MUCUS RELIEF ALL IN ONE DAYTIME NIGHTTIME COLD FLU MAXIMUM STRENGTH- acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl, acetaminophen, diphenhydramine hcl phenylephrine hcl kit

Mucus Relief All In One Daytime Nighttime Cold Flu by

Drug Labeling and Warnings

Mucus Relief All In One Daytime Nighttime Cold Flu by is a Otc medication manufactured, distributed, or labeled by Walgreens. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients for Day Time (in each 20 mL)

Acetaminophen 650 mg 

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Phenylephrine HCL 10 mg

Active ingredients for Night Time (in each 20 mL)

Acetaminophen 650 mg

Diphenhydramine HCL 25 mg

Phenylephrine HCL 10 mg

Purposes for Day Time

pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Purpose for Night Time

Pain reliever/fever reducer

Antihistamine/Cough suppressant

Nasal decongestant

Uses

Daytime

• temporarily relieves these common cold and flu symptoms
  • cough
  • nasal congestion 
  • minor aches and pain
  • sore throat
  • headache
  • stuffy nose
  • sinus congestion and pressure
• temporarily reduces fever
• help loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageway of bothersome mucus and make cough more productive

Nighttime

•  temporarily relieves these common cold and flu symptoms
  • cough
  • nasal congestion
  • minor aches and pains
  • sore throat
  • headache
  • sinus congestion and pressure
  • runny nose
  • sneezing
  • itching of the nose or throat
  • itchy, watery eyes due to hay fever
  • temporarily reduces fever
  • controls cough to help you get to sleep

Warnings

Liver warning : This product contains 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

• 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.
• for children under 12 years of age

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.
• with any other drug containing diphenhydramine, even one used on the skin
• if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certan 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
• heart disease
• diabetes
• thyroid disease
• high blood pressure
• trouble urinating due to an enlarged prostate gland
• persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, emphysema
• cough that occurs with too much phlegm (mucus)

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
• 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 drowsinessmay occur
• alcohol, sedative, and tranquilizers may increase drowsiness
• avoid alcohol drinks
• be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

Daytime

• 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 signs of a serious condition.

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 fever, 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.

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 adult 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 6 doses in any 24-hour period
• measure only with dosing cup provided. Do not use any other dosing device
• keep dosing cup with product
•  mL= milliliter
• dose as follows or as directed by a doctor
• adult and children 12 years of age and over: 20 mL in dosing cup provided avery 4 hours
• Children under 12 years of age do not use

Nighttime

• do not take more than directed (see overdose warning)
• do not take more than 6 doses in any 24-hour period
• measure only with dosing cup provided. Do not use any other dosing device
• keep dosing cup with product
• mL= milliliter
• dose as follows or as directed by a doctor
• adult and children 12 years and older: 20 mL every 4 hours while symptoms last
• children under 12 years of age do not use 

Other information

Daytime

• each 20 mL contains: sodium 12 mg
• store between 20º-25ºC (68º-77ºF). Do not refrigerate.

Nighttime

• each 20 mL contains: sodium 12 mg
• store betweem 20-25ºC (68-77ºF). Do not refrigerate

Inactive ingredients

Inactive ingredients for Day Time 

 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

Inactive ingredients for Night Time 

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

Principal Display Panel

DAYTIME

Cold & Flu

ACETAMINOPHEN 650 mg / PAIN RELIEVER / FEVER REDUCER

DEXTROMETHORPHAN HBr 20 mg / COUGH SUPPRESSANT

GUAIFENESIN 400 mg / EXPECTORANT

PHENYLEPHRINE HCL 10 mg / NASAL DECONGESTANT

MAXIMUM STRENGTH

• Relieves aches, fever, sore throat, nasal & chest congestion, sinus congestion & pressure
• Controls cough
• Thins & loosen mucus
• 12 years & older

FL OZ (mL)

Compare to Maximum Strength Mucinex® Fast-Max® All-In-One Cold & Flu & Night Time Cold & Flu active ingredient††

NIGHTTIME

Cold & Flu

ACETAMINOPHEN 650 mg / PAIN RELIEVER / FEVER REDUCER

DIPHENHYDRAMINE HCL 25 mg / ANTIHISTAMINE / COUGH SUPPRESSANT

PHENYLEPHRINE HCL 10 mg / NASAL DECONGESTANT

MAXIMUM STRENGTH

• Relieves cough, fever, sore throat, body pain, sneezing, itchy throat, headache, nasal congestion & runny nose
• 12 years & older

FL OZ (mL)

Questions or comments? Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

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® All-In-One Cold & Flu & Night Time Cold & Flu

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

Product Label

WALGREENS Daytime Nighttime Cold & Flu

INGREDIENTS AND APPEARANCE

MUCUS RELIEF ALL IN ONE DAYTIME NIGHTTIME COLD FLU  MAXIMUM STRENGTH
acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl, acetaminophen, diphenhydramine hcl phenylephrine hcl kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-9140

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-9140-12	1 in 1 KIT; Type 0: Not a Combination Product	09/30/2019

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE, PLASTIC	177 mL
Part 2	1 BOTTLE, PLASTIC	177 mL

Part 1 of 2

DAYTIME COLD FLU  MAXIMUM STRENGTH
acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid

Product Information
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg  in 20 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	400 mg  in 20 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg  in 20 mL
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	650 mg  in 20 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FD&C RED NO. 40 (UNII: WZB9127XOA)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYL GALLATE (UNII: 8D4SNN7V92)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	09/30/2019

Part 2 of 2

NIGHTTIME COLD AND FLU  MAXIMUM STRENGTH
acetaminophen, diphenhydramine hcl, phenylephrine hcl liquid

Product Information
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	650 mg  in 20 mL
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg  in 20 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg  in 20 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
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 Code	Package Description	Marketing Start Date	Marketing End Date
1		177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	09/30/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	09/30/2019

Labeler - Walgreens (008965063)