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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.

Active Ingredient

Acetaminophen 500mg

Chlorpheniramine Maleate 4mg

Phenylephrine HCl 10mg

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 60561-8

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

avoid excessive heat and humidity


Structured Label Content

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.

Active Ingredient (55106-9)

Acetaminophen 500mg

Chlorpheniramine Maleate 4mg

Phenylephrine HCl 10mg

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

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 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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