Day Time Cold & Flu Formula And Night Time Cold & Flu Formula

Day Time Cold & Flu Formula And Night Time Cold & Flu Formula
SPL v3
SPL
SPL Set ID cb68eef0-b027-4bf1-b78f-f31844a8c06c
Route
ORAL
Published
Effective Date 2019-11-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Dextromethorphan (10 mg) Phenylephrine (5 mg) Doxylamine (6.25 mg)
Inactive Ingredients
Fd&c Red No. 40 Fd&c Yellow No. 6 Gelatin Glycerin Polyethylene Glycol, Unspecified Povidone Propylene Glycol Water Sorbitol D&c Yellow No. 10 Fd&c Blue No. 1

Identifiers & Packaging

Pill Appearance
Imprint: PC22 Shape: capsule Color: orange Color: green Size: 20 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-06-15

Description

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

Purpose

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


Medication Information

Purpose

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

Description

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

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
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

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).
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
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  
Other Information
  • store at room temperature. Avoid excessive heat.
Questions Or Comments?

Call: 1-888-309-9030 

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  
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.

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

If Pregnant Or Breast Feeding, 

 ask a health professional before use.

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

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)
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

Principal Display Panel Carton Label

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

Ask A Doctor Or Pharmacist Before Use If You Are
  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers (Night Time only)

Structured Label Content

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
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

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).
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
Do Not Use (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  
Other Information (Other information)
  • store at room temperature. Avoid excessive heat.
Questions Or Comments? (Questions or comments?)

Call: 1-888-309-9030 

When Using This Product (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 (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  
Keep Out of Reach of Children. (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.

Inactive Ingredients (day Time) (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

If Pregnant Or Breast Feeding,  (If pregnant or breast-feeding, )

 ask a health professional before use.

Inactive Ingredients (night Time) (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

Ask A Doctor Before Use If You Have (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)
Active Ingredients (in Each Softgel) (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

Principal Display Panel Carton Label (Principal Display Panel - Carton Label)

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

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)
  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers (Night Time only)

Advanced Ingredient Data


Raw Label Data

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