DAYTIME MUCUS RELIEF SEVERE COLD AND NIGHTTIME COLD AND FLU MAXIMUM STRENGTH- acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl,guaifenesin 
CVS Pharmacy

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.

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Drug Facts

Active ingredients in Daytime (in each softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Active ingredients in Nighttime (in each softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Doxylamine succinate 6.25 mg

Phenylephrine HCI 5 mg

Purpose for Daytime

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Purpose for Nighttime

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant

Uses

DAYTIME

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

NIGHTTIME

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

Warnings

DAYTIME and NIGHTTIME

Liver warning: These products contain acetaminophen. Severe liver damage may occur if you take:

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

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

  • skin reddening
  • blisters
  • rash

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

DAYTIME and NIGHTTIME

  • 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.

Ask a doctor before use if you have

DAYTIME

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

NIGHTTIME

  • liver disease
  • diabetes
  • high blood pressure
  • heart disease
  • glaucoma
  • thyroid disease
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem or chronic cough that lasts or 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

DAYTIME

taking the blood thinning drug warfarin

NIGHTTIME

taking the blood thinning drug warfarin

taking sedatives or tranquilizers

When using this product,

DAYTIME

do not use more than directed

NIGHTTIME

  • do not use more than directed
  • excitability may occur, especially in children
  • marked drowsiness may occur 
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

DAYTIME and NIGHTTIME

  • 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
  • cough comes back or occurs with rash or headache that lasts. These coukld be signs of a serious condition.

If pregnant or breast-feeding,

DAYTIME and NIGHTTIME

ask a health professional before use.

Keep out of reach of children.

DAYTIME and NIGHTTIME

Overdose warning: Taking more than the recommended dose can 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

DAYTIME

  • do not take more than directed (see Overdose warning)
  • do not take more than 12 softgels (Daytime and NightTime) in any 24-hour period
  • adults and children 12 years of age and older: take 2 softgels every 4 hours
  • children under 12 years of age: do not use
  • when using other Daytime or Nighttime products, carefully read each label to ensure correct dosing

NIGHTTIME

  • do not take more than directed (see Overdose warning)
  • do not take more than 12 softgels (Daytime and Nighttime) in any 24-hour period
  • adults and children 12 years of age and older: take 2 softgels every 4 hours
  • children under 12 years of age: do not use
  • when using other Daytime or Nighttime products, carefully read each label to ensure correct dosing 

Other information

DAYTIME and NIGHTTIME

  • swallow whole; do not crush, chew, or dissolve
  • store between 15-30ºC (59-86F)
  • avoid excessive heat

Inactive ingredients

DAYTIME

FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol, titanium dioxide

NIGHTTIME

D&C yellow #10, FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sodium hydroxide, sorbitan*, sorbitol, titanium dioxide

Questions or comments?

DAYTIME and NIGHTTIME

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

DAY & NIGHT TWIN PACK

Compare to the active ingredients in Maximum Strength Mucinex® FAST-MAX® Day Severe Cold and Maximum Strength Mucinex® FAST-MAX® Night Cold & Flu®

DAYTIME

MAXIMUM STRENGTH

Daytime Severe Cold

ACETAMINOPHEN - 325 mg Pain Reliever ; Fever Reducer

DEXTROMATHORPHAN HBr - 10 mg  Cough Suppressant

GUAIFENESIN - 200 mg  Expectorant

PHENYLEPHRINE HCI - Nasal Decongestant

  • Relieves aches, fever & sore throat
  • Controls cough
  • Relieves nasal & chest congestion
  • thins & loosens mucus

LIQUID GELS

NIGHTTIME

MAXIMUM STRENGTH

Nighttime Cold & Flu

ACETAMINOPHEN - 325 mg Pain Reliever ; Fever Reducer

DEXTROMETHORPHAN HBr - 10 mg Cough Suppressant

DOXYLAMINE SUCCINATE - 6.25 mg Antihistamine

PHENYLEPHRINE HCI - 5 mg Nasal Decongestant

  • Relieves aches, fever & sore throat
  • Controls cough
  • Relieves nasal congestion
  • Relieves runny nose & sneezing

LIQUID GELS

(*Liqui-Filled Capsules)

*This product is not manufactured or distributed by Reckitt Benckiser, distributor of Maximum Strength Mucinex® FAST-MAX® Day Severe Cold and Maximum Strength Mucinex® FAST-MAX® Night Cold & Flu.

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

CVS.com® 1-800-SHOP CVS

Product Label

DAYTIME Acetaminophen 325 mg, Dextromethorphan HBr 10 mg, Guaifenesin 200 mg, Phenylephrine HCI 5 mg NIGHTTIME Acetaminophen 325 mg, Dextromethorphan HBr 10mg, Doxylamine Succinate 6.25 mg, Phenylephrine HCI 5 mg

CVS DayTime Maximum Strength Severe Cold and Maximum Strength NightTime Cold & Flu

DAYTIME MUCUS RELIEF SEVERE COLD AND NIGHTTIME COLD AND FLU  MAXIMUM STRENGTH
acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl,guaifenesin kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-564
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-564-241 in 1 CARTON; Type 0: Not a Combination Product05/31/201602/01/2023
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 18 BLISTER PACK
Part 216 BLISTER PACK 16 
Part 1 of 2
NIGHTTIME COLD AND FLU  MAXIMUM STRENGTH
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hci capsule
Product Information
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SORBITAN (UNII: 6O92ICV9RU)  
SORBITOL (UNII: 506T60A25R)  
SHELLAC (UNII: 46N107B71O)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorgreenScoreno score
ShapeCAPSULESize20mm
FlavorImprint Code 116
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
18 in 1 CARTON
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/31/201602/01/2022
Part 2 of 2
SEVERE COLD  MAXIMUM STRENGTH DAYTIME
acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hci capsule
Product Information
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SORBITAN (UNII: 6O92ICV9RU)  
SORBITOL (UNII: 506T60A25R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColororangeScoreno score
ShapeCAPSULESize20mm
FlavorImprint Code 341
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
116 in 1 CARTON
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/31/201602/01/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/31/201602/01/2023
Labeler - CVS Pharmacy (062312574)

Revised: 10/2021
 
CVS Pharmacy