Nasal Decongestant Tablets

Nasal Decongestant Tablets
SPL v7
SPL
SPL Set ID c10b5323-b36e-a991-e053-2a95a90a5484
Route
ORAL
Published
Effective Date 2021-04-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Phenylephrine (10 mg)
Inactive Ingredients
Microcrystalline Cellulose Polyethylene Glycol 400 Sodium Starch Glycolate Type A Corn Starch, Corn Stearic Acid Talc Titanium Dioxide Carnauba Wax Silicon Dioxide Croscarmellose Sodium D&c Yellow No. 10 Aluminum Lake Anhydrous Dibasic Calcium Phosphate Fd&c Blue No. 1 Fd&c Red No. 40 Fd&c Yellow No. 6 Hypromellose, Unspecified Lactose, Unspecified Form Magnesium Stearate

Identifiers & Packaging

Pill Appearance
Imprint: 272;S08;T234 Shape: capsule Color: red Size: 8 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-04-28

Description

Drug Facts

Purpose

Nasal decongestant


Medication Information

Purpose

Nasal decongestant

Description

Drug Facts

Uses

■ temporarily relieves sinus congestion and pressure

■ temporarily relieves nasal congestion due to the common cold, hay

fever or other upper respiratory allergies

Section 42229-5

Drug Facts

Section 50565-1

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)

Section 50567-7

When using this product do not exceed recommended dose

Section 53413-1

Questions or comments? 1-888-333-9792

Section 53414-9

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

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.

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

Principal Display Panel

Maximum Strength



Nasal Decongestant

Phenylephrine HCl 10 mg - Nasal Decongestant

Relieves:

• Nasal & Sinus Congestion • Sinus Pressure

24 Tablets

Stop Use and Ask A Doctor If

■ nervousness, dizziness, or sleeplessness occur

■ symptoms do not improve within 7 days or occur with a fever

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


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

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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)

Section 50567-7 (50567-7)

When using this product do not exceed recommended dose

Section 53413-1 (53413-1)

Questions or comments? 1-888-333-9792

Section 53414-9 (53414-9)

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

Purpose

Nasal decongestant

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.

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 (Other information)

store between 20° to 25°C (68° to 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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Maximum Strength



Nasal Decongestant

Phenylephrine HCl 10 mg - Nasal Decongestant

Relieves:

• Nasal & Sinus Congestion • Sinus Pressure

24 Tablets

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

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)