MAXIMUM STRENGTH NASAL DECONGESTANT- phenylephrine hydrochloride tablet, coated

Maximum Strength Nasal Decongestant by

Drug Labeling and Warnings

Maximum Strength Nasal Decongestant by is a Otc medication manufactured, distributed, or labeled by Spirit Pharmaceuticals LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient (in each tablet)

Phenylephrine Hydrochloride 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 & children12 years & 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 20-25°C (68-77°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, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate*, starch*, stearic acid*, talc*, *contains one or more of these ingredients

Questions or comments?

1-888-333-9792

SPL UNCLASSIFIED SECTION

Distributed By:
Spirit Pharmaceuticals, LLC
Ronkonkoma, NY 11779

Made in India

Carton

INGREDIENTS AND APPEARANCE

MAXIMUM STRENGTH NASAL DECONGESTANT 
phenylephrine hydrochloride tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68210-5011
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
CARNAUBA WAX (UNII: R12CBM0EIZ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6)
CALCIUM PHOSPHATE (UNII: 97Z1WI3NDX)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYPROMELLOSES (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)
STARCH, POTATO (UNII: 8I089SAH3T)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	red	Score	no score
Shape	ROUND (biconvex)	Size	7mm
Flavor		Imprint Code	S08
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68210-5011-7	3 in 1 CARTON	02/10/2023
1		24 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	02/10/2023

Labeler - Spirit Pharmaceuticals LLC (179621011)