sinus congestion relief

sinus congestion relief
SPL v5
SPL
SPL Set ID b96872da-6c32-4968-8385-b7e7b3fea0e2
Route
oral
Published
Effective Date 2022-05-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
phenylephrine (10 mg)
Inactive Ingredients
silicon dioxide d&c yellow no. 10 aluminum lake fd&c blue no. 1 fd&c red no. 40 hypromelloses magnesium stearate cellulose, microcrystalline polyethylene glycol, unspecified starch, potato sodium starch glycolate type a potato talc titanium dioxide

Identifiers & Packaging

Pill Appearance
Imprint: S08 Shape: round Color: red Size: 7 mm Score: 1
Marketing Status
otc monograph drug active Since 2022-05-30

Purpose

Nasal decongestant

Description

Phenylephrine HCl 10 mg


Medication Information

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

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 Information

• store between 20-25°C (68-77°F)

Inactive Ingredients

colloidal silicon dioxide, D&C yellow#10 aluminum lake, FD&C Blue#1, FD&C Red #40, hypromellose, magnesium stearate, microcrytalline cellulose, polyethylene glycol, starch, sodium starch glycolate, talc, titanium dioxide

Description

Phenylephrine HCl 10 mg

Principal Display Panel

Compare to active

ingredient in Sudafed PE®

Sinus Congestion†

NDC 82501-1577-1

Good now

Sinus Congestion Relief PE

Phenylephrine HCl Tablets, 10 mg

24 TABLETS

Nasal Decongestant

Relief of

Nasal & Sinus Congestion

Sinus Pressure

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 50566-9

Stop use and ask a doctor if • nervousness, dizziness, or sleeplessness occur • symptoms do not improve within 7 days or occur with a fever

Section 50567-7

When using this product do not exceed recommended dose

Section 50569-3

Ask a doctor before use if you have • heart disease • high blood pressure • thyroid disease • diabetes

• trouble urinating due to an enlarged prostate gland

Section 50570-1

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.

Section 53414-9

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

Drug Facts

Questions Or Comments?

1-888-333-9792

Active Ingredient (in Each Tablet)

Phenylephrine HCl 10 mg


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

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 Information (Other information)

• store between 20-25°C (68-77°F)

Inactive Ingredients (Inactive ingredients)

colloidal silicon dioxide, D&C yellow#10 aluminum lake, FD&C Blue#1, FD&C Red #40, hypromellose, magnesium stearate, microcrytalline cellulose, polyethylene glycol, starch, sodium starch glycolate, talc, titanium dioxide

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Compare to active

ingredient in Sudafed PE®

Sinus Congestion†

NDC 82501-1577-1

Good now

Sinus Congestion Relief PE

Phenylephrine HCl Tablets, 10 mg

24 TABLETS

Nasal Decongestant

Relief of

Nasal & Sinus Congestion

Sinus Pressure

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 50566-9 (50566-9)

Stop use and ask a doctor if • nervousness, dizziness, or sleeplessness occur • symptoms do not improve within 7 days or occur with a fever

Section 50567-7 (50567-7)

When using this product do not exceed recommended dose

Section 50569-3 (50569-3)

Ask a doctor before use if you have • heart disease • high blood pressure • thyroid disease • diabetes

• trouble urinating due to an enlarged prostate gland

Section 50570-1 (50570-1)

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.

Section 53414-9 (53414-9)

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

Drug Facts

Questions Or Comments? (Questions or comments?)

1-888-333-9792

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

Phenylephrine HCl 10 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)