Resfriol D

Resfriol D
SPL v3
SPL
SPL Set ID 0e9c96b9-41ac-0faf-e063-6294a90a8ab5
Route
ORAL
Published
Effective Date 2024-01-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Phenylephrine (10 mg) Acetaminophen (500 mg) Chlorpheniramine (4 mg)
Inactive Ingredients
Crospovidone, Unspecified Talc Silicon Dioxide Magnesium Stearate Povidone, Unspecified Microcrystalline Cellulose

Identifiers & Packaging

Pill Appearance
Imprint: A15 Shape: round Color: white Size: 13 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-01-10

Description

ACTIVE INGREDIENTS (in each tablet) Acetaminophen 500 mg Chlorpheniramine Maleate 4 mg Phenylephrine HCl 10 mg


Medication Information

Warnings and Precautions

Warnings

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

  • more than 6 tablets in 24 hours, which is the maximum daily amount for this product
  • with other drugs contains 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, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult doctor promptly

Indications and Usage

Uses:

  • temporarily relieves these symptoms of hay fever or other respiratory allergies:
  • headache
  • sinus congestion & pressure
  • nasal congestion
  • runny nose and sneezing
  • minor aches & pain
  • temporarily relieves these additional symptoms of hay fever:
  • nose or throat itching
  • itchy, watery eyes
  • helps clear nasal passages
  • helps decongest sinus opening and passages
Dosage and Administration

Directions:

  • Do not take more than directed - see overdose warning
  • Swallow whole; do not crush, chew or dissolve
  • Do not exceed 6 tablets per 24 hours
Adults and children 12 years of age & over 1 tablet with water every 4-6 hours as needed
Children 4 to 12 years of age Ask a doctor
Children under 4 years of age Do not use

Description

ACTIVE INGREDIENTS (in each tablet) Acetaminophen 500 mg Chlorpheniramine Maleate 4 mg Phenylephrine HCl 10 mg

Section 42229-5

Exclusively distributed by:

OPMX

San Diego, CA 92154

Phone: 619-600-5632

Section 44425-7

Other information:

  • Store at room temperature between 20-25°C (68-77ºF); excrusions permitted between 15°C - 30°C (59°F - 86°F)
  • Avoid excessive heat and humidity
  • Tamper Evident: do not use if package or blister unit is open or shows any sing of tampering.
Section 50565-1

Keep out of reach of children.

Overdose warning:Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 50566-9

Stop use and ask a doctor if:

  • nervousness, dizziness, or sleeplessness occur
  • pain or nasal congestion gets worse or lasts more than 7 days
  • fever gets worse or last more than 3 days
  • redness or swelling is present
  • new symptoms occur

These could be signs of a serious condition.

Section 50567-7

When using this product:

  • do not use more than directed
  • excitability may occur, especially in children
  • drowsiness may occur
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery
Section 50568-5

Ask a doctor or pharmacist before use if you are:

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers
Section 50569-3

Ask a doctor before use if you have:

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • glaucoma
  • diabetes
  • trouble urinating due to enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis
Section 50570-1

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
  • to make a child sleepy
Section 51727-6

Inactive ingredients: Microcrystalline cellulose, Polyvinylpyrrolidone,Crospovidone, Magnesium stearate, Colloidal silicon dioxide, Purified talc

Section 53413-1

Questions or comments?

Call: (619) 600-5632 (Mon-Fri 9am-5pm EST) or https://www.opmx.us

Section 53414-9

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

Section 55105-1

PURPOSE

Pain Reliever/Fever Reducer

Antihistamine

Nasal decongestant

Section 55106-9

ACTIVE INGREDIENTS (in each tablet)

Acetaminophen 500 mg

Chlorpheniramine Maleate 4 mg

Phenylephrine HCl 10 mg

Principal Display Panel 2 Tablets

NDC 69729-323-27

RESFRIOL D

Actaminophen 500 mg - Pain reliever/Fever Reducer

Chlorpheniramine Maleate 4 mg - Antihistamine

Phenylephrine HCl 10 mg - Nasal decongestant

Cold/Allergy Relief

To relieve common symptoms of Cold & Allergy such as:

Headache

Sneezing

Nasal Congestion

Itchy, Watery Eyes and Runny Nose ​

​2 Tablets

Principal Display Panel 12 Tablets

NDC 69729-323-37

RESFRIOL D

Actaminophen 500 mg - Pain reliever/Fever Reducer

Chlorpheniramine Maleate 4 mg - Antihistamine

Phenylephrine HCl 10 mg - Nasal decongestant

Cold/Allergy Relief

To relieve common symptoms of Cold & Allergy such as:

Headache

Sneezing

Nasal Congestion

Itchy, Watery Eyes and Runny Nose ​

​12 Tablets (6 Pouches of 2 tablets)

Principal Display Panel 144 Tablets

NDC 69729-323-38

RESFRIOL D

Actaminophen 500 mg - Pain reliever/Fever Reducer

Chlorpheniramine Maleate 4 mg - Antihistamine

Phenylephrine HCl 10 mg - Nasal decongestant

Cold/Allergy Relief

To relieve common symptoms of Cold & Allergy such as:

