DAYTIME MUCUS RELIEF SEVERE COLD AND NIGHTTIME COLD AND FLU MAXIMUM STRENGTH- daytime acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hci, nighttime acetaminophen, diphenhydramine hci, phenylephrine hci 
TARGET Corporation

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.

----------

DRUG FACTS

Active ingredients for Nighttime (in each 20 mL)

Acetaminophen 650 mg

Diphenhydramine HCI 25 mg

Phenylephrine HCI 10 mg 

Active ingredients for Daytime (in each 20 mL)

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Guaifeenesin 400 mg

Phenylephrine HCl 10 mg

Purpose for Nighttime

Pain reliever/fever reducer

Antihistamine/cough suppressant

Nasal decongestant

Purpose for Daytime

Pain reliever / fever reducer 

Cough suppressant

Expectorant

Nasal decongestant

Uses

Nighttime

Daytime

Warnings

NIGHTTIME and DAYTIME

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

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

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

Nighttime

  • with any drug containing acetaminophen (prescription or nonprescription) . If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • with any other drug containing diphenhydramine, even one used on the skin
  • 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
  • for children under 12 years of age

Daytime

  • with any other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • for children under 12 years of age
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI)(certain drugs for depression,psychiatic 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

Nighttime

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

Daytime

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

Ask a doctor or pharmacist before use if you are

Nighttime

  • you are taking the blood thinning drug warfarin
  • you are taking sedative or tranquilizers

Daytime

  • taking the blood thinning drug warfarin

When using these products

Nighttime

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

Daytime

  • do not use more than directed

Stop use and ask a doctor if

Nighttime

  • nervousness, dizziness, or sleeplessness occur
  • pain, nasal congestion, or cough gets worse, or lasts more than 7 days
  • fever gets worse, or last more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • cough comes back or occurs with rash or headache that lasts. These could be a signs of a serious condition

 Daytime

  • 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 could be signs of a serious condition. 

If pregnant or breast-feeding,

Nighttime and DayTime

ask a health professional before use.

Keep out of reach of children.

Nighttime and DayTime

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

Nighttime

Daytime


Other information

Nighttime

Daytime

Inactive ingredients

Nighttime

citric acid, disodium EDTA, FD&C Blue #1, FD&C red #40, Flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum

Daytime

citric acid, disodium EDTA, FD&C blue #1, FD&C red #40, flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum

Principal Display Panel

NIGHTTIME

Compare to active ingredients in Maximum Strength Mucinex®Fast-Max® Night Time Cold & Flu**

maximum strength

nighttime

Cold & Flu

acetaminophen (pain reliever / fever reducer)

diphenhydramine HCI (antihistamine / cough suppressant)

phenylephrine HCI (nasal decongestant)

Relieves aches, fever, sore throat

controls cough

relieves nasal congestion

relieves runny nose and sneezing  

AGES 12 + YEARS

DAYTIME

Compare to active ingredients in Maximum Strength Mucinex® Fast-Max® Day Time Severe Cold*

maximum strength

daytime

Severe Cold

acetaminophen (pain reliever / fever reducer)

dextromethorphan HBr (cough suppressant)

guaifenesin (expectorant)

phenylephrine HCI (nasal decongestant)

Relieves aches, fever & sore throat

Controls Cough

relieves nasal and chest congestion 

thins and loosens mucus 

AGES 12 + YEARS

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND OR UNDER CAP IS BROKEN OR MISSING.

*This prodect is not manufactured or distributed by Recitt Benckiser, distributor of Maximum Strength Mucinex® Fast-Max® Day Time Severe Cold.

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

Dist. by Target Corp.

Minneapolis, MN 55403

Product of U.S.A.

©2016 Target Brands, Inc.

Questions? Call 1-800-910-6874

Product Label

Acetaminophen 650 mg, Diphenhydramine HCI 25 mg, Phenylephrine HCI 10 mg Acetaminophen 650 mg, Dextromethorphan HBr 20 mg Guaifenesin 400 mg Phenylephrine HCI 10 mg

TARGET Maximum Strength Nighttime cold and flu Maximum Strength Daytime Severe Cold

DAYTIME MUCUS RELIEF SEVERE COLD AND NIGHTTIME COLD AND FLU  MAXIMUM STRENGTH
daytime acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hci, nighttime acetaminophen, diphenhydramine hci, phenylephrine hci kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11673-463
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11673-463-121 in 1 KIT; Type 0: Not a Combination Product01/11/2018
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE, PLASTIC 177 mL
Part 21 BOTTLE, PLASTIC 177 mL
Part 1 of 2
DAYTIME MUCUS RELIEF SEVERE COLD  MAXIMUM STRENGTH
acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hci liquid
Product Information
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 20 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg  in 20 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 20 mL
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg  in 20 mL
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
EDETATE CALCIUM DISODIUM (UNII: 25IH6R4SGF)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYL GALLATE (UNII: 8D4SNN7V92)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart341
Part 2 of 2
NIGHTTIME COLD AND FLU  MAXIMUM STRENGTH
acetaminophen, diphenhydraminehci, phenylephrine hci liquid
Product Information
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg  in 20 mL
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg  in 20 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 20 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
PROPYL GALLATE (UNII: 8D4SNN7V92)  
XANTHAN GUM (UNII: TTV12P4NEE)  
EDETATE CALCIUM DISODIUM (UNII: 25IH6R4SGF)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/11/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/11/2018
Labeler - TARGET Corporation (006961700)

Revised: 11/2022
Document Id: 73cd6cb6-e960-4ba4-b2b0-2cf6224a1e6e
Set id: 9d757c27-88b9-4e31-b9ec-fa6bb6d4969b
Version: 3
Effective Time: 20221118
 
TARGET Corporation