Severe Sinus Congestion Allergy And Cough Formula

Severe Sinus Congestion Allergy And Cough Formula
SPL v3
SPL
SPL Set ID 36a4ec1f-50c3-4d61-ada9-987ccad3563c
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) Doxylamine (6.25 mg) Phenylephrine (5 mg)
Inactive Ingredients
D&c Yellow No. 10 Fd&c Blue No. 1 Gelatin Glycerin Polyethylene Glycol, Unspecified Povidone Propylene Glycol Water Sorbitol

Identifiers & Packaging

Pill Appearance
Imprint: PC22 Shape: capsule Color: green Size: 20 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-06-29

Description

Drug Facts

Purpose

Pain reliever/fever reducer Cough suppressant Antihistamine Nasal decongestant


Medication Information

Purpose

Pain reliever/fever reducer Cough suppressant Antihistamine Nasal decongestant

Description

Drug Facts

Uses
  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
  • runny nose
  • sneezing
  • itching of the nose or throat
  • itchy, watery eyes
  • temporarily relieves these symptoms due to a cold:
  • nasal congestion
  • sinus congestion and pressure
  • headache
  • minor aches and pains
  • cough


  • temporarily reduces fever
Section 42229-5

Drug Facts

Section 53414-9

If pregnant or breast-feeding,ask a health professional before use.

Purposes

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant

Warnings

Liver warning

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

  • more than 10 softgels in 24 hrs, 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

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.

Directions
  • do not take more than the recommended dose
  • adults and children 12 years and over: take 2 softgelss 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.
Inactive Ingredients

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

When Using This Product
  • do not exceed recommended dosage
  • 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.

Active Ingredient (in Each Softgel)

Acetaminophen 325 mg

Dextromethorphan hydrobromide 10 mg

Doxylamine succinate 6.25 mg

Phenylephrine hydrochloride 5 mg

Ask A Doctor Before Use If You Have
  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • glaucoma
  • cough with excessive phlegm (mucus)
  • a breathing problem such as emphysema or chronic bronchitis
  • difficulty in urination due to enlargement of the prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
Principal Display Panel Carton Label

DG Severe Sinus Congestion Allergy & Cough Formula 20 Softgels

*Compare to the active ingredients in Alka-Seltzer PLUS® Severe Sinus Congestion, Allergy & Cough

NDC 51013-169-08

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

Structured Label Content

Uses
  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
  • runny nose
  • sneezing
  • itching of the nose or throat
  • itchy, watery eyes
  • temporarily relieves these symptoms due to a cold:
  • nasal congestion
  • sinus congestion and pressure
  • headache
  • minor aches and pains
  • cough


  • temporarily reduces fever
Section 42229-5 (42229-5)

Drug Facts

Section 53414-9 (53414-9)

If pregnant or breast-feeding,ask a health professional before use.

Purposes

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant

Warnings

Liver warning

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

  • more than 10 softgels in 24 hrs, 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

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.

Directions
  • do not take more than the recommended dose
  • adults and children 12 years and over: take 2 softgelss 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.
Inactive Ingredients (Inactive ingredients)

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? (Questions or comments?)

Call: 1-888-309-9030

When Using This Product (When using this product)
  • do not exceed recommended dosage
  • 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.

Active Ingredient (in Each Softgel) (Active ingredient (in each softgel))

Acetaminophen 325 mg

Dextromethorphan hydrobromide 10 mg

Doxylamine succinate 6.25 mg

Phenylephrine hydrochloride 5 mg

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
  • glaucoma
  • cough with excessive phlegm (mucus)
  • a breathing problem such as emphysema or chronic bronchitis
  • difficulty in urination due to enlargement of the prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
Principal Display Panel Carton Label (Principal Display Panel - Carton Label)

DG Severe Sinus Congestion Allergy & Cough Formula 20 Softgels

*Compare to the active ingredients in Alka-Seltzer PLUS® Severe Sinus Congestion, Allergy & Cough

NDC 51013-169-08

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

Advanced Ingredient Data


Raw Label Data

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