SPL v3
SPL
SPL Set ID 7046c016-8837-4cd7-b358-aa3a18a3289b
Route
ORAL
Published
Effective Date 2019-09-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Phenylephrine (5 1)
Inactive Ingredients
Croscarmellose Sodium D&c Red No. 27 Aluminum Lake Calcium Phosphate, Dibasic, Dihydrate Magnesium Stearate Cellulose, Microcrystalline Silicon Dioxide Starch, Corn Stearic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2015-04-09

Description

ACTIVE INGREDIENT (IN EACH TABLET)-  Phenylephrine HCl 5 mg


Medication Information

Warnings and Precautions

Warnings:

Do not use: more than the recommended dose

• 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 MAOI drug. If you do not know if your prescription drug contains an MAOI, consult a doctor or pharmacist before taking this product.

Stop use and ask a doctor if:

• symptoms do not improve

• new symptoms occur

• redness or swelling is present

• nervousness, dizziness or sleeplessness occur

• symptoms do not improve within 7 days or are accompanied by fever

Ask a doctor before use if you have: • heart disease • high blood pressure • thyroid disease • diabetes • difficulty in urination due to enlargement of the prostate gland

Indications and Usage

Uses: temporarily: • relieves nasal congestion associated with sinusitis •relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies • relieves sinus congestion and pressure, helps decongest sinus openings and passages • restores freer breathing through the nose

Dosage and Administration

Directions:

Adults and children 12 years of age and older:  Take 2 tablets every 4 to 6 hours or as needed, do not exceed 8 tablets in 24 hours, or as directed by a doctor.

Children under 12 years: Consult a doctor.

Description

ACTIVE INGREDIENT (IN EACH TABLET)-  Phenylephrine HCl 5 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. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 51727-6

Inactive Ingredients: crosscarmellose sodium, D&C Red #27 lake, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, silicon dioxide, starch, stearic acid

Section 51945-4

Section 53414-9

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

Section 55105-1

Nasal Decongestant

Section 55106-9

ACTIVE INGREDIENT (IN EACH TABLET)-  Phenylephrine HCl 5 mg


Structured Label Content

Indications and Usage (34067-9)

Uses: temporarily: • relieves nasal congestion associated with sinusitis •relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies • relieves sinus congestion and pressure, helps decongest sinus openings and passages • restores freer breathing through the nose

Dosage and Administration (34068-7)

Directions:

Adults and children 12 years of age and older:  Take 2 tablets every 4 to 6 hours or as needed, do not exceed 8 tablets in 24 hours, or as directed by a doctor.

Children under 12 years: Consult a doctor.

Warnings and Precautions (34071-1)

Warnings:

Do not use: more than the recommended dose

• 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 MAOI drug. If you do not know if your prescription drug contains an MAOI, consult a doctor or pharmacist before taking this product.

Stop use and ask a doctor if:

• symptoms do not improve

• new symptoms occur

• redness or swelling is present

• nervousness, dizziness or sleeplessness occur

• symptoms do not improve within 7 days or are accompanied by fever

Ask a doctor before use if you have: • heart disease • high blood pressure • thyroid disease • diabetes • difficulty in urination due to enlargement of the prostate gland

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. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 51727-6 (51727-6)

Inactive Ingredients: crosscarmellose sodium, D&C Red #27 lake, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, silicon dioxide, starch, stearic acid

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Nasal Decongestant

Section 55106-9 (55106-9)

ACTIVE INGREDIENT (IN EACH TABLET)-  Phenylephrine HCl 5 mg


Advanced Ingredient Data


Raw Label Data

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