Label: DAYTIME NIGHTTIME SINUS RELIEF MAXIMUM STRENGTH- acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl,guaifenesin kit
- NDC Code(s): 0363-0723-24
- Packager: Walgreens
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 10, 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
- 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, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol, titanium dioxide
NIGHTTIME
D&C yellow #10, FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sodium hydroxide, sorbitan*, sorbitol, titanium dioxide
- Questions or comments?
-
Principal Display Panel
DAYTIME
Sinus Relief
Acetaminophen / Pain Reliever
Dextromethorphan HBr / Cough Suppressant
Guaifenesin / Expectorant
Phenylephrine HCI / Nasal Decongestant
MAXIMUM STRENGTH
ALCOHOL FREE
- Relieves sinus pressure, headache & congestion
- Controls cough
- thins & loosens mucus
- For ages 12 years & over
SOFTGELS*
NIGHTTIME
Sinus Relief
Acetaminophen / Pain Reliever
Dextromethorphan HBr/ Cough Suppressant
Doxylamine Succinate / Antihistamine
Phenylephrine HCI / Nasal Decongestant
MAXIMUM STRENGTH
ALCOHOL FREE
- Relieves nasal congestion, sinus pressure & pain, runny nose & sneezing
- Controls cough
- For ages 12 years & over
SOFTGELS*
(*LIQUID-FILLED CAPSULES)
Compare to Maximum Strength Mucinex® Sinus-Max® Day & Mucinex® Sinus-Max® Night active ingredients≠≠
≠≠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 CARTON IS OPENED OR 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 NIGHTTIME SINUS RELIEF MAXIMUM STRENGTH
acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl,guaifenesin kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0723 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-0723-24 1 in 1 CARTON; Type 0: Not a Combination Product 05/31/2016 02/28/2025 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) Product Characteristics Color green Score no score Shape CAPSULE Size 20mm Flavor Imprint Code 116 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 05/31/2016 02/28/2025 Part 2 of 2 DAYTIME SINUS RELIEF
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) Product Characteristics Color orange Score no score Shape CAPSULE Size 20mm Flavor Imprint Code 341 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 05/31/2016 02/28/2025 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 05/31/2016 02/28/2025 Labeler - Walgreens (008965063)
