Label: DAYTIME MUCUS RELIEF SEVERE CONGESTION AND COUGH AND NIGHTTIME COLD AND FLU MAXIMUM STRENGTH- dextromethorphan hbr, guaifenesin, phenylephrine hci, acetaminophen, diphenhydramine hci kit
- NDC Code(s): 0363-0337-06, 0363-0460-06, 0363-0862-12
- Packager: Walgreens
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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 Label Information
Updated March 14, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients for Nighttime (in each 20 mL)
- Active ingredients for Daytime (in each 20 mL)
- Purpose for Nighttime
- Purpose for Daytime
-
Uses
Nighttime
- temporarily relieves these common cold and flu symptoms
- cough
- nasal congestion
- minor aches and pains
- sore throat
- headache
- runny nose
- sneezing
- temporarily reduces fever
- controls cough to help you get to sleep
Daytime
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageway of bothersome mucus and make coughs more productive
- temporarily relieves
- cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
- the intensity of coughing
- the impulse to cough to help you get to sleep
- nasal congestion due to a cold
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Warnings
NIGHTTIME
Liver warning: This product 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
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
- 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.
- for children under 12 years of age
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
- taking the blood thinning drug warfarin
- 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 occur with fever, rash, or headache that lasts. These could be signs of a serious condition.
If pregnant or breast-feeding,
Nighttime
ask a health professional before use.
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
- 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 = mililiter
- dose as follows or as directed by a doctor
- adults and children 12 years and older: 20 mL every 4 hours while symptoms last
- children under 12 years of age: do not use
Daytime
- do not take more than 6 doses in any 24-hours period
- measure only with dosing cup provided. Do not use any other dosing device.
- keep dosing cup with product
- mL = mililiter
- shake well before using
- adults and children 12 years of age and older: 20 mL in dosing cup provided every 4 hours
- children under 12 years of age: do not use
- Other information
-
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?
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Principal Display Panel
Compare to Maximum Strength Mucinex® Fast-Max® Severe Congestion & Cough & Night Time Cold & Flu active ingredient††
NIGHTTIME
Cold & Flu
ACETAMINOPHEN /
PAIN RELIEVER & FEVER REDUCER
DIPHENHYDRAMINE HCI /
ANTIHISTAMINE / COUGH SUPPRESSANT
PHENYLEPHRINE HCI /
NASAL DECONGESTANT
MAXIMUM STRENGTH
- Relieves aches, fever, sore throat, nasal congestion, runny nose, & sneezing
- Controls cough
- For ages 12 & over
DAYTIME
Severe Congestion & Cough
DEXTROMETHORPHAN HBr /
COUGH SUPPRESSANT
GUAIFENESIN / EXPECTORANT
PHENYLEPHRINE HCI / NASAL DECONGESTANT
MAXIMUM STRENGTH
- Controls Cough
- Clears nasal & chest congestion
- Thins & loosens mucus
- For ages 12 & over
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 & Nighttime Cold & Flu.
DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015
walgreens.com
- Product Label
-
INGREDIENTS AND APPEARANCE
DAYTIME MUCUS RELIEF SEVERE CONGESTION AND COUGH AND NIGHTTIME COLD AND FLU MAXIMUM STRENGTH
dextromethorphan hbr, guaifenesin, phenylephrine hci, acetaminophen, diphenhydramine hci kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0862 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-0862-12 1 in 1 KIT; Type 0: Not a Combination Product 07/31/2015 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 MUCUS RELIEF SEVERE CONGESTION AND COUGH MAXIMUM STRENGTH
dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride liquidProduct Information Item Code (Source) NDC:0363-0337 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 Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-0337-06 177 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 07/31/2015 Part 2 of 2 NIGHTTIME COLD AND FLU MAXIMUM STRENGTH
acetaminophen, diphenhydramine hci, phenylephrine hci liquidProduct Information Item Code (Source) NDC:0363-0460 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 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-0460-06 177 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 07/31/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 07/31/2015 Labeler - Walgreens (008965063)
