DAY TIME COLD AND FLU- acetaminophen, dextromethorphan hydrobromide and phenylephrine hydrochloride capsule, liquid filled 
HyVee 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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Active ingredient (in each softgel)

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

  • more than 12 softgels in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult 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 you have

  • 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 a doctor if

  • you get nervous, dizzy or sleepless
  • pain, nasal congestion or cough 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
  • 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.

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 recommended – see Liver warning
  • do not exceed 6 doses per 24 hours
adults and children 12 years and over2 softgels with water every 4 hours
children 4 to under 12 yearsask a doctor
children under 4 yearsdo not use
  • when using other Daytime or Nighttime products, carefully read each label to insure correct dosing

Inactive ingredients

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

Questions or comments?

1-800-719-9260

Principal Display Panel

SEE NEW WARNINGS INFORMATION

Compare to Vicks® DayQuil® Cold & Flu LiquiCaps® active ingredients

Day Time

Cold & Flu

Non Drowsy

Multi-Symptom Relief

Acetaminophen - Aches, Fever

Dextromethorphan HBr - Cough

Phenylephrine HCl - Nasal Congestion

ALCOHOL FREE • ANTIHISTAMINE FREE

Pain Reliever, Fever Reducer, Cough Suppressant, Nasal Decongestant

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Day Time Carton Image 1

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DAY TIME  COLD AND FLU
acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42507-215
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
BUTYLATED HYDROXYANISOLE 
BUTYLATED HYDROXYTOLUENE 
FD&C YELLOW NO. 6 
GELATIN 
GLYCERIN 
MANNITOL 
POVIDONE 
PROPYLENE GLYCOL 
WATER 
SORBITAN 
SORBITOL 
POLYETHYLENE GLYCOLS 
Product Characteristics
ColorORANGEScoreno score
ShapeCAPSULESize20mm
FlavorImprint Code L215
Contains    
Packaging
#Item CodePackage Description
1NDC:42507-215-531 in 1 CARTON
112 in 1 BLISTER PACK
2NDC:42507-215-602 in 1 CARTON
210 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/25/2011
Labeler - HyVee Inc (006925671)

Revised: 03/2011
 
HyVee Inc