Headache

Sneezing

Nasal Congestion

Itchy, Watery Eyes and Runny Nose ​

​144 Tablets (72 Pouches of 2 tablets)


Structured Label Content

Indications and Usage (34067-9)

Uses:

  • temporarily relieves these symptoms of hay fever or other respiratory allergies:
  • headache
  • sinus congestion & pressure
  • nasal congestion
  • runny nose and sneezing
  • minor aches & pain
  • temporarily relieves these additional symptoms of hay fever:
  • nose or throat itching
  • itchy, watery eyes
  • helps clear nasal passages
  • helps decongest sinus opening and passages
Dosage and Administration (34068-7)

Directions:

  • Do not take more than directed - see overdose warning
  • Swallow whole; do not crush, chew or dissolve
  • Do not exceed 6 tablets per 24 hours
Adults and children 12 years of age & over 1 tablet with water every 4-6 hours as needed
Children 4 to 12 years of age Ask a doctor
Children under 4 years of age Do not use

Warnings and Precautions (34071-1)

Warnings

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

  • more than 6 tablets in 24 hours, which is the maximum daily amount for this product
  • with other drugs contains 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, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult doctor promptly

Section 42229-5 (42229-5)

Exclusively distributed by:

OPMX

San Diego, CA 92154

Phone: 619-600-5632

Section 44425-7 (44425-7)

Other information:

  • Store at room temperature between 20-25°C (68-77ºF); excrusions permitted between 15°C - 30°C (59°F - 86°F)
  • Avoid excessive heat and humidity
  • Tamper Evident: do not use if package or blister unit is open or shows any sing of tampering.
Section 50565-1 (50565-1)

Keep out of reach of children.

Overdose warning:Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 50566-9 (50566-9)

Stop use and ask a doctor if:

  • nervousness, dizziness, or sleeplessness occur
  • pain or nasal congestion gets worse or lasts more than 7 days
  • fever gets worse or last more than 3 days
  • redness or swelling is present
  • new symptoms occur

These could be signs of a serious condition.

Section 50567-7 (50567-7)

When using this product:

  • do not use more than directed
  • excitability may occur, especially in children
  • drowsiness may occur
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery
Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are:

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers
Section 50569-3 (50569-3)

Ask a doctor before use if you have:

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • glaucoma
  • diabetes
  • trouble urinating due to enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis
Section 50570-1 (50570-1)

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
  • to make a child sleepy
Section 51727-6 (51727-6)

Inactive ingredients: Microcrystalline cellulose, Polyvinylpyrrolidone,Crospovidone, Magnesium stearate, Colloidal silicon dioxide, Purified talc

Section 53413-1 (53413-1)

Questions or comments?

Call: (619) 600-5632 (Mon-Fri 9am-5pm EST) or https://www.opmx.us

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

PURPOSE

Pain Reliever/Fever Reducer

Antihistamine

Nasal decongestant

Section 55106-9 (55106-9)

ACTIVE INGREDIENTS (in each tablet)

Acetaminophen 500 mg

Chlorpheniramine Maleate 4 mg

Phenylephrine HCl 10 mg

Principal Display Panel 2 Tablets (PRINCIPAL DISPLAY PANEL - 2 Tablets)

NDC 69729-323-27

RESFRIOL D

Actaminophen 500 mg - Pain reliever/Fever Reducer

Chlorpheniramine Maleate 4 mg - Antihistamine

Phenylephrine HCl 10 mg - Nasal decongestant

Cold/Allergy Relief

To relieve common symptoms of Cold & Allergy such as:

Headache

Sneezing

Nasal Congestion

Itchy, Watery Eyes and Runny Nose ​

​2 Tablets

Principal Display Panel 12 Tablets (PRINCIPAL DISPLAY PANEL - 12 TABLETS)

NDC 69729-323-37

RESFRIOL D

Actaminophen 500 mg - Pain reliever/Fever Reducer

Chlorpheniramine Maleate 4 mg - Antihistamine

Phenylephrine HCl 10 mg - Nasal decongestant

Cold/Allergy Relief

To relieve common symptoms of Cold & Allergy such as:

Headache

Sneezing

Nasal Congestion

Itchy, Watery Eyes and Runny Nose ​

​12 Tablets (6 Pouches of 2 tablets)

Principal Display Panel 144 Tablets (PRINCIPAL DISPLAY PANEL - 144 TABLETS)

NDC 69729-323-38

RESFRIOL D

Actaminophen 500 mg - Pain reliever/Fever Reducer

Chlorpheniramine Maleate 4 mg - Antihistamine

Phenylephrine HCl 10 mg - Nasal decongestant

Cold/Allergy Relief

To relieve common symptoms of Cold & Allergy such as:

Headache

Sneezing

Nasal Congestion

Itchy, Watery Eyes and Runny Nose ​

​144 Tablets (72 Pouches of 2 tablets)


Advanced Ingredient Data


Raw Label Data

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