Nasal Decongestant

Nasal Decongestant
SPL v4
SPL
SPL Set ID e8d038a3-ce56-46b8-a163-3339bd509ee8
Route
ORAL
Published
Effective Date 2022-11-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Phenylephrine (10 mg)
Inactive Ingredients
Carnauba Wax Silicon Dioxide Croscarmellose Sodium D&c Yellow No. 10 Calcium Phenoxide Fd&c Blue No. 1 Fd&c Red No. 40 Fd&c Yellow No. 6 Hypromelloses Lactose, Unspecified Form Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Sodium Starch Glycolate Type A Corn Starch, Potato Stearic Acid Talc Titanium Dihydride

Identifiers & Packaging

Pill Appearance
Imprint: 272;S08;T234 Shape: round Color: red Size: 8 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-11-15

Description

Phenylephrine HCl 10 mg

Purpose

Nasal decongestant


Medication Information

Purpose

Nasal decongestant

Description

Phenylephrine HCl 10 mg

Uses

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

Warnings

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

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.

Drug Facts

Distributed By:

Cabinet Health P.B.C.

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

Principal Display Panel

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)

Active Ingredient (in Each Tablet)

Phenylephrine HCl 10 mg

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


Structured Label Content

Uses

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

Purpose

Nasal decongestant

Warnings

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

Do Not Use (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.

Drug Facts

Distributed By: (Distributed by:)

Cabinet Health P.B.C.

Other Information (Other information)

• store between 20-25°C (68-77°F)

Inactive Ingredients (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? (Questions or comments?)

1-888-333-9792

Principal Display Panel

Stop Use and Ask A Doctor If (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, (If pregnant or breast-feeding,)

ask a health professional before use.

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)

Active Ingredient (in Each Tablet) (Active Ingredient (in each tablet))

Phenylephrine HCl 10 mg

Ask A Doctor Before Use If You Have (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 (When using this product do not exceed recommended dose)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)