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NiteTime Sinus

Dosage form: capsule, liquid filled
Ingredients: ACETAMINOPHEN 325mg, DOXYLAMINE SUCCINATE 6.25mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: Meijer Distribution Inc
NDC Code: 41250-247

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. NiteTime Sinus Drug Facts

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. 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

adults & children 12 yrs & over

2 softgels with water every 4 – 6 hours

children 4 to under 12 yrs

ask a doctor

children under 4 yrs

do not use

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

Liquid Capsules

NiteTime Sinus

Pain Reliever, Antihistamine, Nasal Decongestant

Acetaminophen, Doxylamine Succinate, Phenylephrine HCl

Multi-Symptom Relief

Alcohol Free

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

24 Softgels

NITETIME SINUS 
acetaminophen, doxylamine succinate, phenylephrine hcl capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41250-247
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 
POLYETHYLENE GLYCOLS 
POVIDONES 
PROPYLENE GLYCOL 
WATER 
Product Characteristics
ColorBLUE (transparent) Scoreno score
ShapeCAPSULE (softgel) Size20mm
FlavorImprint CodeL247
Contains    
Packaging
#Item CodePackage Description
1NDC:41250-247-622 BLISTER PACK in 1 CARTON
112 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/16/2013
Labeler - Meijer Distribution Inc (006959555)

Revised: 07/2014
 
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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