Resfriol D

Resfriol D
SPL v2
SPL
SPL Set ID b3c229a4-c772-70fb-e053-2a95a90a72db
Route
ORAL
Published
Effective Date 2019-08-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg) Chlorpheniramine (4 mg) Phenylephrine (10 mg)
Inactive Ingredients
Sodium Benzoate Sodium Starch Glycolate Type A Potato Talc Silicon Dioxide Magnesium Stearate Starch, Corn Povidone K30

Identifiers & Packaging

Pill Appearance
Imprint: S78 Shape: round Color: white Size: 13 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-08-26

Description

Acetaminophen 500mg Chlorpheniramine Maleate 4mg Phenylephrine HCl 10mg


Medication Information

Warnings and Precautions

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

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.

Ask a doctor before use if you have:

  • Liver disease
  • High blood pressure
  • Thyroid disease
  • Diabetes
  • Trouble urinating due to enlarged prostate gland
  • A breathing problem such as emphysema or chronic bronchitis

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 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.

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

Keep out of reach of children.

Indications and Usage

Temporarily relieves these symptoms of hay fever or other respiratory allergies:

  • Headache
  • Nasal congestion
  • Sinus congestion & pressure
  • Runny nose and sneezing
  • Minor aches & pain

Temporarily relieves these additional symptoms of hay fever:

  • itching of the nose or throat
  • itchy, watery eyes
  • helps clear nasal passages
  • helps decongest sinus opening and passages
Dosage and Administration

  • 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

Acetaminophen 500mg Chlorpheniramine Maleate 4mg Phenylephrine HCl 10mg

Section 34088-5

OVERDOSE WARNING: Read directions carefully. 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 50565-1

Keep out of reach of children.

Section 51727-6

magnesium stearate, povidone, silicon dioxide, sodium benzoate, sodium starch glycolate, starch, talc

Section 51945-4

Section 55105-1

Pain reliever/fever reducer

Antihistamine

Nasal decongestant

Section 55106-9

Acetaminophen 500mg

Chlorpheniramine Maleate 4mg

Phenylephrine HCl 10mg

Section 60561-8

store at room temperature between 20-25°C (68-77ºF)

avoid excessive heat and humidity


Structured Label Content

Indications and Usage (34067-9)

Temporarily relieves these symptoms of hay fever or other respiratory allergies:

  • Headache
  • Nasal congestion
  • Sinus congestion & pressure
  • Runny nose and sneezing
  • Minor aches & pain

Temporarily relieves these additional symptoms of hay fever:

  • itching of the nose or throat
  • itchy, watery eyes
  • helps clear nasal passages
  • helps decongest sinus opening and passages
Dosage and Administration (34068-7)

  • 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)

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

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.

Ask a doctor before use if you have:

  • Liver disease
  • High blood pressure
  • Thyroid disease
  • Diabetes
  • Trouble urinating due to enlarged prostate gland
  • A breathing problem such as emphysema or chronic bronchitis

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 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.

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

Keep out of reach of children.

Section 34088-5 (34088-5)

OVERDOSE WARNING: Read directions carefully. 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 50565-1 (50565-1)

Keep out of reach of children.

Section 51727-6 (51727-6)

magnesium stearate, povidone, silicon dioxide, sodium benzoate, sodium starch glycolate, starch, talc

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Pain reliever/fever reducer

Antihistamine

Nasal decongestant

Section 55106-9 (55106-9)

Acetaminophen 500mg

Chlorpheniramine Maleate 4mg

Phenylephrine HCl 10mg

Section 60561-8 (60561-8)

store at room temperature between 20-25°C (68-77ºF)

avoid excessive heat and humidity


Advanced Ingredient Data


Raw Label Data

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