Medique @ Home Decorel Forte

Medique @ Home Decorel Forte
SPL v5
SPL
SPL Set ID e648f017-9e30-df6c-e053-2995a90adcd0
Route
ORAL
Published
Effective Date 2022-09-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (100 mg) Dextromethorphan (10 mg) Phenylephrine (5 mg) Acetaminophen (325 mg)
Inactive Ingredients
Starch, Corn Crospovidone Fd&c Yellow No. 6 Microcrystalline Cellulose Polyvinyl Alcohol, Unspecified Stearic Acid Titanium Dioxide Sodium Starch Glycolate Type A Potato Talc Maltodextrin Magnesium Stearate Polyethylene Glycol, Unspecified Povidone, Unspecified Silicon Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: 44;546 Shape: capsule Color: orange Size: 17 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-09-26

Description

Drug Facts


Medication Information

Warnings and Precautions

Warnings

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

  • more than 4,000 mg of acetaminophen in 24 hours
  • 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:

  • blisters
  • rash
  • skin reddening

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 a doctor promptly.

Indications and Usage

Uses

Temporarily relieves these symptoms due to the common cold:

  • headache
  • nasal congestion
  • cough
  • minor aches and pains
  • sore throat
  • sinus congestion and pressure
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make cough more productive

Temporarily reduces fever.

Dosage and Administration

Directions

  • do not take more than directed

Adults and children: (12 years and over):

  • take 2 caplets every 4 hours
  • not to take more than 10 caplets in 24 hours

Children under 12 years: ask a doctor

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

In case of accidental 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 50567-7

When using this product do not exceed recommended dosage.

Section 50568-5

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

Section 50569-3

Ask a doctor before use if you have

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • difficulty in urination due to enlargement of the prostate gland
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough that lasts as occurs with smoking, asthma, chronic bronchitis, or emphysema
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 have ever had an allergic reaction to this product or any of its ingredients
  • 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.

Section 51727-6

Inactive ingredients

corn starch, crospovidone, FD&C yellow #6 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide

Section 51945-4

Medique® @ Home

Decorel Forte

Acetaminophen 325 mg • Pain Reliever/Fever Reducer

Dextromethorphan HBr 10 mg • Cough Suppressant

Guaifenesin 100 mg • Expectorant

Phenylephrine HCl 5 mg • Nasal Decongestant

Pull to Open

Child-Resistant Packets

*not actual size

50 Packets

(2 Caplets Per Packet)

Section 53413-1

Questions or comments? 1-800-634-7680

Section 53414-9

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

Section 55105-1

Purpose

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Section 55106-9

Active ingredients (in each caplet)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 100 mg

Phenylephrine HCl 5 mg

Section 60561-8

Other information

  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • TAMPER EVIDENT child resistant packets
  • do not use any opened or torn packets

Structured Label Content

Indications and Usage (34067-9)

Uses

Temporarily relieves these symptoms due to the common cold:

  • headache
  • nasal congestion
  • cough
  • minor aches and pains
  • sore throat
  • sinus congestion and pressure
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make cough more productive

Temporarily reduces fever.

Dosage and Administration (34068-7)

Directions

  • do not take more than directed

Adults and children: (12 years and over):

  • take 2 caplets every 4 hours
  • not to take more than 10 caplets in 24 hours

Children under 12 years: ask a doctor

Warnings and Precautions (34071-1)

Warnings

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

  • more than 4,000 mg of acetaminophen in 24 hours
  • 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:

  • blisters
  • rash
  • skin reddening

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 a doctor promptly.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

In case of accidental 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 50567-7 (50567-7)

When using this product do not exceed recommended dosage.

Section 50568-5 (50568-5)

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

Section 50569-3 (50569-3)

Ask a doctor before use if you have

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • difficulty in urination due to enlargement of the prostate gland
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough that lasts as occurs with smoking, asthma, chronic bronchitis, or emphysema
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 have ever had an allergic reaction to this product or any of its ingredients
  • 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.

Section 51727-6 (51727-6)

Inactive ingredients

corn starch, crospovidone, FD&C yellow #6 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide

Section 51945-4 (51945-4)

Medique® @ Home

Decorel Forte

Acetaminophen 325 mg • Pain Reliever/Fever Reducer

Dextromethorphan HBr 10 mg • Cough Suppressant

Guaifenesin 100 mg • Expectorant

Phenylephrine HCl 5 mg • Nasal Decongestant

Pull to Open

Child-Resistant Packets

*not actual size

50 Packets

(2 Caplets Per Packet)

Section 53413-1 (53413-1)

Questions or comments? 1-800-634-7680

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

Cough suppressant

Expectorant

Nasal decongestant

Section 55106-9 (55106-9)

Active ingredients (in each caplet)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 100 mg

Phenylephrine HCl 5 mg

Section 60561-8 (60561-8)

Other information

  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • TAMPER EVIDENT child resistant packets
  • do not use any opened or torn packets

Advanced Ingredient Data


Raw Label Data

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