Advanced Rx - Puregen - Non-drowsy Daytime Cold & Flu Relief (80513-301)

Advanced Rx - Puregen - Non-drowsy Daytime Cold & Flu Relief (80513-301)
SPL v5
SPL
SPL Set ID fa1a4d86-87bb-0c50-e053-6394a90a56e2
Route
ORAL
Published
Effective Date 2023-04-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (10 mg) Diphenhydramine (5 mg) Acetaminophen (325 mg)
Inactive Ingredients
Fd&c Red No. 40 Polawax Polysorbate Fd&c Yellow No. 6 Povidone Titanium Dioxide Glycerin Gelatin Type B Bovine (160 Bloom) Polyethylene Glycol, Unspecified Water Sorbitol Solution Propylene Glycol

Identifiers & Packaging

Pill Appearance
Imprint: IS1 Shape: oval Color: red Size: 20 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-04-24

Description

Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer Cough suppressant Nasal decongestant


Medication Information

Purpose

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Description

Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenylephrine HCl 5 mg

Uses

Temporarily relieves common cold and flu symptoms:

  • nasal congestion
  • cough due to minor throat and bronchial irritation
  • headache
  • minor aches and pains
  • fever
  • sore throat
Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults and for children even if you do not notice any signs or symptoms.

Section 51945-4

Warnings

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

  • more than 4 doses 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

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, lasts 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 products containing acetaminophen (prescription or non-prescription). 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

Ask a doctor before use if you have

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough as occurs with smoking, asthma, or emphysema

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

When using this product, do not use more than directed.

Stop use and ask a doctor if

  • you get nervous, dizzy or sleepless
  • pain, nasal congestion or cough gets worse or last 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.

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

Directions
  • take only as directed
  • do not exceed 4 doses per 24 hours
adults and children 12 years and over take 2 softgels with water every 4 hours
children 4 to under 12 years ask a doctor
children under 4 years do not use

Questions?

call toll-free 1-800-630-8895

Other Information
  • store at room temperature
Inactive Ingredients

FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, polysorbate, povidone, propylene glycol, purified water,

sorbitol sorbitan solution, titanium dioxide.

Active Ingredient (in Each Softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg


Structured Label Content

Uses (USES)

Temporarily relieves common cold and flu symptoms:

  • nasal congestion
  • cough due to minor throat and bronchial irritation
  • headache
  • minor aches and pains
  • fever
  • sore throat
Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults and for children even if you do not notice any signs or symptoms.

Section 51945-4 (51945-4)

Purpose (PURPOSE)

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Warnings (WARNINGS)

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

  • more than 4 doses 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

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, lasts 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 products containing acetaminophen (prescription or non-prescription). 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

Ask a doctor before use if you have

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough as occurs with smoking, asthma, or emphysema

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

When using this product, do not use more than directed.

Stop use and ask a doctor if

  • you get nervous, dizzy or sleepless
  • pain, nasal congestion or cough gets worse or last 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.

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

Directions (DIRECTIONS)
  • take only as directed
  • do not exceed 4 doses per 24 hours
adults and children 12 years and over take 2 softgels with water every 4 hours
children 4 to under 12 years ask a doctor
children under 4 years do not use

Questions? (QUESTIONS?)

call toll-free 1-800-630-8895

Other Information (OTHER INFORMATION)
  • store at room temperature
Inactive Ingredients (INACTIVE INGREDIENTS)

FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, polysorbate, povidone, propylene glycol, purified water,

sorbitol sorbitan solution, titanium dioxide.

Active Ingredient (in Each Softgel) (ACTIVE INGREDIENT (IN EACH SOFTGEL))

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)