HEALTHY ACCENTS DAYTIME - acetaminophen, dextromethorphan hydrobromide and phenylephrine hydrochloride capsule, liquid filled 
DZA Brands LLC

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:

Warnings

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

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

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

Other information

Inactive ingredients

edible ink, FD&C red no. 40, FD&C yellow no. 6, gelatin, glycerin, mannitol, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol

Questions or comments?

1-866-322-2439

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Compare to Vicks® DayQuil® LiquiCaps® active ingredients

non-drowsy

daytime

cold & flu

pain reliever - fever reducer - cough suppressant

nasal decongestant

aches, fever (acetaminophen)

cough (dextromethorphan HBr)

nasal congestion (phenylephrine HCl)

alcohol & antihistamine free

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HEALTHY ACCENTS DAYTIME 
acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55316-994
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 
MANNITOL 
POLYETHYLENE GLYCOLS 
POVIDONE 
PROPYLENE GLYCOL 
WATER 
SORBITAN 
SORBITOL 
Product Characteristics
ColorORANGEScore no score
ShapeCAPSULESize20mm
FlavorImprint Code L994
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:55316-994-531 BLISTER PACK ( BLISTER PACK) in 1 CARTONcontains a BLISTER PACK
112 CAPSULE, LIQUID FILLED ( CAPSULE) in 1 BLISTER PACKThis package is contained within the CARTON (55316-994-53)
2NDC:55316-994-602 BLISTER PACK ( BLISTER PACK) in 1 CARTONcontains a BLISTER PACK
210 CAPSULE, LIQUID FILLED ( CAPSULE) in 1 BLISTER PACKThis package is contained within the CARTON (55316-994-60)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/24/2008

Labeler - DZA Brands LLC (090322194)

Revised: 03/2012 DZA Brands LLC