DAYTIME SINUS RELIEF AND NIGHTTIME SINUS RELIEF- acetaminophen, doxylamine succinate, phenylephrine hydrochloride kit

Daytime Sinus Relief and Nighttime Sinus Relief by

Drug Labeling and Warnings

Daytime Sinus Relief and Nighttime Sinus Relief by is a Otc medication manufactured, distributed, or labeled by Chain Drug Marketing Association Inc., Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients for Nighttime Sinus (in each softgel)

Acetaminophen 325 mg

Doxylamine succinate 6.25 mg

Phenylephrine HCl 5 mg

Active ingredients for Daytime Sinus (in each softgel)

Acetaminophen 325 mg
Phenylephrine hydrochloride 5 mg

Purposes

Nighttime Sinus Relief

Pain reliever/Fever reducer

Antihistamine

Nasal decongestant

Purposes

Daytime Sinus Relief

Pain reliever/Fever reducer

Nasal decongestant

Uses

• temporarily relieves symptoms due to the common cold
  • minor aches and pains
  • headache
  • fever
  • runny nose and sneezing (Nighttime only)
  • nasal congestion
  • sinus congestion & pressure
• temporarily relieves symptoms due to hay fever or other upper respiratory allergies
  • minor aches and pains
  • headache
  • runny nose and sneezing (Nighttime only)
  • itching of the nose or throat, and itchy, watery eyes (Nighttime only)
  • nasal congestion
  • sinus congestion & pressure

Warnings

Liver warning

These products contain acetaminophen. Severe liver damage may occur if you take

• more than 10 softgels in 24 hours, which is the maximum daily amount for this product
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product

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. 
• to make a child sleep (Nighttime only)    

Ask a doctor before use if you have

• liver disease      
• heart disease              
• thyroid disease
• diabetes  
• high blood pressure  
• glaucoma (Nighttime only)             
• a breathing problem such as emphysema or chronic bronchitis (Nighttime only)  
• trouble urinating due to enlarged prostate gland

Ask a doctor or pharmacist before use if you are

• taking sedatives or tranquilizers (Nighttime only)             
• taking the blood thinning drug warfarin

When using this product

• do not use more than directed, in addition when using Nighttime Sinus and Congestion:
• excitability may occur, especially in children
• marked drowsiness may occur
• avoid alcoholic drinks
• be careful when driving a motor vehicle or operating machinery
• alcohol, sedatives & tranquilizers may increase drowsiness

Stop use and ask a doctor if

• pain or nasal congestion gets worse or last more than 7 days            
• fever gets worse or lasts more than 3 days
• redness or swelling is present 
• new symptoms occur
• you get nervous, dizzy or sleepless  

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

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms.

Directions

• take only as directed
• do not exceed 4 doses per 24 hours

Age	Daytime Sinus	Nighttime Sinus
adults and children 12 years and over	2 softgels with water every 4 hours	2 softgels with water every 4 hours
children 4 to under 12 years	ask a doctor	ask a doctor
children under 4 years	do not use	do not use

Other information

• store at room temperature 15°-30°C (59°-86°F) and avoid excessive heat

Inactive ingredients

Nighttime Sinus: FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special, white edible ink

Daytime Sinus: FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special, white edible ink

Questions or comments?

Call 248-449-9300

Principal Display Panel

CDMA Daytime Sinus Relief and Nighttime Sinus Relief 48 SOFTGELS

NDC: 63868-464-48

Compare to the active ingredients in Vicks® QlearQuilTM Daytime Sinus & Congestion and Nighttime Sinus & Congestion*

INGREDIENTS AND APPEARANCE

DAYTIME SINUS RELIEF AND NIGHTTIME SINUS RELIEF 
acetaminophen, doxylamine succinate, phenylephrine hydrochloride kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63868-464

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63868-464-48	1 in 1 CARTON; Type 0: Not a Combination Product	04/12/2017

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	4 BLISTER PACK	32
Part 2	2 BLISTER PACK	16

Part 1 of 2

DAYTIME SINUS RELIEF 
acetaminophen, 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
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
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)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	orange (clear)	Score	no score
Shape	capsule (oblong)	Size	20mm
Flavor		Imprint Code	PC12
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		4 in 1 CARTON
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	04/12/2017

Part 2 of 2

NIGHTTIME SINUS RELIEF 
acetaminophen, doxylamine succinate, 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
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	6.25 mg

Inactive Ingredients
Ingredient Name	Strength
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)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	blue (clear)	Score	no score
Shape	capsule (oblong)	Size	20mm
Flavor		Imprint Code	PC13
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		2 in 1 CARTON
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	04/12/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	04/12/2017

Labeler - Chain Drug Marketing Association Inc. (011920774)

Establishment
Name	Address	ID/FEI	Business Operations
Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd		421293287	manufacture(63868-464) , analysis(63868-464)