Drug Facts

Active ingredient (in each tablet)

Phenylephrine HCl 10 mg

Purpose

Nasal decongestant

Uses

■ temporarily relieves sinus congestion and pressure
■ temporarily relieves nasal congestion due to the common cold, hay
fever or other upper respiratory allergies

Warnings

Do not use 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 the
MAOI drug. If you do not know if your prescription drug contains an
MAOI, ask 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 an enlarged prostate gland

When using this product do not exceed recommended dose

Stop use and ask a doctor if

■ nervousness, dizziness, or sleeplessness occur
■ symptoms do not improve within 7 days or occur with a fever

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or
contact a Poison Control Center right away. (1-800-222-1222)

Directions


adults and children 12 years and over	■ take 1 tablet every 4 hours ■ do not take more than 6 tablets in 24 hours
children under 12 years	ask a doctor

Other information

store between 20° to 25°C (68° to 77°F)

Inactive ingredients

carnauba wax*, colloidal silicon dioxide*, croscarmellose sodium*, D&C yellow#10 aluminum lake*, dicalcium phosphate*, FD&C Blue#1*, FD&C Red #40 , FD&C Yellow#6*, hypromellose, lactose*, magnesium stearate, microcrytalline cellulose, polyethylene glycol, sodium starch glycolate*, starch*, stearic acid*, talc*, titanium dioxide
*contains one or more of these ingredients

Questions or comments? 1-888-333-9792

PRINCIPAL DISPLAY PANEL

Maximum Strength

Nasal Decongestant
Phenylephrine HCl 10 mg - Nasal Decongestant

Relieves:
• Nasal & Sinus Congestion • Sinus Pressure

24 Tablets

Carton

NASAL DECONGESTANT
phenylephrine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68210-4142
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg

Ingredient Name	Strength
Inactive Ingredients
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CARNAUBA WAX (UNII: R12CBM0EIZ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)
MAGNESIUM STEARATE (UNII: 70097M6I30)

Product Characteristics
Color	red	Score	no score
Shape	CAPSULE	Size	8mm
Flavor		Imprint Code	272;S08;T234
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:68210-4142-2	1 in 1 CARTON	04/28/2021
1		24 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M012	04/28/2021

Labeler - Spirit Pharmaceuticals LLC (179621011)

Nasal Decongestant Tablets