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Western Family Foods Inc

Western Family Day Relief Sinus PE and Night Relief Sinus PE 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

day relief night relief sinus pe 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

day relief night relief sinus pe 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

Package/Label Principal Display Panel

SAVE when you buy DAY and NIGHT SINUS RELIEF

See New Warnings Information

LIQUID CAPS

Day Relief Sinus PE

NON-DROWSY RELIEF OF YOUR WORST SINUS SYMPTOMS

PAIN RELIEVER, NASAL DECONGESTANT

RELIEVES SINUS PRESSURE, SINUS HEADACHE, SINUS CONGESTION

ACETAMINOPHEN, PHENYLEPHRINE HCl

ALCOHOL FREE

ANTIHISTAMINE FREE

COMPARE TO VICKS® DAYQUIL® SINUS active ingredients

See New Warnings Information

LIQUID CAPS

Night Relief Sinus PE

NIGHTTIME RELIEF OF YOUR WORST SINUS SYMPTOMS

PAIN RELIEVER, ANTIHISTAMINE, NASAL DECONGESTANT

RELIEVES SINUS PRESSURE, SINUS HEADACHE, SINUS CONGESTION

ACETAMINOPHEN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCl

ALCOHOL FREE

COMPARE TO VICKS® NYQUIL® SINUS active ingredients

day relief night relief sinus pe
Day Relief Sinus PE and Night Relief Sinus PE Carton Image 1 Day Relief Sinus PE and Night Relief Sinus PE Carton Image 2

day relief night relief sinus pe

Acetaminophen, Doxylamine succinate , Phenylephrine HCl KIT

Product Information

Product Type Human otc drug label Item Code (Source) NDC:55312-515
Route of Administration DEA Schedule

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:55312-515-05 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2007-11-16


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Be sure to consult your doctor before taking any medication!
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