHORPHAN HBr - Cough suppressant
GUAIFENESIN - Expectorant
PHENYLEPHRINE HCl - Nasal decongestant

Multi-Symptom:
• Controls cough
• Relieves nasal & chest congestion
• Thins & loosens mucus

20 CAPLETS

Actual Size

MAXIMUM STRENGTH Nighttime
Cold & Flu

ACETAMINOPHEN - Pain reliever, Fever reducer
DIPHENHYDRAMINE HCl - Antihistamine
PHENYLEPHRINE HCl - Nasal decongestant

Relieves:
• Aches, fever & sore throat
• Cough
• Runny nose & sneezing
• Nasal congestion

10 CAPLETS

Actual Size

             C-0231-648694-01IH
50844     ORG051764869401

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® DAY TIME Severe Congestion & Cough and NIGHT TIME Cold & Flu.
50844                  ORG051764869401

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2017 CVS/pharmacy
CVS.com® 1-800-SHOP CVS

V-19849

✓CVS® Quality
Money Back Guarantee

CVS 44-648694

SEVERE CONGESTION AND COUGH, COLD AND FLU  DAYTIME, NIGHTTIME
acetaminophen, dextromethorphan hbr, diphenhydramine hcl, guaifenesin, phenylephrine hcl kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-987
Packaging
#Item CodePackage Description
1NDC:69842-987-011 KIT in 1 PACKAGE, COMBINATION
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 12 BLISTER PACK 20 
Part 21 BLISTER PACK 10 
Part 1 of 2
SEVERE CONGESTION AND COUGH  DAYTIME
dextromethorphan hbr, guaifenesin, phenylephrine hcl tablet, film coated
Product Information
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE10 mg
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN200 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
FD&C BLUE NO. 2 
FD&C RED NO. 40 
MAGNESIUM STEARATE 
MALTODEXTRIN 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
POLYSORBATE 80 
POVIDONE 
SILICON DIOXIDE 
STEARIC ACID 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorRED (maroon) Scoreno score
ShapeOVALSize19mm
FlavorImprint Code44;648
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 FINALpart34107/20/2015
Part 2 of 2
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 HYDROCHLORIDE12.5 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
CROSCARMELLOSE SODIUM 
CROSPOVIDONE 
FD&C BLUE NO. 1 
FD&C BLUE NO. 2 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
POVIDONE 
SILICON DIOXIDE 
STEARIC ACID 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorBLUEScoreno score
ShapeOVALSize19mm
FlavorImprint Code44;694
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 FINALpart34107/01/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34107/01/2017
Labeler - CVS Pharmacy (062312574)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(69842-987)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837PACK(69842-987)

Revised: 08/2017
 
CVS Pharmacy

← See all Severe Congestion and Cough, Cold and Flu Daytime, Nighttime brands

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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