DAY TIME COLD AND FLU NON DROWSY- acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride liquid 
Marc Glassman, 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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Drug Facts

Active ingredients (in each 15 mL, 1 tablespoon)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Uses

temporarily relieves these common cold/flu symptoms:

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

Warnings

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

  • more than 6 doses (12 tablespoons or 180 mL) in 24 hours for adults
  • more than 5 doses (5 tablespoons or 75 mL) in 24 hours for children 6-12 years old
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks everyday 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

  • 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.
  • with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • if you are allergic to acetaminophen or any of the inactive ingredients in this product

Ask a doctor before use if the user has

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

Ask a doctor or pharmacist before use if the user is

taking the blood thinning drug warfarin.

When using this product,

  • avoid alcoholic drinks
  • do not use more than directed (see overdose warning)

Stop use and ask a doctor if

  • redness or swelling is present
  • new symptoms occur
  • nervousness, dizziness or sleeplessness occurs
  • fever gets worse or lasts more than 3 days
  • pain or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
  • 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 the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately. 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 overdose warning)
  • do not exceed 5 doses (children) or 6 doses (adults) per 24 hours
  • use dosage cup provided
  • tbsp=tablespoon, mL=milliliter
 age dose
 adults and children 12 years and over 2 tablespoons (30 mL) every 4 hours
 children 6 to 11 years 1 tablespoon (15 mL) every 4 hours
 children 4 to 5 years do not use unless directed by a doctor
 children under  years do not use
  •  When using Day Time and Night Time products, carefully read each label to ensure correct dosing

Other information

  • each 15 mL contains: sodium 71 mg
  • store at room temperature

Inactive ingredients

citric acid, FD&C yellow 6, flavor, glycerin, polyethylene glycol, purified water, saccharin sodium, sodium citrate, sucrose

Principal Display Panel

*Compare to active ingredients in Vicks® DayQuil®

non-drowsy

Day Time

Cold & Flu

Acetaminophen- Pain reliever/fever reducer

Dextromethorphan HBr- Cough suppressant

Phenylephrine HCl- Nasal Decongestant

  • For Ages 6 & Over
  • Alcohol Free
  • Antihistamine free

FL OZ (mL)

Failure to follow these warnings could result in serious consequences.

*This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademark Vicks®DayQuil®.

TAMPER EVIDENT: DO NOT USE IF SAFETY SEAL ON OR UNDER THE BOTTLE IS BROKEN OR MISSING.

Distributed by:

Marc Glassman, Inc.

West 130th Street

Cleveland, OH 44130

Product Label

Acetaminophen 325 mg, Dextromethorphan HBr 10 mg, Phenylephrine HCl 5 mg

Marc's Day Time Cold and Flu Liquid

DAY TIME COLD AND FLU  NON DROWSY
acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68998-311
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg  in 15 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 15 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
SUCROSE (UNII: C151H8M554)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68998-311-12355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/31/201412/30/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34108/31/201412/30/2021
Labeler - Marc Glassman, Inc. (094487477)

Revised: 11/2019
 
Marc Glassman, Inc.