Phenylephrine Hydrochloride description, usages, side effects, indications, overdosage, supplying and lots more!

Phenylephrine Hydrochloride

AAA Pharmaceutical, Inc.

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
Phenylephrine HCl Tablets

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient (in each tablet)

Phenylephrine HCl 10 mg

Purpose

Nasal decongestant

Uses

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

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.

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 use more than directed

Stop use and ask a doctor if

  • you get nervous, dizzy, or sleepless
  • symptoms do not improve within 7 days or are accompanied by 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.

Directions

  • adults and children 12 years of age and over: take 1 tablet every 4 hours; do not take more than 6 tablets in 24 hours
  • children under 12 years of age: ask a doctor

Other information

  • store at 15°-25°C (59°-77°F) in a dry place
  • retain carton for complete product information

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, D&C red #27, FD&C red #40, FD&C yellow #6, hypromellose, lactose anhydrous, magnesium stearate, polyethylene glycol, stearic acid, titanium dioxide

Distributed by:
AAA Pharmaceutical, Inc.
681 Main Street
Lumberton, NJ 08048

PRINCIPAL DISPLAY PANEL - 36 Tablet Blister Pack Carton

RESTORE u

NDC 57344-131-03

COMPARE TO THE ACTIVE
INGREDIENT IN SUDAFED PE®
NASAL DECONGESTANT

MAXIMUM
STRENGTH

NON-DROWSY

Nasal Decongestant PE

Phenylephrine HCl

Relieves: • Nasal & Sinus Congestion • Sinus Pressure

36 TABLETS - 10 mg each

PRINCIPAL DISPLAY PANEL - 36 Tablet Blister Pack Carton

Phenylephrine Hydrochloride

PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:57344-131
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Phenylephrine Hydrochloride PHENYLEPHRINE 10 mg

Inactive Ingredients

Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
D&C RED NO. 27
FD&C RED NO. 40
FD&C YELLOW NO. 6
HYPROMELLOSES
ANHYDROUS LACTOSE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOLS
STEARIC ACID
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
RED 7 mm A;131 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 18 in 1 BLISTER PACK
2 18 in 1 BLISTER PACK
3 18 in 1 BLISTER PACK
4 150 in 1 BOTTLE, PLASTIC
5 NDC:57344-131-05 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2012-12-22


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Be sure to consult your doctor before taking any medication!
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