SINE-EEZ- sinus decongestant tablet
Cintas Corporation

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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Sine-EEZ

Each tablet contains: Phenylephrine HCL 5mg

nasal Decongestant

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

FOR COMPLETE WARNINGS/CAUTIONS: SEE BOX

When using this product do not exceed recommended dose.

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

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.

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

If pregnant or breastfeeding, ask a health professional before use

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.

Store at room temperature. Avoid excess heat and humidity.

PACKET NOT FOR INDIVIDUAL SALE

Do not use if packet is open or torn.

Sine-Eez

PDP-01

SINE-EEZ
sinus decongestant tablet

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

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

Ingredient Name	Strength
Inactive Ingredients
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

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

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	11/29/2016	12/29/2022

Labeler - Cintas Corporation (056481716)

Registrant - Cintas Corporation (056481716)

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

Revised: 12/2022

Document Id: 63b20f2c-61e7-4922-8882-f3802f76dd8c

Set id: 225cec12-3e85-47ed-8c26-c80de15df3f6

Version: 3

Effective Time: 20221229

Cintas Corporation