yyba (as pld) - welmate - nasal decongestant pe tablets, 10 mg (73581-204)

yyba (as pld) - welmate - nasal decongestant pe tablets, 10 mg (73581-204)
SPL v6
SPL
SPL Set ID 05824fc4-ef3f-4ebb-b601-252f76ad60ef
Route
oral
Published
Effective Date 2021-08-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
phenylephrine (25 mg)
Inactive Ingredients
croscarmellose sodium dextrose monohydrate dibasic calcium phosphate dihydrate fd&c red no. 40 lecithin, sunflower magnesium stearate maltodextrin microcrystalline cellulose silicon dioxide sodium carboxymethyl .beta.-glucan (ds 0.65-0.85) trisodium citrate dihydrate titanium dioxide

Identifiers & Packaging

Pill Appearance
Imprint: 44;453 Shape: round Color: red Size: 8 mm Score: 1
Marketing Status
otc monograph drug active Since 2021-08-03

Purpose

Nasal decongestant

Description

Phenylephrine HCL 10 mg


Medication Information

Warnings

Do not useif you are taking a prescription monoamine oxidase inhibitor (MA0l)(certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MA0l drug. If you do not know if your prescription drug contains an MA0l, 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,as a health professional before use. 

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

Nasal decongestant

Directions
  • adults and children 12 years and older:

take 1 tablet 4 hours. Do not take more than 6 tablets in 24 hours

  • children under 12 years:ask a doctor
Other Information
  • store between 20° and 25°C (68° and 77°F)
  • protect from excessive moisture
Inactive Ingredients

croscarmellose sodium, dextrose monohydrate, dicalcium phosphate dihydrate, FD&C red #40. lecithin, magnesium stearate, maltrodextrin, microcrystalline cellulose, silicon dioxide, sodium carboxymethylcellulose, sodium citrate dihydrate, titanium dioxide

Description

Phenylephrine HCL 10 mg

Questions?

call toll-free 1-866-933-6337

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 51945-4

Active Ingredient (in Each Tablet)

Phenylephrine HCL 10 mg


Structured Label Content

Warnings

Do not useif you are taking a prescription monoamine oxidase inhibitor (MA0l)(certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MA0l drug. If you do not know if your prescription drug contains an MA0l, 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,as a health professional before use. 

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

Nasal decongestant

Directions
  • adults and children 12 years and older:

take 1 tablet 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° and 25°C (68° and 77°F)
  • protect from excessive moisture
Inactive Ingredients (Inactive ingredients)

croscarmellose sodium, dextrose monohydrate, dicalcium phosphate dihydrate, FD&C red #40. lecithin, magnesium stearate, maltrodextrin, microcrystalline cellulose, silicon dioxide, sodium carboxymethylcellulose, sodium citrate dihydrate, titanium dioxide

Questions?

call toll-free 1-866-933-6337

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 51945-4 (51945-4)

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

Phenylephrine HCL 10 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)