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Daytime Cold and Flu Relief Non Drowsy

Medically reviewed on January 31, 2018

Dosage form: capsule, liquid filled
Ingredients: ACETAMINOPHEN 325mg, DEXTROMETHORPHAN HYDROBROMIDE 10mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: Chain Drug Consortium, LLC
NDC Code: 68016-598

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 (CDC) Cold & Flu Relief Drug Facts

Active ingredients (in each capsule)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Uses

temporarily relieves common cold/flu symptoms:

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

Warnings

Liver warnings: 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 daily while using this product

Sore throat warning: If sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see a doctor promptly.

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
  • liver disease
  • heart disease
  • thyroid disease
  • diabetes
  • high blood pressure
  • trouble urinating due to an enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough as occurs with smoking, asthma or emphysema

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 doctor if
  • you get nervous, dizzy or sleepless
  • symptoms get worse or lasts more than 5 days (children) or 7 days (adults)
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • cough comes back, or occurs with rash or headache that lasts.

These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children

Overdose warning: Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults & children even if you do not notice any signs or symptoms.

Directions
  • take only as directed – see Overdose warning
  • do not exceed 4 doses per 24 hours
adults & children 12 yrs & over2 capsules with water every 4 hrs
children 4 to under 12 yrsask a doctor
children under 4 yrsdo not use
  • when using other Daytime or Nighttime products, carefully read each label to ensure correct dosing

Other information
  • store at controlled room temperature 15°C to 30°C (59°F to 86°F)
  • avoid excessive heat

Inactive ingredients

FD&C Red No. 40, FD&C Yellow No. 6, gelatin, glycerine, polyethylene glycol 400, povidone K12, propylene glycol, purified water, sorbitol sorbitan solution, white ink.

Questions or comments?

1-800-706-5575

Principal Display Panel

MULTI SYMPTOM

NONDROWSY • DAYTIME

Cold & Flu Relief

Acetaminophen/Aches/ Fever/ Sore throat

Dextromethorphan HBr/ Cough

Phenylephrine/ Nasal Congestion

16 Liquid Caps Compare to Vicks® DayQuil® LiquiCaps® active ingedients‡

DAYTIME COLD AND FLU RELIEF   NON DROWSY
acetaminophen, dextromethorphan hydrobromide, phenylephrine capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-598
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN ) DEXTROMETHORPHAN HYDROBROMIDE10 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 40 
FD&C YELLOW NO. 6 
GELATIN 
GLYCERIN 
POLYETHYLENE GLYCOLS 
POVIDONES 
PROPYLENE GLYCOL 
WATER 
SORBITOL 
Product Characteristics
ColorORANGEScoreno score
ShapeOVALSize20mm
FlavorImprint Code95A
Contains    
Packaging
#Item CodePackage Description
1NDC:68016-598-162 BLISTER PACK in 1 CARTON
18 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
2NDC:68016-598-242 BLISTER PACK in 1 CARTON
212 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/12/2015
Labeler - Chain Drug Consortium, LLC (101668460)
Establishment
NameAddressID/FEIOperations
Catalent Ontario Limited248441727analysis(68016-598), manufacture(68016-598)
Establishment
NameAddressID/FEIOperations
Catalent Ontario Limited243944050manufacture(68016-598), analysis(68016-598)
Establishment
NameAddressID/FEIOperations
Legacy Pharmaceutical Packaging143213275pack(68016-598)

 
Chain Drug Consortium, LLC

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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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