Nasal Decongestant

Set ID
51d273c9-804e-4001-844b-ffa15e57265a
Manufacturer
Spirit Pharmaceuticals LLC
Effective date
2024-12-13
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:43:12

Key Label Information

Active Ingredients And Purpose

Active Ingredient (in each tablet)

Phenylephrine HCl 10 mg

Purpose

Nasal decongestant

Uses

Uses

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

Warnings

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

Stop use and ask a doctor if

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

Directions And Dosage

Directions

adults & children 12 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 Label Information

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, 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

Pouch

Products

NDC Codes

Ingredients

NameUNIIKind
CARNAUBA WAXR12CBM0EIZIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
D&C YELLOW NO. 1035SW5USQ3GIACT
CALCIUM PHENOXIDEDRU8G42RVEIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
HYPROMELLOSES3NXW29V3WOIACT
LACTOSE, UNSPECIFIED FORMJ2B2A4N98GIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
SODIUM STARCH GLYCOLATE TYPE A CORNAG9B65PV6BIACT
STARCH, POTATO8I089SAH3TIACT
STEARIC ACID4ELV7Z65APIACT
TALC7SEV7J4R1UIACT
TITANIUM DIHYDRIDE8930U91840IACT
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIM

Complete SPL Sections

Drug Facts

SPL UNCLASSIFIED SECTION

Active Ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Phenylephrine HCl 10 mg

Purpose

OTC - PURPOSE SECTION

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR SECTION

• 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

OTC - WHEN USING SECTION

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

adults & children 12 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

STORAGE AND HANDLING SECTION

• store between 20-25°C (68-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

1-888-333-9792

Distributed by:

SPL UNCLASSIFIED SECTION

Cabinet Health P.B.C.

Pouch

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Source Document

Official SPL XML cached by FDA.report · DailyMed PDF

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Legacy File Index

FolderFileDate
otc292ac599-901c-1ce0-e063-6294a90a1fb1.xml2024-12-15
otc0befe1f8-169f-2256-e063-6394a90a6680.xml2023-12-08
otceecb6fbb-cbdf-53fd-e053-2a95a90aedd3.xml2022-12-02
otcd16333de-76df-ae53-e053-2995a90a3cd4.xml2021-11-23
otcNasal Decongestant.jpg2021-11-23