Nite-timecold/flu Cherry Liquid
FDA Label NDC 57243-502

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Salado Sales, Inc. for the product Nite-timecold/flu Cherry (NDC 57243-502). 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

Failure to follow these warnings could result in serious consequences

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, 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.

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

    • adults & children 12 years and over                     30 mL (2 TBSP) every 6 hours

    children 4 to under 12 years                                ask a doctor

    children under 4 years                                          do not use

    • If taking Nite Time at night and Day Time during the day, limit total to 4 doses per 24 hours

Other Information

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

Inactive Ingredients

citric acid, FD and C Blue No. 1, FD&C Red No. 40, flavor, glycerin, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate, sucrose

Nite Time Cherry Product Label

Compare to VICKS® NYQUIL® active ingredients   

CVP® CONSUMER VALUE PRODUCTS

Nite-Time COLD/FLU Medicine

Multi-Symptom CHERRY FLAVOR

Acetaminophen • Aches, Fever & Sore Throat

Dextromethorphan • Cough

Doxylamine Succinate • Sneezing, Runny nose

6 FL OZ (177 mL)

DO NOT USE IF IMPRINTED SHRINK BAND IS MISSING OR BROKEN

*This product is not manufactured or distributed by Proctor and Gamble, distributor of Vicks® Nyquil®   LR-003

Questions? Call weekdays from 9:30am to 4:30pm EST 1-877-795-5944

LR-003 Rev 02

Distributed by:
Salado Sales, Inc.
P.O. Box 6115 Temple, TX 76503  
www.saladosales.com

LOT:        EXP:

Peel Here  DRUG FACTS CONTINUED ON BACK

CHERRY FLAVOR Nite-Time Multi-Symptom COLD/FLU Medicine

  • Antihistamine
  • Cough Suppressant
  • Pain Reliever
  • Fever Reducer

* Please review the disclaimer below.