Next Cold And Flu
FDA Label NDC 50066-603

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Genomma Lab Usa, Inc. for the product Next Cold And Flu (NDC 50066-603). 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 softgel), purpose, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, 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 Softgel)

Acetaminophen 325 mg
Dextromethorphan HBr 15 mg
Doxylamine succinate 6.25 mg

Purpose

Pain reliever/fever reducer
Cough suppressant
Antihistamine

Uses

temporarily relieves common cold and 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 cantains acetaminophen. Severe liver damage may occur if you take

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

    • Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

    • skin reddening
    • blisters
    • rash

      • If skin reaction occurs, stop use and seek medical help right away.

      Sore throat warning: If sore throat is severe, persists 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 an MAOI drug. If you do not know if 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

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 exceed recommended dosage
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • avoid alcoholic drink
  • 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
  • a skin reaction occurs. 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.

Keep out of reach of children. In case of accidental 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 directed (see Warnings)
  • do not exceed 4 doses per 24 hours
  • Adults and children 12 years and over:
    take 2 softgels with water every 6 hours
  • Children 4 to under 12 years: Ask a doctor

    • Children under 4 years: Do not use

    • When using Day Time ot Night Time products, carefully read each label to ensure correct dosing

Other Information

  • store at room temperature 20-25°C (68-77°F)

Inactive Ingredients

FD&C Blue # 1, D&C Yellow # 10, Gelatin, Glycerin, Polyethylene glycol, Povvidone, Propylene glycol, Purified water, Sorbital sorbitan solution, Titanium dioxide.

Questions?

Call 1-877-99-Genom (43666)
Weekdays from 8am to 6 pm

Next Cold & Flu Nighttime Product Label

NEXT
COLD & FLU

NIGHTTIME RELIEF

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

    • Acetaminophen/
    Dextromethorphan HBr / Doxylamine succinate

    Tamper evident: Do not use if blisters are torn or open

    Distributed by:
    Genomma Lab USA, Inc.
    Houston, TX 77027

    Made in India

    BX-056

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