SINE-EEZ- sinus decongestant tablet

Sine-EEz by

Drug Labeling and Warnings

Sine-EEz by is a Otc medication manufactured, distributed, or labeled by Cintas, ULTRAtab Laboratories, Inc., ULTRAtab Laboratories, Inc. , Ultra Seal Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Each tablet contains: Phenylephrine HCL 5mg

PURPOSE

nasal Decongestant

INDICATIONS & USAGE

Uses: temporarily relieves nasal congestion due to: common cold, hayfever or other upper respiratory allergies, stuffy nose

WARNINGS

FOR COMPLETE WARNINGS/CAUTIONS: SEE BOX

When using this product do not exceed recommended dose.

DO NOT USE

Do not use lf you are now taking a prescription monoamlne oxidase lnhibitor (MAOl) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease) or for 2 weeks after stopping MAOl drug .If you do not know if your prescription drug contains a MAOl, consult a doctor or pharmacist before taking this product.

ASK DOCTOR

Ask a doctor before use if you have: heart disease, high blood pressure, thyroid disease, diabetes, trouble urinating due to enlarged prostate gland

STOP USE

Stop use and ask a doctor if nervousness, dizziness or sleeplessness occur, symptoms do not improve within 7 days or are accompanied by fever, new symptoms occur.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN.

OVERDOSAGE

In case of overdose, get medical help or contact Poison Control Center right away.

PREGNANCY OR BREAST FEEDING

If pregnant or breastfeeding, ask a health professional before use

DOSAGE & ADMINISTRATION

DIRECTIONS: Adults: 2 tablets every 4 hours as needed. Do not exceed 6 doses in a 24 hours. Children under 12 years: ask a doctor.

OTHER SAFETY INFORMATION

Store at room temperature. Avoid excess heat and humidity.

PACKET NOT FOR INDIVIDUAL SALE

Do not use if packet is open or torn.

INACTIVE INGREDIENT

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SINE-EEZ 
sinus decongestant tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42961-333
Route of Administration	ORAL

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

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

Product Characteristics
Color	pink	Score	no score
Shape	ROUND	Size	6mm
Flavor		Imprint Code	FR4
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42961-333-02	2 in 1 PACKET; Type 0: Not a Combination Product	11/29/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	11/29/2016

Labeler - Cintas (056481716)

Registrant - ULTRAtab Laboratories, Inc. (151051757)

Establishment
Name	Address	ID/FEI	Business Operations
ULTRAtab Laboratories, Inc.		151051757	manufacture(42961-333)

Establishment
Name	Address	ID/FEI	Business Operations
Ultra Seal Corporation		085752004	pack(42961-333)