Day time cold and flu non-drowsy liquid

Active ingredients (in each15 ml tablespoon)

Acetaminophen, USP 325 mg
Dextromethorphan HBr, USP 10 mg
Phenylephrine HCl, USP 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 & bronchial irritation
  • sore throat
  • headache
  • minor aches & pains
  • fever

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, 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 you have

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

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
  • symptoms get worse or last 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 (1-800-222-1222). Prompt medical attention is critical for adults & for children even if you do not notice any signs or symptoms.

Directions

  • take only as directed - see Overdose warning
  • use dose cup or tablespoon (TBSP)
  • do not exceed 4 doses (60 mL) (4 TBSP) per 24 hours
  • mL = milliliter; TBSP = tablespoon

adults & children 12 years & over
30 mL (2 TBSP) every 4 hours
children 6 to under 12 years
15 mL (1 TBSP) every 4 hours
children 4 to under 6 years
ask a doctor
children under 4 years
do not use
  • when using other Daytime or Nighttime products, carefully read each label to ensure correct dosing

Other information

  • each 15 mL contains:sodium 49 mg
  • store at 20 to 25C (68 to 77F)
  • Tamper Evident:Do not use if printed shrinkband is missing or broken. Failure to follow these warnings could result in serious consequences

Inactive ingredients

anhydrous citric acid, carboxymethylcellulose sodium, edetate disodium, FD & C Yellow no. 6, flavor, glycerin, menthol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol, sucralose


*This product is not manufactured or distributed by Procter & Gamble distributor of Vicks ®DayQuil ®Cold & Flu, Multi-Symptom Relief.

Otc - questions section

Distributed by:
Marc Glassman, Inc.
West 130th Street
Cleveland, OH 44130

Ingredients and appearance - Product information

Day time cold and flu non-drowsy liquid- Acetaminophen, dextromethorphan hbr, phenylephrine hcl

Product information

Product Type Human OTC Drug Label Item Code (Source) NDC: 68998-530
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Acetaminophen ( UNII: 362O9ITL9D)( Acetaminophen - UNII: 362O9ITL9D ) 325 mgin 15 mL
Dextromethorphan hydrobromide ( UNII: 9D2RTI9KYH)( Dextromethorphan - UNII: 7355X3ROTS ) 10 mgin 15 mL
Phenylephrine hydrochloride ( UNII: 04JA59TNSJ)( Phenylephrine - UNII: 1WS297W6MV ) 5 mgin 15 mL

Inactive Ingredients

Ingredient Name Code
Anhydrous citric acid ( UNII: XF417D3PSL)
Carboxymethylcellulose sodium, unspecified form ( UNII: K679OBS311)
Edetate disodium ( UNII: 7FLD91C86K)
Fd&c yellow no. 6 ( UNII: H77VEI93A8)
Orange ( UNII: 5EVU04N5QU)
Glycerin ( UNII: PDC6A3C0OX)
Menthol, unspecified form ( UNII: L7T10EIP3A)
Propylene glycol ( UNII: 6DC9Q167V3)
Water ( UNII: 059QF0KO0R)
Saccharin sodium anhydrous ( UNII: I4807BK602)
Sodium benzoate ( UNII: OJ245FE5EU)
Sodium chloride ( UNII: 451W47IQ8X)
Sodium citrate, unspecified form ( UNII: 1Q73Q2JULR)
Sorbitol ( UNII: 506T60A25R)
Sucralose ( UNII: 96K6UQ3ZD4)

Product Characteristics

Color ORANGE (Orange to Reddish Brown) Flavor ORANGE

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 68998-530-16 355mL in 1 BOTTLE 2017/07/14

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC MONOGRAPH FINAL part341 USA 2017/07/14

Labeler - Marc Glassman, Inc.( 094487477)

Establishment

Name ID/FEI Business Operations
Marc Glassman, Inc. 094487477 MANUFACTURE( 68998-530)

Package label-principal display panel -12 fl oz (355 ml bottle)

NDC 68998-530-16
*Compare to the active ingredients
in Vicks® DayQuil® Cold & Flu
Multi-Symptom Relief
Marcs ®

non-drowsy
Day Time
COLD & FLU
Acetaminophen (Pain reliever/fever reducer)
Phenylephrine HCl (Nasal decongestant)
Dextromethorphan HBr (Cough suppressant)


  • Aches, Fever & Sore Throat
  • Nasal Congestion
  • Cough

Alcohol Free/Antihistamine Free

12 FL OZ (355 mL)