NDC 68210-0118 Assured Maximum Strength Nasal Decongestant

Phenylephrine Hcl

NDC Product Code 68210-0118

NDC Code: 68210-0118

Proprietary Name: Assured Maximum Strength Nasal Decongestant What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Phenylephrine Hcl What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Product Characteristics

Color(s):
RED (C48326)
Shape: CAPSULE (C48336)
Size(s):
8 MM
Imprint(s):
T234
Score: 1

NDC Code Structure

  • 68210 - Spirit Pharmaceuticals Llc
    • 68210-0118 - Assured Maximum Strength Nasal Decongestant

NDC 68210-0118-3

Package Description: 1 BLISTER PACK in 1 CARTON > 24 TABLET in 1 BLISTER PACK

NDC Product Information

Assured Maximum Strength Nasal Decongestant with NDC 68210-0118 is a a human over the counter drug product labeled by Spirit Pharmaceuticals Llc. The generic name of Assured Maximum Strength Nasal Decongestant is phenylephrine hcl. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Spirit Pharmaceuticals Llc

Dosage Form: Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Assured Maximum Strength Nasal Decongestant Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • PHENYLEPHRINE HYDROCHLORIDE 10 mg/1

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • 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)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Spirit Pharmaceuticals Llc
Labeler Code: 68210
FDA Application Number: part341 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 02-26-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Assured Maximum Strength Nasal Decongestant Product Label Images

Assured Maximum Strength Nasal Decongestant Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Other

Drug Facts

Drug Facts (continued)

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

Otc - When Using

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

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

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

Croscarmellose sodium, FD&C red #40 aluminum lake, FD&C yellow


#6 aluminum lake, hypromellose, lactose, magnesium stearate,


microcrystalline cellulose, polyethylene glycol, silicon dioxide,


titanium dioxide

Otc - Questions

Questions or comments? 1-888-333-9792

* Please review the disclaimer below.

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