SINU-PHEN PLUS- phenylephrine hcl, acetaminophen tablet

Sinu-Phen Plus by

Drug Labeling and Warnings

Sinu-Phen Plus by is a Otc medication manufactured, distributed, or labeled by Provision Medical Products, Ultraseal Corporation, ULTRAtab Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INDICATIONS & USAGE

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

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health

professional before use.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN. In

case of overdose, get medical help or

contact a Poison Control Center right

away.

WARNINGS

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

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

Inactive Ingredients:

FD&C Blue #1, Microcrystalline Cellulose,

Povidone, Sodium Starch Glycolate, Starch,

Stearic Acid

ACTIVE INGREDIENT

ACTIVE INGREDIENT-ACETAMINOPHEN 500 MG, PHENYLEPHRINE HCl 5 MG

PURPOSE

PAIN RELIEVER, FEVER REDUCER, NASAL DECONGESTANT

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SINU-PHEN PLUS 
phenylephrine hcl, acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69103-2546
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
STEARIC ACID (UNII: 4ELV7Z65AP)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POVIDONE K30 (UNII: U725QWY32X)
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	blue (SKY BLUE)	Score	no score
Shape	ROUND	Size	11mm
Flavor		Imprint Code	FR2
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69103-2546-5	250 in 1 PACKAGE	04/03/2015
1		2 in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 69103-2546-6	100 in 1 CARTON	04/03/2015
2		2 in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	03/31/2015

Labeler - Provision Medical Products (036936831)

Registrant - Provision Medical Products (036936831)

Establishment
Name	Address	ID/FEI	Business Operations
Ultraseal Corporation		085752004	pack(69103-2546)

Establishment
Name	Address	ID/FEI	Business Operations
ULTRAtab Laboratories, Inc.		151051757	manufacture(69103-2546)