DAY TIME SINUS- acetaminophen and phenylephrine hydrochloride capsule, liquid filled 
Meijer Distribution Inc

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.

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Meijer Distribution, Inc. DayTime Sinus Drug Facts

Active ingredients (in each softgel)

Acetaminophen 325 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever

Nasal decongestant

Uses

temporarily relieves sinus symptoms:

•
sinus pain
•
headache
•
nasal and sinus congestion

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

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

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin

When using this product

do not use more than directed

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 hrs

adults & children 12 yrs & over

2 softgels with water every 4 hrs

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

Other information

•
store at 20°-25°C (68°-77°F)

Inactive ingredients

edible ink, FD&C yellow no. 6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution

Questions or comments?

1-800-719-9260

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Compare to Vicks® DayQuil® Sinex® active ingredients

SEE NEW WARNINGS AND DIRECTIONS

Non-Drowsy

Liquid Capsules

DayTime Sinus

Acetaminophen 325 mg, Phenylephrine HCl 5 mg

Pain Reliever

Nasal Decongestant

24 Softgels

Relief of: sinus headache, sinus pain & sinus congestion

Meijer DayTime Sinus 1.jpg
Meijer DayTime Sinus 2.jpg
DAY TIME SINUS 
acetaminophen, phenylephrine hcl capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:41250-565
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
FD&C YELLOW NO. 6 
GELATIN 
GLYCERIN 
POLYETHYLENE GLYCOLS 
POVIDONES 
PROPYLENE GLYCOL 
WATER 
SORBITAN 
SORBITOL 
Product Characteristics
ColorORANGE (light;transparent) Scoreno score
ShapeCAPSULE (softgel) Size20mm
FlavorImprint Code L565
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41250-565-622 in 1 CARTON
112 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34112/21/2012
Labeler - Meijer Distribution Inc (006959555)

Revised: 9/2013
Document Id: 9f58a4cb-c40d-4712-ab27-72a798a8166c
Set id: 9f58a4cb-c40d-4712-ab27-72a798a8166c
Version: 1
Effective Time: 20130919
 
Meijer Distribution Inc