Nighttime cold and flu liquid

Drug facts

Active ingredients (in each30 mL dose cup)

Acetaminophen, USP650 mg
Dextromethorphan HBr, USP30 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 throatand 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


  • morethan 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 Parkinsons 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 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 as well asfor 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) every6 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

  • each30 mL dose cup contains:potassium5 mg, sodium 37 mg
  • store at 20 to 25C (68 to 77F)

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

Questions or comments?

call 1-800-935-6737

Distributed by:
BI-MART
Eugene, OR 97402

Ingredients and appearance - Product information

Nighttime cold and flu liquid- Acetaminophen, dextromethorphan hydrobromide and doxylamine succinate

Product information

Product Type Human OTC Drug Label Item Code (Source) NDC: 37835-952
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 400 ( UNII: B697894SGQ)
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: 37835-952-30 355mL in 1 BOTTLE 2018/01/11

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC MONOGRAPH FINAL part341 USA 2018/01/11

Labeler - Bi-Mart( 027630078)

Establishment

Name ID/FEI Business Operations
Bi-Mart 027630078 MANUFACTURE( 37835-952)

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

BI-MART

Compare to the active ingredients
in Vicks ®NyQuil ®Cold & Flu*

NIGHTTIME
COLD & FLU

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


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

Alcohol10%

12 FL OZ (355 mL)