Phenylephrine HCl Maximum Strength: Package Insert and Label Information

PHENYLEPHRINE HCL MAXIMUM STRENGTH- phenylephrine hydrochloride tablet, film coated
A-S Medication Solutions

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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
  • 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
  • diabetes
  • thyroid disease
  • high blood pressure
  • difficulty in urination due to enlargement of the prostate gland

When using this product

do not exceed recommended dosage.

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur
  • symptoms do not improve within 7 days or occur with 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 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

  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • see end flap for expiration date and lot number

Inactive ingredients

croscarmellose sodium, dextrose monohydrate, dibasic calcium phosphate dihydrate, FD&C red #40, lecithin, magnesium stearate, maltodextrin, microcrystalline cellulose, silicon dioxide, sodium carboxymethylcellulose, sodium citrate dihydrate, titanium dioxide

Questions or comments?

1-800-645-2158

HOW SUPPLIED

Product: 50090-5606

NDC: 50090-5606-0 18 TABLET, FILM COATED in a BLISTER PACK / 2 in a CARTON

PHENYLEPHRINE HCL MAXIMUM STRENGTH

Label ImageLabel Image
PHENYLEPHRINE HCL MAXIMUM STRENGTH
phenylephrine hcl tablet, film coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50090-5606(NDC:0536-1291)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 10 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
DEXTROSE MONOHYDRATE
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
FD&C RED NO. 40
LECITHIN, SOYBEAN
MAGNESIUM STEARATE
MALTODEXTRIN
MICROCRYSTALLINE CELLULOSE
SILICON DIOXIDE
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM
TRISODIUM CITRATE DIHYDRATE
TITANIUM DIOXIDE
Product Characteristics
Color RED Score no score
Shape ROUND Size 7mm
Flavor Imprint Code 44;453
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50090-5606-0 2 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 18 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (50090-5606-0)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part341 04/09/2020
Labeler — A-S Medication Solutions (830016429)
Establishment
Name Address ID/FEI Operations
A-S Medication Solutions 830016429 RELABEL (50090-5606)

Revised: 09/2021 A-S Medication Solutions

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