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DAYTIME SINUS AND CONGESTION by Chain Drug Consortium, LLC

Medically reviewed on Oct 12, 2018

Dosage form: capsule, liquid filled
Ingredients: ACETAMINOPHEN 325mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: Chain Drug Consortium, LLC
NDC Code: 68016-630

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.

Premier Value Daytime Sinus and Congestion Drug Facts

Active ingredient(s)

Acetaminophen 325 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever/Fever reducer

Nasal decongestant

Uses

  • temporarily relieves symptoms due to common cold
  • minor aches and pains
  • headache
  • fever
  • nasal congestion
  • sinus congestion & pressure
  • temporarily relieves symptoms due to hay fever or other upper respiratory allergies
  • minor aches and pains
  • headache
  • nasal congestion
  • sinus congestion & pressure

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 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
  • high blood pressure
  • thyroid disease
  • diabetes
  • 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

  • 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
  • • you get nervous, dizzy or sleepless

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. 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
  • do not exceed 4 doses per 24 hrs 
adults & children 12 yrs & over2 Liquid Caps with water every 4 hrs
children 4 to under 12 yrsask a doctor
children under 4 yrsdo not use

Other information

  • store at controlled room temperature 15°C to 30°C (59°F to 86°F)

Inactive ingredients

edible white ink, FD&C Yellow No. 6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water and sorbitol

Questions or comments?

1-800-706-5575

*This product is not manufactured or distributed by Procter & Gamble, distributor of Vicks® QlearQuilTM DayTime Sinus & Congestion Liquicaps®.

Principal Display Panel

Premier Value

Non-Drowsy

Daytime

Sinus & Congestion

NDC number 68016-630-16

16 Liquid Capsule

DAYTIME SINUS AND CONGESTION  
acetaminophen, phenylephrine hydrochloride capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-630
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 
POVIDONE K12 
PROPYLENE GLYCOL 
SORBITOL 
WATER 
Product Characteristics
ColorWHITEScoreno score
ShapeCAPSULESize16mm
FlavorImprint Code48A
Contains    
Packaging
#Item CodePackage Description
1NDC:68016-630-168 CARTON in 1 BLISTER PACK
12 CAPSULE, LIQUID FILLED in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/13/2015
Labeler - Chain Drug Consortium, LLC (101668460)
Establishment
NameAddressID/FEIOperations
Accucaps Industries Limited248441727analysis(68016-630), manufacture(68016-630)
Establishment
NameAddressID/FEIOperations
Accucaps Industries Limited Strathoy243944050analysis(68016-630), manufacture(68016-630)
Establishment
NameAddressID/FEIOperations
Legacy Pharmaceutical Packaging969852743pack(68016-630)

 
Chain Drug Consortium, LLC

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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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