Label: DAYTIME NIGHTTIME SINUS RELIEF MAXIMUM STRENGTH- acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl,guaifenesin kit
- NDC Code(s): 69842-822-24
- Packager: CVS Pharmacy
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 20, 2023
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active ingredients in Daytime (in each softgel)
- Active ingredients in Nighttime (in each softgel)
- Purpose for Daytime
- Purpose for Nighttime
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Uses
DAYTIME
- temporarily relieves
- nasal congestion
- headache
- cough due to inhaled irritants
- sinus congestion and pressure
- minor aches and pains
- promotes nasal and/or sinus drainage
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
NIGHTTIME
- temporarily relieves
- nasal congestion
- cough due to inhaled irritants
- headache
- sinus congestion and pressure
- minor aches and pains
- runny nose and sneezing
- promotes nasal and/or sinus drainage
- temporarily relieves
-
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
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
- high blood pressure
- diabetes
- 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
- high blood pressure
- diabetes
- heart disease
- thyroid disease
- glaucoma
- 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 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 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 the active ingredients in Maximum Strength Mucinex® Sinus-Max® Day and Maximum Strength Mucinex® Sinus-Max® Night†
DAYTIME
MAXIMUM STRENGTH
Daytime
Sinus Relief
ACETAMINOPHEN - 325 mg Pain reliever
DEXTROMETHORPHAN - 10 mg Cough Suppressant
GUAIFENESIN - 200 mg Expectorant
PHENYLEPHRINE HCI - 5 mg Nasal Decongestant
- Relieves sinus pressure, headache & congestion
- Controls cough
- thins & loosens mucus
SOFTGELS
NIGHTTIME
MAXIMUM STRENGTH
Nighttime
Sinus Relief
ACETAMINOPHEN - 325 mg Pain reliever
DEXTROMETHORPHAN HBr - 10 mg Cough Suppressant
DOXYLAMINE SUCCINATE - 6.25 mg Antihistamine
PHENYLEPHRINE HCI - 5 mg Nasal Decongestant
- Relieves nasal congestion, sinus pressure & pain
- Controls cough
- Controls runny nose and sneezing
For ages
12 Years & Older
Alcohol Free
SOFTGELS**
(**Liqui-Filled Capsules)
*This product is not manufactured or distributed by Reckitt Benckiser, distributor of Maximum Strength Mucinex® Sinus-Max® Day and Maximum Strength Mucinex® Sinus-Max® Night.
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: CVS Pharmacy, Inc,
One CVS Drive, Woonsocket, RI 02896
CVS.com® 1800-SHOP CVS
- Product Label
-
INGREDIENTS AND APPEARANCE
DAYTIME NIGHTTIME SINUS RELIEF MAXIMUM STRENGTH
acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl,guaifenesin kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69842-822 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69842-822-24 1 in 1 KIT; Type 0: Not a Combination Product 01/31/2019 12/31/2024 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 SINUS RELIEF 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 Drug M012 01/31/2019 12/31/2024 Part 2 of 2 DAYTIME SINUS RELIEF 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 Drug M012 01/31/2019 12/31/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 01/31/2019 12/31/2024 Labeler - CVS Pharmacy (062312574)
