SINU-PHEN- phenylephrine hcl tablet

Sinu-Phen by

Drug Labeling and Warnings

Sinu-Phen 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 due

to the common cold, hay fever, or other

respiratory allergies.

helps decongest nasal and sinus passages

helps to temporarily relieve stu-y nose and

sinus pressure

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:

Do not take this product if you have

any of the following:

heart disease diabetes

high blood pressure thyroid disease

or di　culty in urination due to the enlargement

of the prostate gland

When using this product: DO NOT EXCEED

RECOMMENDED DOSAGE.

Stop use and ask a doctor if:

nervousness, dizziness or sleeplessness occur

symptoms do not improve within 7 days or are

accompanied by high fever

redness or swelling occur

Drug Interaction Precaution: Do not use this product if

you are now taking prescription monoamine oxidase

inhibitor (MAOI) (certain drugs for depression,

psychiatric or emotional conditions, or Parkinson's

disease), or for 2 weeks after stopping the MAOI drug. If

you are uncertain whether your prescription drug

contains an MAOI consult a health professional before

taking this product.

DOSAGE & ADMINISTRATION

Directions:

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

 every 4 hours, not exceed 12 tablets in

24 hours. Children 12 years and under  Do not use this adult strength product.

Please consult a physician before use.

INACTIVE INGREDIENT

Inactive Ingredients:

croscarmellose sodium, D&C red #27

lake, dicalcium phosphate,

magnesium stearate, microcrystalline

cellulose, pharmaceutical glaze,

pregelatinized starch, silica, sodium

starch glycolate, stearic acid and talc.

ACTIVE INGREDIENT

ACTIVE INGREDIENT-PHENYLEPHRINE HCl 5 MG

PURPOSE

NASAL DECONGESTANT

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SINU-PHEN 
phenylephrine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69103-2536
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

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
D&C RED NO. 27 (UNII: 2LRS185U6K)
STEARIC ACID (UNII: 4ELV7Z65AP)
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SHELLAC (UNII: 46N107B71O)
STARCH, CORN (UNII: O8232NY3SJ)
TALC (UNII: 7SEV7J4R1U)

Product Characteristics
Color	white (SNOW WHITE)	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	FR21
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69103-2536-5	250 in 1 CARTON	04/03/2015
1		2 in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 69103-2536-6	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(69103-2536)

Establishment
Name	Address	ID/FEI	Business Operations
ULTRAtab Laboratories, Inc.		151051757	manufacture(69103-2536)