Dg Day Time Cold And Flu Formula And Night Time Cold And Flu Formula Kit
FDA Label NDC 51013-168

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Puracap Pharmaceutical Llc for the product Dg Day Time Cold And Flu Formula And Night Time Cold And Flu Formula (NDC 51013-168). 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 active ingredients (in each softgel), purposes, 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

Active Ingredients (In Each Softgel)

Active ingredients for Day Time (in each softgel)

Acetaminophen 325 mg 
Dextromethorphan hydrobromide 10 mg
Phenylephrine hydrochloride 5 mg

Active ingredients for Night Time (in each softgel)

Acetaminophen 325 mg
Dextromethorphan hydrobromide 10 mg
Doxylamine succinate 6.25 mg
Phenylephrine hydrochloride 5 mg

Purposes

DG Day Time Cold & Flu Formula

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

DG Night Time Cold & Flu Formula

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant

Uses

  • temporarily relieves these symptoms due to a cold or flu:
    • minor aches and pains
    • headache
    • nasal and sinus congestion
    • cough
    • sore throat
    • runny nose and sneezing (Night Time only)
    • temporarily reduces fever

Warnings

Liver warning

These products contain acetaminophen. Severe liver damage may occur if you take

  • more than 10 softgels in 24 hours, which is the maximum daily amount for this product
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

    • 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.

    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.

      Do not use to sedate children(Night Time only).

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.
  • if you have ever had an allergic reaction to this product or any of its ingredients
  • in children under 12 years of age  

Ask A Doctor Before Use If You Have

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • cough with excessive phlegm (mucus)
  • difficulty in urination due to enlargement of the prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema   
  • glaucoma (Night Time only)
  • a breathing problem such as emphysema or chronic bronchitis (Night Time only)

Ask A Doctor Or Pharmacist Before Use If You Are

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers (Night Time only)

When Using This Product

  • do not exceed recommended dosage 
    • In addition when using Night Time 
    • may cause marked drowsiness
    • avoid alcoholic drinks
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • be careful when driving a motor vehicle or operating machinery
    • excitability may occur, especially in children

Stop Use And Ask A Doctor If

  • pain, cough, or nasal congestion 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.

    • nervousness, dizziness, or sleeplessness occurs  

If Pregnant Or Breast-Feeding,

 ask a health professional before use.

Keep Out Of Reach Of Children.

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

  • do not take more than the recommended dose
  • adults and children 12 years and over: take 2 softgels with water every 4 hours. Do not exceed 10 softgels in 24 hours or as directed by a doctor.
  • children under 12 years: do not use

Other Information

  • store at room temperature. Avoid excessive heat.

Inactive Ingredients (Day Time)

FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol,  povidone, propylene glycol, purified water, sorbitol special, and white edible ink

Inactive Ingredients (Night Time)

D&C yellow #10, FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special, and white edible ink

Questions Or Comments?

Call: 1-888-309-9030 

Principal Display Panel

DG Day and Night Cold and Flu Formula 

NDC 51013-168-08

*Compare to the active ingredients in Alka-Seltzer PLUS® Day and Night Cold and Flu Formula

* Please review the disclaimer below.