Label: DAYTIME MUCUS RELIEF SEVERE COLD NIGHTTIME COLD AND FLU MAXIMUM STRENGTH- acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl,guaifenesin kit
- NDC Code(s): 0363-0820-24
- 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 November 30, 2022
If you are a consumer or patient please visit this version.
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- Active ingredients in Daytime (in each softgel)
- Active ingredients in Nighttime (in each softgel)
- Purpose for Daytime
- Purpose for Nighttime
-
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
- temporarily relieves these common cold and flu symptoms
-
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
- 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.
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
-
Inactive ingredients
DAYTIME
FD&C red #40, FD&C yellow #6, gelatin, glycerin, mannitol*, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol, titanium dioxide
*may contain this ingredient
NIGHTTIME
D&C yellow #10, FD&C blue #1, gelatin, glycerin, mannitol*, polyethylene glycol, povidone, propylene glycol, purified water, shellac*, sodium hydroxide, sorbitan*, sorbitol, titanium dioxide
*contains one or more of these ingredients
- Questions or comments?
-
Principal Display Panel
Compare to Maximum Strength Mucinex® Fast-Max® Day Severe Cold & Maximum Strength Mucinex® Fast-Max® Night Cold & Flu active ingredients††
DAYTIME
Severe Cold
ACETAMINOPHEN / PAIN RELIEVER / FEVER REDUCER
DEXTROMETHORPHAN HBr / COUGH SUPPRESSANT
GUAIFENESIN / EXPECTORANT
PHENYLEPHRINE HCI / NASAL DECONGESTANT
MAXIMUM STRENGTH
ALCOHOL FREE
- Relieves aches, fever & sore throat
- Controls cough
- Thins & loosens mucus
- Clears nasal & chest congestion
- Ages 12 & over
SOFTGELS*
(*LIQUID-FILLED CAPSULES)
NIGHTTIME
Cold & Flu
ACETAMINOPHEN / PAIN RELIEVER / FEVER REDUCER
DEXTROMETHORPHAN HBr / COUGH SUPPRESSANT
DOXYLAMINE SUCCINATE / ANTIHISTAMINE
PHENYLEPHRINE HCI / NASAL DECONGESTANT
MAXIMUM STRENGTH
ALCOHOL FREE
- Relieves aches, fever & sore throat, nasal congestion, runny nose & sneezing
- Controls cough
- Ages 12 years & over
SOFTGELS*
(*LIQUID-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 BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015
walgreens.com
- Product Label
-
INGREDIENTS AND APPEARANCE
DAYTIME MUCUS RELIEF SEVERE COLD NIGHTTIME COLD AND FLU MAXIMUM STRENGTH
acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl,guaifenesin kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0820 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-0820-24 1 in 1 KIT; Type 0: Not a Combination Product 09/30/2018 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 8 BLISTER PACK 8 Part 2 16 BLISTER PACK 16 Part 1 of 2 NIGHTTIME COLD AND FLU MAXIMUM STRENGTH
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hci capsuleProduct Information Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 6.25 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg Inactive Ingredients Ingredient Name Strength 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) MANNITOL (UNII: 3OWL53L36A) Product Characteristics Color green Score no score Shape CAPSULE Size 20mm Flavor Imprint Code 116;42A Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 8 in 1 CARTON 1 1 in 1 BLISTER PACK; 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 09/30/2018 Part 2 of 2 DAYTIME MUCUS RELIEF SEVERE COLD MAXIMUM STRENGTH
acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hci capsuleProduct Information Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 200 mg Inactive Ingredients Ingredient Name Strength 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) MANNITOL (UNII: 3OWL53L36A) Product Characteristics Color orange Score no score Shape CAPSULE Size 20mm Flavor Imprint Code 341;12A Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 16 in 1 CARTON 1 1 in 1 BLISTER PACK; 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 09/30/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 09/30/2018 Labeler - Walgreens (008965063)
