Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 848c680c-22c4-4b43-bc3a-21ff72e88888
Route
ORAL
Published
Effective Date 2019-04-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pseudoephedrine (30 mg) Guaifenesin (200 mg)
Inactive Ingredients
Povidone K30 Stearic Acid Cellulose, Microcrystalline Sodium Starch Glycolate Type A Potato Maltodextrin

Identifiers & Packaging

Pill Appearance
Imprint: EP230 Shape: round Color: white Size: 9 mm Score: 1
Marketing Status
OTC MONOGRAPH FINAL Active Since 2019-03-15

Description

Active Ingredient(In Each Tablet): Pseudoephedrine HCl 30 mg, Guaifenesin 200 mg


Medication Information

Warnings and Precautions

Do not use: • 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: • heart disease • high blood pressure • thyroid disease • diabetes • trouble urinating due to an enlarged prostate gland • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema • a cough accompanied by excessive phlegm (mucus)

When using this product • do not use more than directed • intentional abuse of this product can be harmful or fatal

Stop use and ask a doctor if: • you get nervous dizzy or sleepless • cough lasts more than 7 days, comes back, or occurs with fever, rash or headache that lasts. These could be signs of a serious condition. • symptoms do not get better within 7 days or occur with a fever

Indications and Usage

• temporarily relieves nasal congestion due to the common cold • promotes nasal and/or sinus drainage • temporarily relieves sinus congestion and pressure • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

Dosage and Administration

• adults and children 12 years of age and over: take 2 tablets every 4 to 6 hours; do not exceed 8 tablets in 24 hours • children under 12 years of age: ask a doctor

Description

Active Ingredient(In Each Tablet): Pseudoephedrine HCl 30 mg, Guaifenesin 200 mg

Section 50565-1

Keep out of reach of children.  In case of overdose, get medical help or contact a Poison Control Center right away.

Section 51727-6

Inactive Ingredients: Maltodextrin, Microcrystalline Cellulose, Povidone, Sodium Starch Glycolate, Stearic Acid

Section 51945-4

Section 53414-9

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

Section 55105-1

Purposes - Nassal Decongestant, Expectorant

Section 55106-9

Active Ingredient(In Each Tablet): Pseudoephedrine HCl 30 mg, Guaifenesin 200 mg


Structured Label Content

Indications and Usage (34067-9)

• temporarily relieves nasal congestion due to the common cold • promotes nasal and/or sinus drainage • temporarily relieves sinus congestion and pressure • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

Dosage and Administration (34068-7)

• adults and children 12 years of age and over: take 2 tablets every 4 to 6 hours; do not exceed 8 tablets in 24 hours • children under 12 years of age: ask a doctor

Warnings and Precautions (34071-1)

Do not use: • 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: • heart disease • high blood pressure • thyroid disease • diabetes • trouble urinating due to an enlarged prostate gland • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema • a cough accompanied by excessive phlegm (mucus)

When using this product • do not use more than directed • intentional abuse of this product can be harmful or fatal

Stop use and ask a doctor if: • you get nervous dizzy or sleepless • cough lasts more than 7 days, comes back, or occurs with fever, rash or headache that lasts. These could be signs of a serious condition. • symptoms do not get better within 7 days or occur with a fever

Section 50565-1 (50565-1)

Keep out of reach of children.  In case of overdose, get medical help or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

Inactive Ingredients: Maltodextrin, Microcrystalline Cellulose, Povidone, Sodium Starch Glycolate, Stearic Acid

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purposes - Nassal Decongestant, Expectorant

Section 55106-9 (55106-9)

Active Ingredient(In Each Tablet): Pseudoephedrine HCl 30 mg, Guaifenesin 200 mg


Advanced Ingredient Data


Raw Label Data

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