NIGHTTIME COLD AND FLU

NIGHTTIME COLD AND FLU

Drug Labeling and Warnings

Drug Details

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NIGHTTIME COLD AND FLU - acetaminophen, dextromethorphan hydrobromide and doxylamine succinate liquid 
Bi-Mart

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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NIGHTTIME COLD AND FLU

Drug Facts

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 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  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 6 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 25°C (68° to 77°F)

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

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 

Alcohol 10%

12 FL OZ (355 mL)



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

NIGHTTIME COLD AND FLU 
acetaminophen, dextromethorphan hydrobromide and doxylamine succinate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 37835-952
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg  in 30 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE30 mg  in 30 mL
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE12.5 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
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
ColorGREENScore    
ShapeSize
FlavorANISE, MENTHOLImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 37835-952-30355 mL in 1 BOTTLE; Type 0: Not a Combination Product01/11/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34101/11/2018
Labeler - Bi-Mart (027630078)
Registrant - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
Aurohealth LLC078728447MANUFACTURE(37835-952)

Revised: 1/2018
 
Bi-Mart


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