daytime nitetime sinus

Dosage form: kit
Ingredients: ACETAMINOPHEN 325mg, DOXYLAMINE SUCCINATE 6.25mg, PHENYLEPHRINE HYDROCHLORIDE 5mg; ACETAMINOPHEN 325mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: Meijer Distribution Inc
NDC Code: 41250-515

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.

Meijer Distribution, Inc. DayTime and NiteTime Sinus Drug Facts

Active ingredient for Nighttime Sinus (in each softgel)

Acetaminophen 325 mg

Doxylamine succinate 6.25 mg

Phenylephrine HCl 5 mg

Active ingredient for Daytime Sinus (in each softgel)

Acetaminophen 325 mg

Phenylephrine HCl 5 mg

Purpose (for Nighttime Sinus)

Pain reliever

Antihistamine

Nasal decongestant

Purpose (for Daytime Sinus)

Pain reliever

Nasal decongestant

Uses

temporarily relieves nasal and sinus symptoms:

  • sinus pain
  • headache
  • nasal and sinus congestion
  • runny nose and sneezing (Nighttime Sinus only)

Warnings

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

  • more than 12 softgels in 24 hours (Nighttime) or more than 12 softgels in 24 hours (Daytime), which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using these products

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 sleepy

Ask a doctor before use if you have
  • liver disease
  • heart disease
  • thyroid disease
  • diabetes
  • high blood pressure
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis (Nighttime Sinus only)
  • glaucoma (Nighttime Sinus only)

Ask a doctor or pharmacist before use if you are
  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin

When using these products
  • do not use more than directed

In addition, when using Nighttime Sinus:

  • 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 and tranquilizers may increase drowsiness

Stop use and ask a doctor if
  • redness or swelling is present
  • pain or nasal congestion gets worse or lasts more than 7 days
  • you get nervous, dizzy or sleepless
  • fever gets worse or lasts more than 3 days
  • new symptoms occur

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. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions
  • take only as recommended - see Liver warning
  • do not exceed 6 doses per 24 hours

Nighttime Sinus

adults and children 12 years and over

2 softgels with water every

4-6 hours
children 4 to under 12 yearsask a doctor
children under 4 yearsdo not use

Daytime Sinus

adults and children 12 years and over

2 softgels with water every

4 hours
children 4 to under 12 yearsask a doctor
children under 4 yearsdo not use
  • when using other Daytime or Nighttime products, carefully read each label to insure correct dosing

Other information
  • store at 20°-25°C (68°-77°F)

Inactive ingredients

Nighttime Sinus edible ink, FD&C blue no. 1, gelatin, glycerin, mannitol, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol

Daytime Sinus edible ink, FD&C yellow no. 6, gelatin, glycerin, mannitol, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

SEE NEW WARNINGS INFORMATION

DayTime Sinus

Non-Drowsy Relief of Your Worst Sinus Symptoms

PAIN RELIEVER / NASAL DECONGESTANT

Acetaminophen - sinus headache and pain

Phenylephrine HCl - sinus pressure and congestion

ANTIHISTAMINE FREE

ALCOHOL FREE

NiteTime Sinus

Nighttime Relief of Your Worst Sinus Symptoms

PAIN RELIEVER/ANTIHISTAMINE/NASAL DECONGESTANT

Acetaminophen - sinus headache and pain

Doxylamine Succinate - runny nose

Phenylephrine HCl - sinus pressure and congestion

ALCOHOL FREE

COMPARE TO VICKS® NYQUIL® SINUS LIQUICAPS® AND VICKS® DAYQUIL® SINUS LIQUICAPS® active ingredients

RELIEVES: SINUS CONGESTION / SINUS HEADACHE / SINUS PRESSURE

DOES NOT CONTAIN PSEUDOEPHEDRINE

DayTime and NiteTime Sinus Carton Image 1

DayTime and NiteTime Sinus Carton Image 2

DAYTIME NITETIME SINUS 
acetaminophen, doxylamine succinate , phenylephrine hcl kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41250-515
Packaging
#Item CodePackage Description
1NDC:41250-515-051 KIT (KIT) in 1 CARTON
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 12 BLISTER PACK 20 
Part 22 BLISTER PACK 20 
Part 1 of 2
NITETIME SINUS 
acetaminophen, doxylamine succinate , phenylephrine hcl capsule, liquid filled
Product Information
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
DOXYLAMINE SUCCINATE (DOXYLAMINE) DOXYLAMINE SUCCINATE6.25 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 
GELATIN 
GLYCERIN 
MANNITOL 
POLYETHYLENE GLYCOLS 
POVIDONE 
PROPYLENE GLYCOL 
WATER 
SORBITAN 
SORBITOL 
Product Characteristics
ColorBLUE (transparent) Scoreno score
ShapeCAPSULE (softgel) Size20mm
FlavorImprint CodeL247
Contains    
Packaging
#Item CodePackage Description
12 BLISTER PACK (BLISTER PACK) in 1 KIT
110 CAPSULE, LIQUID FILLED (TABLET) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/10/2007
Part 2 of 2
DAYTIME SINUS 
acetaminophen, phenylephrine hcl capsule, liquid filled
Product Information
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
FD&C YELLOW NO. 6 
GELATIN 
GLYCERIN 
MANNITOL 
POLYETHYLENE GLYCOLS 
POVIDONE 
PROPYLENE GLYCOL 
WATER 
SORBITAN 
SORBITOL 
Product Characteristics
ColorORANGE (light;transparent) Scoreno score
ShapeCAPSULE (softgel) Size20mm
FlavorImprint CodeL565
Contains    
Packaging
#Item CodePackage Description
12 BLISTER PACK (BLISTER PACK) in 1 KIT
110 CAPSULE, LIQUID FILLED (TABLET) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/10/2007
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/10/2007
Labeler - Meijer Distribution Inc (006959555)

Revised: 02/2012
 
Meijer Distribution Inc

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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