NITETIME SINUS- acetaminophen, doxylamine succinate and phenylephrine hydrochloride capsule, liquid filled

NiteTime Sinus by

Drug Labeling and Warnings

NiteTime Sinus by is a Otc medication manufactured, distributed, or labeled by MEIJER, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each softgel)

Acetaminophen 325 mg

Doxylamine succinate 6.25 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever

Antihistamine

Nasal decongestant

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. 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

• to make a child sleep
• 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.

Ask a doctor before use if you have

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

Ask a doctor or pharmacist before use if you are

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

When using this product

• do not exceed recommended dosage
• 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

• nervousness, dizziness, or sleeplessness occur
• pain or nasal congestion gets worse or lasts more than 7 days
• fever gets worse or lasts more than 3 days
• redness or swelling is present
• new symptoms occur

These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

Overdose warning: Taking more than the recommended dose can cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Directions

• do not use more than directed (see Overdose warning )
• do not take more than 4 doses in 24 hours
• adults and children 12 years and over: take 2 softgels with water every 4 hours
• swallow whole; do not crush, chew, or dissolve
• children under 12 years: do not use
• when using other DayTime and NiteTime products, carefully read each label to ensure correct dosing

Other information

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

Inactive ingredients

edible white ink, FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to Vicks® NyQuil® Sinex® LiquiCaps® active ingredients†

Liquid Capsules

NiteTime Sinus

Pain Reliever, Antihistamine, Nasal Decongestant

Acetaminophen, Doxylamine succinate, Phenylephrine HCl

Multi-Symptom Relief

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

Softgels

DIST. BY MEIJER DISTRIBUTION, INC.

2929 WALKER AVE NW

GRAND RAPIDS, MI 49544

www.meijer.com

Product of Canada

†This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademark Vicks® NyQuil® Sinex® LiquiCaps®.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

Package Label

Meijer NiteTime Sinus Multi-Symptom Relief Softgels

INGREDIENTS AND APPEARANCE

NITETIME SINUS 
acetaminophen, doxylamine succinate and phenylephrine hydrochloride capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41250-101
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	6.25 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 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)
SORBITAN (UNII: 6O92ICV9RU)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	BLUE	Score	no score
Shape	CAPSULE	Size	20mm
Flavor		Imprint Code	47A
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41250-101-24	2 in 1 CARTON	09/14/2010
1		12 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	09/14/2010

Labeler - MEIJER, INC. (006959555)