SINU-PHEN PLUS- phenylephrine hcl, acetaminophen tablet
Provision Medical Products
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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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
KEEP OUT OF REACH OF CHILDREN. In
case of overdose, get medical help or
contact a Poison Control Center right
away.
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
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.
SINU-PHEN PLUS
phenylephrine hcl, acetaminophen tablet |
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Labeler - Provision Medical Products (036936831) |
Registrant - Provision Medical Products (036936831) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
ULTRAtab Laboratories, Inc. | 151051757 | manufacture(69103-2546) |