non-drowsy nasal decongestant

non-drowsy nasal decongestant
SPL v3
SPL
SPL Set ID 64e2a606-3d47-f255-e053-2991aa0a519d
Route
oral
Published
Effective Date 2020-02-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
phenylephrine (10 mg)
Inactive Ingredients
cellulose, microcrystalline croscarmellose sodium stearic acid polyvinyl alcohol, unspecified fd&c yellow no. 6 fd&c red no. 40 d&c yellow no. 10 dibasic calcium phosphate dihydrate magnesium stearate polyethylene glycol 1000000 talc titanium dioxide

Identifiers & Packaging

Pill Appearance
Imprint: S71 Shape: round Color: red Size: 7 mm Score: 1
Marketing Status
otc monograph final active Since 2018-02-22

Description

Phenylephrine HCl 10mg


Medication Information

Warnings and Precautions

*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
  • diabetes
  • thyroid disease
  • trouble urinating due to an enlarged prostate gland

*When using this product do not exceed recommended dose.

*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 accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Active Ingredient

Phenylephrine HCl 10mg

Indications and Usage

* temporarily relieves sinus congestion and pressure

* temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies

Dosage and Administration

* take with a full glass of water

* swallow whole; do not crush, chew or dissolve

adults and children 12 years and over
  • 1 tablet every 4 hours
  • Do not take more than 6 tablets in 24 hours
children under 12 years

Ask a doctor

Description

Phenylephrine HCl 10mg

Section 50565-1

In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 51727-6

microcrystalline cellulose, dibasic calcium phosphate, croscarmellose sodium, stearic acid, magnesium stearate, polyvinyl alcohol, polyethylene glycol, talc, FD&C yellow# 6, FD&C red #40, titanium dioxide, D&C yellow #10

Section 51945-4

Section 55105-1

Nasal Decongestant


Structured Label Content

Warnings and Precautions (34071-1)

*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.

*Ask a doctor before use if you have-

  • heart disease
  • high blood pressure
  • diabetes
  • thyroid disease
  • trouble urinating due to an enlarged prostate gland

*When using this product do not exceed recommended dose.

*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 accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Active Ingredient (55106-9)

Phenylephrine HCl 10mg

Indications and Usage (34067-9)

* temporarily relieves sinus congestion and pressure

* temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies

Dosage and Administration (34068-7)

* take with a full glass of water

* swallow whole; do not crush, chew or dissolve

adults and children 12 years and over
  • 1 tablet every 4 hours
  • Do not take more than 6 tablets in 24 hours
children under 12 years

Ask a doctor

Section 50565-1 (50565-1)

In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 51727-6 (51727-6)

microcrystalline cellulose, dibasic calcium phosphate, croscarmellose sodium, stearic acid, magnesium stearate, polyvinyl alcohol, polyethylene glycol, talc, FD&C yellow# 6, FD&C red #40, titanium dioxide, D&C yellow #10

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Nasal Decongestant


Advanced Ingredient Data


Raw Label Data

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