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Sinu-Phen Plus

Dosage form: tablet
Ingredients: PHENYLEPHRINE HYDROCHLORIDE 5mg, ACETAMINOPHEN 500mg
Labeler: Provision Medical Products
NDC Code: 69103-2546

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.

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

If pregnant or breast-feeding, ask a health

professional before use.

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.

Inactive Ingredients:

FD&C Blue #1, Microcrystalline Cellulose,

Povidone, Sodium Starch Glycolate, Starch,

Stearic Acid

ACTIVE INGREDIENT-ACETAMINOPHEN 500 MG, PHENYLEPHRINE HCl 5 MG

PAIN RELIEVER, FEVER REDUCER, NASAL DECONGESTANT

SINU-PHEN PLUS 
phenylephrine hcl, acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69103-2546
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
SODIUM STARCH GLYCOLATE TYPE A CORN 
FD&C BLUE NO. 1 
STEARIC ACID 
CELLULOSE, MICROCRYSTALLINE 
POVIDONE K30 
STARCH, PREGELATINIZED CORN 
Product Characteristics
Colorblue (SKY BLUE) Scoreno score
ShapeROUNDSize11mm
FlavorImprint CodeFR2
Contains    
Packaging
#Item CodePackage Description
1NDC:69103-2546-5250 PACKET in 1 PACKAGE
12 TABLET in 1 PACKET
2NDC:69103-2546-6100 PACKET in 1 CARTON
22 TABLET in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/31/2015
Labeler - Provision Medical Products (036936831)
Registrant - Provision Medical Products (036936831)
Establishment
NameAddressID/FEIOperations
Ultraseal Corporation085752004pack(69103-2546)
Establishment
NameAddressID/FEIOperations
ULTRAtab Laboratories, Inc.151051757manufacture(69103-2546)

 
Provision Medical Products

Medically reviewed on Apr 3, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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