Maximum Strength Nasal Decongestant

Maximum Strength Nasal Decongestant
SPL v5
SPL
SPL Set ID 109b39e4-477e-4495-ad24-1212420375e4
Route
ORAL
Published
Effective Date 2021-12-28
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 Aluminum Lake Calcium Phosphate Fd&c Blue No. 1 Fd&c Red No. 40 Fd&c Yellow No. 6 Hypromelloses Lactose Monohydrate Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Sodium Starch Glycolate Type A Starch, Potato Stearic Acid 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 2021-12-28
Description

Phenylephrine Hydrochloride 10 mg

Purpose

Nasal decongestant

Medication Information

Purpose

Nasal decongestant

Description

Phenylephrine Hydrochloride 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

Carton

Section 42229-5

Distributed By:

Spirit Pharmaceuticals, LLC

Ronkonkoma, NY 11779

Made in India

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.

Warnings

Directions

adults & children12 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

Drug Facts

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*, *contains one or more of these ingredients

Questions Or Comments?

1-888-333-9792

Active Ingredient (in Each Tablet)

Phenylephrine Hydrochloride 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

Carton

Section 42229-5 (42229-5)

Distributed By:

Spirit Pharmaceuticals, LLC

Ronkonkoma, NY 11779

Made in India

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.

Purpose

Nasal decongestant

Warnings

Directions

adults & children12 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

Drug Facts

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*, *contains one or more of these ingredients

Questions Or Comments? (Questions or comments?)

1-888-333-9792

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

Phenylephrine Hydrochloride 10 mg

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:46.920503 · Updated: 2026-03-14T23:05:45.354656