Night-time Liquid
FDA Label NDC 53942-501

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Demoulas Market Basket for the product Night-time (NDC 53942-501). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding drug factsactive ingredients (in each 30 ml dose cup), purpose, keep out of reach of children, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Factsactive Ingredients (In Each 30 Ml Dose Cup)

Acetaminophen 650 mg  

Dextromethorphan HBr 30 mg  

Doxylamine Succinate 12.5 mg  

Purpose


Pain reliever/fever reducer   

Cough suppressant   

Antihistamine  

Keep Out Of Reach Of Children

Keep out of reach of children.

Uses

temporarily relieves cold/flu symptoms:

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

Warnings

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

  • more than 4 doses in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product.

    • Allergy Alert: Acetaminophen may causesevere skin reactions. Symptoms may include:

    • skinreddening
    • blisters
    • rash

      • If a skin reactions occurs, stop 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
  • to make a child sleepy

Ask A Doctor Before Use If You Have

  • a sodium restricted diet
  • 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

Ask A Doctor Or Pharmacist Before Use

  • if you are taking sedatives or tranquilizers
  • if you are taking the blood thinning drug warfarin

When Using This Product

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

Stop Use And Ask A Doctor If

  •  redness or swelling is present
  • symptoms do not get better within 7 days or are accompanied by a fever
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • cough lasts more than 7 days, comes back, or occurs with fever, rash, headache that lasts
    • These could be signs of a serious condition.

If Pregnant Or Breast-Feeding

ask a health professional before use.

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. Quick 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 recommended-see Overdose warnings
  • Use dose cup or tablespoon (TBSP)
  • do not exceed 4 doses per 24 hours
  • If taking Night Time at night and Day Time during the day, limit total to 4 doses per 24 hours
    • Aptapharmamb Nighttime Ms2 Label (Aptapharma Mbnighttimems2)

    Aptapharmamb Nighttime Ms2 Label (Aptapharma Mbnighttimems2)


Other Information

  • each 30 mL dose cup contains:
  • sodium 45 mg
  • store at room temperature

Inactive Ingredients

citric acid, D and C yellow No. 10, FD and C Green No. 3, FD and C Yellow No. 6, flavor, glycerin, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate, sucrose

Questions?

Call weekdays

1-877-798-5944

Market Basket Night-Time Product Label

MARKET BASKET®

"MORE FOR YOUR DOLLAR"

* COMPARE TO THE ACTIVE INGREDIENTS IN VICKS® NYQUIL®

NIGHT-TIME

MULTI-SYMPTOM COLD/FLU  RELIEF


Acetaminophen - Pain Reliever/Fever Reducer

Dextromethorphan HBr - Cough Suppressant

Doxylamine Succinate - Antihistamine

Original Flavor

12 FL OZ (354 mL)

DO NOT USE IF IMPRINTED SHRINK BAND IS MISSING OR BROKEN

Failure to followthese warnings could result in serious complications

*This product is not manufactured or distributed by Proctor & Gamble, distributor of Vicks® Nyquil®   LR-002

Made in the USA

DISTRIBUTED BY DEMOULAS SUPERMARKETS INC.

875 EAST STREET - TEWKSBURY, MA 01876

LR - 034 REV 01



* Please review the disclaimer below.