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daytime nitetime sinus

Meijer Distribution Inc

Meijer Distribution, Inc. DayTime and NiteTime Sinus Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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

daytime nitetime sinus 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 years ask a doctor
children under 4 years do not use

Daytime Sinus

adults and children 12 years and over

2 softgels with water every

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

daytime nitetime sinus 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 nitetime sinus
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 Type Human otc drug label Item Code (Source) NDC:41250-515
Route of Administration DEA Schedule

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:41250-515-05 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2007-08-10


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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