SINUS MAX RELIEF DAY AND NIGHT- acetaminophen, dextromethorphan hydrobromide, guaifenesin, doxylamine succinate, and phenylephrine hydrochloride kit

Sinus Max Relief Day and Night by

Drug Labeling and Warnings

Sinus Max Relief Day and Night by is a Otc medication manufactured, distributed, or labeled by TOPCO ASSOCIATES LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

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)

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.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

Overdose warning

In case of overdose, get medical help or contact a Poison Control Center right away.

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

• store at 20-25°C (68-77°F)
• protect from light, heat and moisture

Inactive ingredients (DAY only)

FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone K30, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide

Inactive ingredients (NIGHT only)

D&C yellow #10, FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone K30, propylene glycol, purified water, sodium hydroxide, sorbitol sorbitan solution, titanium dioxide

Questions or comments?

1-888-423-0139

PRINCIPAL DISPLAY PANEL - Kit Carton

NDC: 36800-812-24

*Compare to the active ingredients in
Mucinex® Sinus Max® Day

MAXIMUM STRENGTH**

Sinus Relief
Day

PAIN 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® Night

MAXIMUM STRENGTH**

Sinus Relief
Night

PAIN 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)

INGREDIENTS AND APPEARANCE

SINUS MAX RELIEF DAY AND NIGHT 
acetaminophen, dextromethorphan hydrobromide, guaifenesin, doxylamine succinate, and phenylephrine hydrochloride kit

Product 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 filled

Product 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 filled

Product 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)