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Daytime Sinus by VALU MERCHANDISERS COMPANY

Medically reviewed on January 23, 2018

Dosage form: capsule, liquid filled
Ingredients: ACETAMINOPHEN 325mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: VALU MERCHANDISERS COMPANY
NDC Code: 63941-341

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.

Daytime Sinus Liquid Caps

ACTIVE INGREDIENTS (IN EACH SOFTGEL)

Acetaminophen 325mg

Phenylephrine HCI 5mg

PURPOSES

Pain Reliever

Nasal decongestant

USES

temporarily relieves common cold and flu symptoms:

  • nasal congestion
  • cough due to minor throat and bronchial irritation
  • sore throat
  • headache
  • minor aches and pains, fever

WARNINGS

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

  • more than 4 doses in 24 hours, which is the maximum daily amount for this product
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product.

Do Not Use
  • with any other products 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 Disease), or for 2 weeks after stopping the MAOI drugs. 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
  • trouble urinating due to 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 exceed recommended dosage

Stop use and ask a doctor if
  • you get nervous, dizzy or sleepless
  • symptoms get worse or last more than 7 days or are accompanied by a fever
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur

If pregnant or breast-feeding,

ask a health professional before use

Keep out of reach of children

In case of accidental overdose, contact a doctor or Poison Control Center immediately (1-800-222-1222). Taking more than the recommended dose (overdose) may cause liver damage. 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 Warnings)
  • do not exceed 4 doses per 24 hours
    Adults and children 12 years and over take 2 softgels with water every 4 hours
    Children 4 to under 12 years Ask a doctor
    Children under 4 years Do not use

OTHER INFORMATION
  • store at room temperature
  • do not use if blister is torn or open

INACTIVE INGREDIENTS

FD&C Yellow #6, gelatin, glycerin, polyethylene glycol 400, povidone, propylene glycol, purified water, sorbitol sorbitan, titanium dioxide.

QUESTIONS OR COMMENTS?

Call toll free 1-888-952-0050 Monday through Friday 9AM-5PM EST

PRINCIPAL DISPLAY PANEL

Multi-Symptom ∙ Sinus Relief

Now Drowsy

Acetaminophen/Phenylephrine HCI

Pain reliever/Fever Reducer/Nasal Decongestant

Alcohol free/Antihistamine Free

Keep outer carton for complete warnings and product information

Proudly Distributed by:

Valu Merchandisers, Co.

Kansas City, KS 66106

This product is packaged in a child resistant and tamper evidence package.

Use only if blisters are intact.

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

DAYTIME SINUS  
acetaminophen and phenylephrine hci capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63941-341
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 
WATER 
TITANIUM DIOXIDE 
SORBITOL 
PROPYLENE GLYCOL 
POVIDONE 
POLYETHYLENE GLYCOL 400 
Product Characteristics
ColororangeScoreno score
ShapeCAPSULESize23mm
FlavorImprint Code224
Contains    
Packaging
#Item CodePackage Description
1NDC:63941-341-861 BLISTER PACK (BLISTER PACK) in 1 BOX
112 CAPSULE, LIQUID FILLED (CAPSULE) in 1 BLISTER PACK
2NDC:63941-341-512 BLISTER PACK (BLISTER PACK) in 1 BOX
220 CAPSULE, LIQUID FILLED (CAPSULE) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/29/2012
Labeler - VALU MERCHANDISERS COMPANY (868703513)
Registrant - A&Z Pharmaceutical, Inc. (926820705)
Establishment
NameAddressID/FEIOperations
A&Z Pharmaceutical, Inc.926820705manufacture(63941-341), pack(63941-341)

 
VALU MERCHANDISERS COMPANY

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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