NASAL AND SINUS DECONGESTANT tablet

Nasal and Sinus Decongestant by

Drug Labeling and Warnings

Nasal and Sinus Decongestant by is a Otc medication manufactured, distributed, or labeled by Redicare LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient (in each tablet)........................................................ Purpose

Phenylephrine HCI 5 mg.......................................................................................................Decongestant

Uses:

Temporarily: ■ relieves nasal congestion associated with sinusitis ■ relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies ■ relieves sinus congestion and pressure, helps decongest sinus opening and passages ■ restores free breathing

Warnings:

Do not use:

■ more than recommended dose ■ if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping MAOI drug. If you do not know if your prescription drug contains a MAOI, consult a doctor or pharmacist before taking this product.

Stop use and ask a doctor if

■ symptoms do not improve ■ 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

If pregnant or breast-feeding a baby,

ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN.

In a case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions:

Adults and children 12 years of age and older: Take 2 tablets every 4 hours as needed, do not exceed 8 tablets in 24 hours, or as directed by a doctor.
Children under 12 years: consult a doctor

Other Information:

■ Tamper Evident. Do not use if packet is torn, cut or opened ■ Store at controlled room temperature 15˚ to 30˚C (59˚ to 86˚F) ■ Avoid excessive heat and humidity

Inactive Ingredients:

corsscarmellose sodium, D&C Red #28, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, povidone, silicon dioxide, sodium starch glycolate, starch, stearic acid

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

NASAL AND SINUS DECONGESTANT 
nasal and sinus decongestant tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71105-333
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)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POVIDONE (UNII: FZ989GH94E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
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: 71105-333-68	100 in 1 CARTON; Type 0: Not a Combination Product	10/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	02/01/2017

Labeler - Redicare LLC (800149346)

Establishment
Name	Address	ID/FEI	Business Operations
Redicare LLC		800149346	repack(71105-333)