NIGHT TIME COLD and FLU CHERRY

Manufacturer
Marc Glassman, Inc. | Aurohealth LLC
Effective date
2020-11-26
Label type
Human OTC Drug Label
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 23:03:40

Label at a glance#

ProductNIGHT TIME COLD and FLU CHERRY
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE
Label structure15 sections

Indications and uses

temporarily relieves common cold/flu symptoms: cough due to minor throat and bronchial irritation sore throat headache minor aches and pains fever runny nose and sneezing

Dosage and administration

take only as directed - see Overdose warning use dose cup or tablespoon (TBSP) do not exceed 4 doses (120 mL) (8 TBSP) per 24 hours mL = milliliter; TBSP = tablespoon adults & children 12 years & over 30 mL (2 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

Storage and handling

each 30 mL dose cup contains: potassium 5 mg, sodium 38 mg store at 20° to 25°C (68° to 77°F) Tamper Evident: Do not use if printed shrinkband is missing or broken. Failure to follow these warnings could result in serious consequences

Label contents#

Full prescribing information#

Active ingredients (in each 30 mL dose cup)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen, USP 650 mg
Dextromethorphan HBr, USP 30 mg
Doxylamine succinate, USP 12.5 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer
Cough suppressant
Antihistamine

Uses

INDICATIONS & USAGE SECTION

temporarily relieves common cold/flu symptoms:

  • cough due to minor throat and bronchial irritation
  • sore throat
  • headache
  • minor aches and pains
  • fever
  • runny nose and sneezing

Warnings

WARNINGS SECTION

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

  • more than 4,000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 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

OTC - DO NOT USE SECTION

  • 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.
  • to make a child sleep

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • liver disease
  • glaucoma
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema
  • trouble urinating due to enlarged prostate gland
  • a sodium-restricted diet

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin

When using this product

OTC - WHEN USING SECTION

  • do not use more than directed
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery
  • alcohol, sedatives, and tranquilizers may increase drowsiness

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • pain 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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Overdose warning: Taking more than the recommended dose 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 as well as for children even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

  • take only as directed - see Overdose warning
  • use dose cup or tablespoon (TBSP)
  • do not exceed 4 doses (120 mL) (8 TBSP) per 24 hours
  • mL = milliliter; TBSP = tablespoon
adults & children 12 years & over
30 mL (2 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

STORAGE AND HANDLING SECTION

  • each 30 mL dose cup contains: potassium 5 mg, sodium 38 mg
  • store at 20° to 25°C (68° to 77°F)

Tamper Evident: Do not use if printed shrinkband is missing or broken.
Failure to follow these warnings could result in serious consequences

Inactive ingredients

INACTIVE INGREDIENT SECTION

acesulfame potassium, alcohol, anhydrous citric acid, FD&C blue no. 1, FD&C red no. 40, flavors, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate

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

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 12 FL OZ (355 mL Bottle)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68998-532-16
*Compare to the active ingredients
in Vicks® NyQuil® Cold & Flu
Marcs®


cherry
Night Time
COLD & FLU

Acetaminophen (Pain reliever/fever reducer)
Doxylamine succinate (Antihistamine)
Dextromethorphan HBr (Cough suppressant)

  • Aches, Fever & Sore Throat 
  • Sneezing, Runny Nose 
  • Cough

Alcohol 10%

12 FL OZ (355 mL)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 12 FL OZ (355 mL Bottle)PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 12 FL OZ (355 mL Bottle)

Products#

Every source-derived product name is available through these pages.

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68998-53268998-532-16

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
c8d80b02-3540-49b6-b908-2268a81f1f080046fac2-df34-4c8e-b0c0-5f1fcd5c15b12020-11-26WarningsExact identifier
spl id: c8d80b02-3540-49b6-b908-2268a81f1f08
spl set id: 0046fac2-df34-4c8e-b0c0-5f1fcd5c15b1

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.