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Cold and Flu Relief Nighttime by ASSURED / DOLLAR TREE (Greenbrier International, Inc.)

Medically reviewed on November 8, 2017

Dosage form: liquid
Ingredients: ACETAMINOPHEN 650mg in 30mL, DEXTROMETHORPHAN HYDROBROMIDE 30mg in 30mL, DOXYLAMINE SUCCINATE 12.5mg in 30mL
Labeler: ASSURED / DOLLAR TREE (Greenbrier International, Inc.)
NDC Code: 33992-0344

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.

Drug Facts

Active ingredients (in each 30 mL)

Acetaminophen 650 mg

Dextromethorphan HBr 30 mg

Doxylamine succinate 12.5 mg

Purposes

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Uses
  • temporarily relieves these common cold/flu symptoms:
    • headache
    • minor aches and pains
    • sore throat
    • runny nose and sneezing
    • fever
    • 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 4,000 doses 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, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult 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.

Ask a doctor before use if you have
  • liver disease
  • glaucoma
  • a breathing problem or chronic cough that that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • trouble urinating due to an enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)

Ask a doctor or pharmacist before use if you are taking
  • sedatives or tranquilizers
  • the blood thinning drug warfarin

When using this product
  • 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 worseor 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 (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions
  • do not take more than directed (see Overdose warning)
  • do not take more than 4 doses in any 24-hours period
  • measure only with dosing cup provided. Do not use any other dosing device.
  • mL= milliliter
  • keep dosing cup with product
  • adults and children 12 years and over: 30 mL every 6 hours
  • children under 12 years of age: do not use
  • When using other Day Time or Night Time products, carefully read each label to ensure correct dosing

Other information
  • each 30 mL contains: potassium 5 mg
  • each 30 mL contains: Sodium 19 mg
  • store between 20-25ºC (68-77ºF). Do not refrigerate.

Inactive ingredients

acesulfame potassium, alcohol, citric acid, D&C yellow #10, FD&C green #3, FD&C yellow #6,, flavor,high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST 

Principal Display Panel

COMPARE TO ACTIVE INGREDIENTS IN VICKS® NYQUIL® COLD & FLU*

MULTI-SYMPTOM

Nitetime

Cold & Flu Relief

Acetaminophen 650 mg -  Pain Reliever / Fever Reducer

Dextromethorphan HBr 30 mg - Cough Suppressant

Doxylamine succinate 12.5 mg - Antihistamine

  • Alcohol 10%

Relieves Fever, Headache, Sore Throat, Cough, Minor Aches & Pains, Runny Nose & Sneezing

AGES 12 +

FL OZ (mL)

*This product is not manufactured or distributed by The Procter & Gamble Company. Vicks® and NyQuil® are registered trademarks of The Procter & Gamble Company.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.

DISTRIBUTED BY

GREENBRIER INTERNATIONAL, INC,

500 VOLVO PARKWAY

CHESAPEAKE, VA 23320

Product Label

ASSUREDN NiteTime Cold & Flu Relief Original Liquid

COLD AND FLU RELIEF  NIGHTTIME
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33992-0344
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN650 mg  in 30 mL
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE30 mg  in 30 mL
DOXYLAMINE SUCCINATE (DOXYLAMINE) DOXYLAMINE SUCCINATE12.5 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL 
WATER 
ACESULFAME POTASSIUM 
ALCOHOL 
ANHYDROUS CITRIC ACID 
HIGH FRUCTOSE CORN SYRUP 
POLYETHYLENE GLYCOLS 
SACCHARIN SODIUM 
TRISODIUM CITRATE DIHYDRATE 
D&C YELLOW NO. 10 
FD&C GREEN NO. 3 
FD&C YELLOW NO. 6 
Packaging
#Item CodePackage Description
1NDC:33992-0344-4118 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34110/31/2017
Labeler - ASSURED / DOLLAR TREE (Greenbrier International, Inc.) (610322518)

 
ASSURED / DOLLAR TREE (Greenbrier International, Inc.)

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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