NiteTime Sinus

Meijer Distribution Inc

Meijer Distribution, Inc. NiteTime Sinus Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredients (in each softgel)
• Purpose
• NiteTime Sinus Uses
• Warnings
  • Do not use
  • Ask a doctor before use if you have
  • Ask a doctor or pharmacist before use if you are
  • When using this product
  • Stop use and ask a doctor if
  • If pregnant or breast-feeding,
  • Keep out of reach of children.
• Directions
• Inactive ingredients
• Questions or comments?
• Principal Display Panel

FULL PRESCRIBING INFORMATION

Active ingredients (in each softgel)

Acetaminophen 325 mg

Doxylamine succinate 6.25 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever

Antihistamine

Nasal decongestant

NiteTime Sinus Uses

temporarily relieves nasal and sinus symptoms:

• •sinus pain
• •headache
• •nasal and sinus congestion
• •runny nose and sneezing

Warnings

Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 8 softgels (2,600 mg acetaminophen) in 24 hours. Severe liver damage may occur if you take

• •more than 4,000 mg of acetaminophen in 24 hours
• •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.
• •if you have ever had an allergic reaction to this product or any of its ingredients
• •to make a child sleepy

Ask a doctor before use if you have

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

Ask a doctor or pharmacist before use if you are

• •taking sedatives or tranquilizers
• •taking the blood thinning drug warfarin

When using this product

• •do not use more than directed
• •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
• •you get nervous, dizzy or sleepless
• •fever gets worse or lasts more than 3 days
• •new symptoms occur
• •pain or nasal congestion gets worse or lasts more than 7 days

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 directed – see Liver warning
• •do not exceed 4 doses per 24 hours

• •when using other Daytime or Nighttime products, carefully read each label to insure correct dosing

Inactive ingredients

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

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to Vicks® NyQuil® Sinex® active ingredients

SEE NEW WARNINGS AND DIRECTIONS

Liquid Capsules

NiteTime Sinus

Acetaminophen, Doxylamine Succinate, Phenylephrine HCl

Multi-Symptom

Pain Reliever, Antihistamine

Nasal Decongestant

24 Softgels

Relief of: sinus headache and pain, runny nose, sinus pressure and congestion