Sinu-Phen Plus (phenylephrine hydrochloride 5 mg acetaminophen 500 mg) Dailymed

Indications & Usage Section

UseS  TEMPORARILY

• relieves nasal congestion associated with sinusitis

• relieves nasal congestion due to the common cold, hay fever or

other respiratory allergies

• relieves sinus congestion and pressure, helps decongest sinus

openings and passages

• restores free breathing

temporarily relieves minor aches, pains and fever associated with:

• headache

• common cold

• toothache

• backache

• muscular aches

• menstrual cramps

Otc - Pregnancy Or Breast Feeding Section

If pregnant or breast-feeding, ask a health

professional before use.

Otc - Keep Out Of Reach Of Children Section

KEEP OUT OF REACH OF CHILDREN. In

case of overdose, get medical help or

contact a Poison Control Center right

away.

Warnings Section

Warnings:

Liver Warning:

This product contains acetaminophen. Severe

liver damage may occur if you take:

• more than 8 tablets in 24 hours

• with other drugs containing acetaminophen (prescription or

nonprescription). Ask a doctor or pharmacist before using with

other drugs if you are not sure.

• 3 or more alcoholic drinks every day while using this product

Do not:

• use with any other product containing

aceteminophen this will provide more than the recommended

dose (overdose) of acetaminophen and could cause serious health

concerns.

• use more than the recommended dose

• for more than 10 days for pain unless directed by a doctor

• for more than 3 days for fever unless directed by a doctor

• when using this product do not exceed recommended dose

• if you are now taking a prescription monoamine oxidase

inhibitor (MAOI) (certain drugs for depression, psychiatric or

emotional conditions, or Parkingson’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

• pain or fever persists or gets worse

• 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

Dosage & Administration Section

Directions:

Adults and children 12 years of age and older take 2 tablets every

4-6 hours, as needed, not to exceed 8 tablets in 24 hrs as directed

by a doctor.

Children under 12 years Consult a doctor.

Inactive Ingredient Section

Inactive Ingredients:

FD&C Blue #1, Microcrystalline Cellulose,

Povidone, Sodium Starch Glycolate, Starch,

Stearic Acid

Otc - Active Ingredient Section

ACTIVE INGREDIENT-ACETAMINOPHEN 500 MG, PHENYLEPHRINE HCl 5 MG

Otc - Purpose Section

PAIN RELIEVER, FEVER REDUCER, NASAL DECONGESTANT

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