DAYTIME SINUS NON DROWSY- acetaminophen and phenylephrine hydrochloride capsule, liquid filled 
Chain Drug Consortium, LLC (Premier Value)

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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Active ingredients (in each softgel)

Acetaminophen 325 mg

Phenylephrine HCl 5 mg

Purposes

Pain reliever

Nasal decongestant

Uses

temporarily relieves sinus symptoms:

  • sinus pain
  • headache
  • nasal and sinus congestion

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 any 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.

Ask a doctor before use if you have

  • liver disease
  • heart disease
  • thyroid disease
  • diabetes
  • high blood pressure
  • difficulty in 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 exceed the recommended dosage

Stop use and ask a doctor if

  • new symptoms occur
  • redness or swelling is present
  • you get nervous, dizzy or sleepless
  • fever gets worse or lasts more than 3 days
  • symptoms do not get better within 7 days or are accompanied by a fever

These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health care professional before use.

Keep out of reach of children.

Overdose warning: Taking more than directed could cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt 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 exceed 4 doses in 24 hours
  • when using other Daytime and Nighttime products, carefully read each label to ensure correct dosing
 adults and children 12 years of age and over take 2 softgels with water every 4 hours
 children 4 to under 12 years of age ask a doctor
 children under 4 years of age do not use

Other information

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

Inactive ingredients

FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special, white edible ink

Questions or comments?

call toll free 1-877-753-3935 Monday- Friday 9AM- 5PM EST

Principal Display Panel

*Compare to active ingredients in Vicks® Dayquil® Sinex®

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

Non- Drowsy Daytime sinus

Acetaminophen 325 mg, Phenylephrine HCl 5 mg

Relieves:

  • sinus headache
  • pain
  • congestion

THIS PRODUCT IS PACKAGED IN A CHILD RESISTANT AND TAMPER EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT.

Distributed by: CHAIN DRUG CONSORTIUM, LLC.

3301 NW BOCA RATON BLVD, SUITE 101

BOCA RATON, FL 33431

Product Label

Premier value daytime sinus softgels

Non-Drowsy Daytime Sinus

DAYTIME SINUS  NON DROWSY
acetaminophen and phenylephrine hydrochloride capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-200
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 
SORBITOL 
Product Characteristics
ColorORANGEScoreno score
ShapeCAPSULESize20mm
FlavorImprint Code 48A
Contains    
Packaging
#Item CodePackage Description
1NDC:68016-200-162 in 1 CARTON
18 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34111/15/2012
Labeler - Chain Drug Consortium, LLC (Premier Value) (101668460)

Revised: 10/2012
 
Chain Drug Consortium, LLC (Premier Value)