Available Formats

• Active ingredients (in each 15 mL)

  Acetaminophen 325 mg

  Dextromethorphan HBr 10 mg

  Phenylephrine HCl 5 mg

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• Purpose

  Pain reliever/fever reducer

  Cough suppressant

  Nasal decongestant

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• 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

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• Warnings

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

  • adult takes more than 4,000 mg of acetaminophen in 24 hours

  • child takes more than 5 doses in 24 hours

  • taken with other drugs containing acetaminophen

  • adult has 3 or more alcoholic drinks every day while using this product

  Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening

  • blisters

  • rash

  If a skin reaction occurs, stop use and seek medical help right away.

  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.

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• 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.

  • if you have ever had an allergic reaction to this product or any of its ingredients

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• 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

  • cough that occurs with too much phlegm (mucus)

  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema

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• Ask a doctor or pharmacist before use if you are

  taking the blood thinning drug warfarin

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• When using this product

  do not use more than directed

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• Stop use and ask a doctor if

  • you get nervous, dizzy or sleepless

  • pain, nasal congestion or cough gets 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.

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• If pregnant or breast-feeding,

  ask a health professional before use.

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• Keep out of reach of children.

  Overdose warning: 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.

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• Directions

  • take only as directed – see Overdose warning

  • only use the dose cup provided

  • do not exceed 4 doses per 24 hrs

  adults & children 12 yrs & over	30 mL every 4 hrs
  children 6 to under 12 yrs	15 mL every 4 hrs
  children 4 to under 6 yrs	ask a doctor
  children under 4 yrs	do not use

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• Other information

  • each 15 mL contains: sodium 7 mg

  • store at 20-25 °C (68-77 °F)

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• Inactive ingredients

  butylated hydroxyanisole, edetate disodium, FD&C yellow no. 6, flavor, glycerin, menthol, monobasic sodium phosphate, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sucrose, xanthan gum

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• Questions or comments?

  1-866-322-2439

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• Principal Display Panel

  Compare to Vicks® DayQuil® Cold & Flu active ingredients

  non-drowsy

  daytime

  cold & flu

  pain reliever - fever reducer

  cough suppressant - nasal decongestant

  aches, fever, sore throat (acetaminophen)

  cough (dextromethorphan HBr)

  nasal congestion (phenylephrine HCl)

  SEE NEW WARNINGS

  NO GLUTEN

  12 FL OZ (335mL)

  alcohol & antihistamine free

  

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• INGREDIENTS AND APPEARANCE

  HEALTHY ACCENTS DAYTIME  acetaminophen, dextromethorphan hbr, phenylephrine hcl solution

  Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55316-656 Route of Administration ORAL

  Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg  in 15 mL DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg  in 15 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg  in 15 mL

  Inactive Ingredients Ingredient Name Strength BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)   EDETATE DISODIUM (UNII: 7FLD91C86K)   FD&C YELLOW NO. 6 (UNII: H77VEI93A8)   GLYCERIN (UNII: PDC6A3C0OX)   SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW)   POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)   PROPYLENE GLYCOL (UNII: 6DC9Q167V3)   WATER (UNII: 059QF0KO0R)   SACCHARIN SODIUM (UNII: SB8ZUX40TY)   SUCROSE (UNII: C151H8M554)   XANTHAN GUM (UNII: TTV12P4NEE)   MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)

  Product Characteristics Color ORANGE (clear) Score      Shape Size Flavor MENTHOL (with fruit) Imprint Code Contains

  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55316-656-30 177 mL in 1 BOTTLE; Type 0: Not a Combination Product 02/24/2008 2 NDC:55316-656-38 296 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/29/2008 3 NDC:55316-656-40 355 mL in 1 BOTTLE; Type 0: Not a Combination Product 09/20/2012 4 NDC:55316-656-34 237 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/22/2012

  Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 01/29/2008

  Labeler - DZA Brands LLC (090322194)

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