Night time cold and flu original liquid

Active ingredients (in each 30 ml dose cup)

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

Purpose

Pain reliever/fever reducer
Cough suppressant
Antihistamine

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

Warnings

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

  • 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

  • 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

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

When using this product

  • 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

  • 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,

ask a health professional before use.

Keep out of reach of children.

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

  • 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 12 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 30 mL dose cup contains:potassium 5 mg, sodium 37 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

acesulfame potassium, alcohol, anhydrous citric acid, D&C yellow no. 10, FD&C green no. 3, FD&C yellow no. 6, 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

Ingredients and appearance - Product information

Night time cold and flu original liquid- Acetaminophen, doxylamine succinate, and dextromethorphan hbr

Product information

Product Type Human OTC Drug Label Item Code (Source) NDC: 68998-531
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Acetaminophen ( UNII: 362O9ITL9D)( Acetaminophen - UNII: 362O9ITL9D ) 650 mgin 30 mL
Dextromethorphan hydrobromide ( UNII: 9D2RTI9KYH)( Dextromethorphan - UNII: 7355X3ROTS ) 30 mgin 30 mL
Doxylamine succinate ( UNII: V9BI9B5YI2)( Doxylamine - UNII: 95QB77JKPL ) 12.5 mgin 30 mL

Inactive Ingredients

Ingredient Name Code
Acesulfame potassium ( UNII: 23OV73Q5G9)
Alcohol ( UNII: 3K9958V90M)
Anhydrous citric acid ( UNII: XF417D3PSL)
D&c yellow no. 10 ( UNII: 35SW5USQ3G)
Fd&c green no. 3 ( UNII: 3P3ONR6O1S)
Fd&c yellow no. 6 ( UNII: H77VEI93A8)
Anise ( UNII: 21C2F5E8RE)
Menthol, unspecified form ( UNII: L7T10EIP3A)
High fructose corn syrup ( UNII: XY6UN3QB6S)
Polyethylene glycol 1600 ( UNII: 1212Z7S33A)
Propylene glycol ( UNII: 6DC9Q167V3)
Water ( UNII: 059QF0KO0R)
Saccharin sodium ( UNII: SB8ZUX40TY)
Sodium citrate, unspecified form ( UNII: 1Q73Q2JULR)

Product Characteristics

Color GREEN Flavor MENTHOL

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 68998-531-16 355mL in 1 BOTTLE 2017/07/20

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC MONOGRAPH FINAL part341 USA 2017/07/20

Labeler - Marc Glassman, Inc.( 094487477)

Establishment

Name ID/FEI Business Operations
Marc Glassman, Inc. 094487477 MANUFACTURE( 68998-531)

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

NDC 68998-531-16
*Compare to the active ingredients
in Vicks ®NyQuil ®Cold & Flu
Marcs ®


Original
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)