MUCUS RELIEF SEVERE CONGESTION COUGH NIGHT TIME COLD AND FLU MAXIMUM STRENGTH- dextromethorphan hbr, guaifenesin, phenylephrine hci, acetaminophen, diphenhydramine hci, phenylephrine hci 
Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)

----------

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)

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

Cough suppressant

Expectorant

Nasal decongestant

Uses

Nighttime

Daytime

Warnings

NIGHTTIME

 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

  • 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

  • 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

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
  • symptoms do not get better within 7 days or occur with fever 
  • 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

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.

DayTime

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

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

Questions or comments?

Nighttime and DayTime

Call 1-888-309-9030

Principal Display Panel

Compare to the active ingredients of Maximum Strength Mucinex® Fast-Max® Severe Congestion & Cough & Night Time Cold & Flu*

NIGHTTIME

Maximum Strength

Fast Acting Night Time Cold & Flu

Multi-Symptom Relief

Acetaminophen

DiphenhydramineHCI

Phenylephrine HCI

Pain Reliever/Fever reducer

Antihistamine/Cough Suppressant

Nasal Decongestant

DAYTIME

Maximum Strength

Fast Acting

Mucus Relief

Severe Congestion & Cough

Multi-Symptom Relief

Dextromethorphan HBr

Guaifenesin

Phenylephrine HCI

Cough Suppressant

Expectorant

Nasal Decongestant

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

↑↑This product is not manufactured or distributed by Reckitt Benckiser, distributor of Maximum Strength Mucinex® FAST-MAX® Severe Congestion & Cough and Nighttime Cold & Flu.

DISTRIBUTED BY OLD EAST MAIN CO.

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072

Product Label

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

DOLLAR GENERAL HEALTH Maximum Strength Mucus Relief Severe Congestion and Cough, Cold Flu

MUCUS RELIEF SEVERE CONGESTION COUGH NIGHT TIME COLD AND FLU  MAXIMUM STRENGTH
dextromethorphan hbr, guaifenesin, phenylephrine hci, acetaminophen, diphenhydramine hci, phenylephrine hci kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-562
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55910-562-121 in 1 KIT; Type 0: Not a Combination Product03/31/2018
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE, PLASTIC 177 mL
Part 21 BOTTLE, PLASTIC 177 mL
Part 1 of 2
MUCUS RELIEF CONGESTION COUGH  MAXIMUM STRENGTH SEVERE CONGESTION AND COUGH
dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride liquid
Product Information
Item Code (Source)NDC:55910-537
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
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 DrugM01203/31/2018
Part 2 of 2
NIGHTTIME COLD AND FLU  MAXIMUM STRENGTH
acetaminophen, diphenhydramine hci, phenylephrine hci liquid
Product Information
Item Code (Source)NDC:55910-460
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 DrugM01203/31/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01203/31/2018
Labeler - Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) (068331990)

Revised: 10/2023
Document Id: 2ef0bda0-f49e-4e10-84d5-ec4a368003fb
Set id: 0d65c4a9-938c-4a89-b1f1-d9ada8a8c587
Version: 7
Effective Time: 20231010
 
Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)