Label: SINUS MAX RELIEF DAY AND NIGHT- acetaminophen, dextromethorphan hydrobromide, guaifenesin, doxylamine succinate, and phenylephrine hydrochloride kit
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Contains inactivated NDC Code(s)
NDC Code(s): 36800-765-12 - Packager: TOPCO ASSOCIATES LLC
- 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 15, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
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ACTIVE INGREDIENT
Active ingredients (in each softgel) DAY Purposes Acetaminophen 325 mg Pain reliever/fever reducer Dextromethorphan HBr 10 mg Cough suppressant Guaifenesin 200 mg Expectorant Phenylephrine HCl 5 mg Nasal decongestant Active ingredients (in each softgel) NIGHT Purposes Acetaminophen 325 mg Pain reliever/fever reducer Dextromethorphan HBr 10 mg Cough suppressant Doxylamine succinate 6.25 mg Antihistamine Phenylephrine HCl 5 mg Nasal decongestant -
Uses
- temporarily relieves:
- nasal congestion
- headache
- cough
- minor aches & pains
- sinus congestion & pressure
- runny nose and sneezing (NIGHT only)
- temporarily 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 (DAY only)
- temporarily relieves:
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Warnings
Liver warning
This product contains acetaminophen. Severe liver damage may occur if you take
- more than 12 softgels in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using these products
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
- 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
- liver disease
- heart disease
- diabetes
- high blood pressure
- thyroid disease
- trouble urinating due to an enlarged prostate gland
- glaucoma (NIGHT only)
- a breathing problem such as emphysema or chronic bronchitis (NIGHT only)
- persistent or chronic cough such 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
- taking the blood thinning drug warfarin.
- taking sedatives or tranquilizers (NIGHT only)
When using these products
- do not use more than directed
- excitability may occur, especially in children (NIGHT only)
- marked drowsiness may occur (NIGHT only)
- alcohol, sedatives, and tranquilizers may increase drowsiness (NIGHT only)
- avoid alcoholic drinks (NIGHT only)
- be careful when driving a motor vehicle or operating machinery (NIGHT only)
Stop use and ask a doctor if
- 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 could be signs of a serious condition.
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Directions
- do not take more than directed (see Overdose warning)
- do not take more than 12 softgels 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
- Other information
- Inactive ingredients (DAY only)
- Inactive ingredients (NIGHT only)
- Questions or comments?
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PRINCIPAL DISPLAY PANEL - Kit Carton
NDC 36800-812-24
*Compare to the active ingredients in
Mucinex® Sinus Max® DayMAXIMUM STRENGTH**
Sinus Relief
DayPAIN RELIEVER - ACETAMINOPHEN
COUGH SUPPRESSANT-
DEXTROMETHORPHAN HBR
EXPECTORANT - GUAIFENESIN
NASAL DECONGESTANT -
PHENYLEPHRINE HCL- Relieves Sinus
Pressure, Headache
& Congestion - Controls
Cough - Thins &
Loosens Mucus
DAY TIME
FOR AGES 12+FAST
DISSOLVING
SOFTGELS!actual size
16 SOFTGELS
(Liquid Filled Capsules)*Compare to the active ingredients in
Mucinex® Sinus Max® NightMAXIMUM STRENGTH**
Sinus Relief
NightPAIN RELIEVER - ACETAMINOPHEN
COUGH SUPPRESSANT-
DEXTROMETHORPHAN HBR
ANTIHISTAMINE -
DOXYLAMINE SUCCINATE
NASAL DECONGESTANT -
PHENYLEPHRINE HCL- Relieves Nasal
Congestion, Sinus
Pressure & Pain - Controls
Cough - Relieves
Runny Nose &
Sneezing
NIGHT TIME
FOR AGES 12+FAST
DISSOLVING
SOFTGELS!actual size
8 SOFTGELS
(Liquid Filled Capsules) - Relieves Sinus
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INGREDIENTS AND APPEARANCE
SINUS MAX RELIEF DAY AND NIGHT
acetaminophen, dextromethorphan hydrobromide, guaifenesin, doxylamine succinate, and phenylephrine hydrochloride kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-765 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:36800-765-12 1 in 1 CARTON 05/01/2021 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 2 BLISTER PACK 16 Part 2 2 BLISTER PACK 8 Part 1 of 2 SINUS MAX RELIEF DAY
acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride capsule, liquid filledProduct 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 GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 200 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg Inactive Ingredients Ingredient Name Strength FD&C YELLOW NO. 6 (UNII: H77VEI93A8) GELATIN, UNSPECIFIED (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color ORANGE Score no score Shape OVAL Size 20mm Flavor Imprint Code 782 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 8 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 05/01/2021 Part 2 of 2 SINUS MAX RELIEF NIGHT
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride capsule, liquid filledProduct 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, UNSPECIFIED (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM HYDROXIDE (UNII: 55X04QC32I) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color GREEN Score no score Shape OVAL Size 20mm Flavor Imprint Code 789 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 4 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 05/01/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 05/01/2021 Labeler - TOPCO ASSOCIATES LLC (006935977)