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

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Pyrilamine-Phenylephrine

Acella Pharmaceuticals, LLC

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient

Purpose

Active Ingredients (in each 5 mL) Purpose
Pyrilamine Maleate 16 mg Antihistamine
Phenylephrine HCl 5 mg Nasal Decongestant

Pyrilamine-Phenylephrine Uses

  • temporary relief of
  • sneezing
  • itchy nose or throat
  • runny nose
  • itchy, watery eyes due to hay fever or upper respiratory allergies
  • nasal and sinus congestion due to the common cold.

Warnings

  • may cause excitability, especially in children
  • do not use if you are 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 our prescription drug contains an MAOI, ask a doctor or pharmacist before you take this product.

Ask a doctor before use if you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • glaucoma
  • a breathing problem such as asthma, chronic bronchitis or emphysema
  • trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you have

  • you or your child are taking sedatives or tranquilizers

When using this product

  • do not exceed recommended dosage
  • drowsiness may occur
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

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

If pregnant or breastfeeding, 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. 1-800-222-1222

Directions

  • take every 6 hours.
  • Do not take more than 4 doses in 24 hours or as directed by a doctor.
Age Dose
Adults and children 12 years of age and older 1 to 2 teaspoonfuls
Children 6 to under 12 years of age 1 teaspoonful
Children under 6 years of age As directed by a physician

Pyrilamine-Phenylephrine Other information

  • store at 20 - 25ºC (68 - 77ºF), excursions permitted between 15 - 30ºC (between 59 - 86ºF)
  • Tamper Evident: Do not use if seal is broken or missing.

Inactive ingredients

Artificial Grape Flavor, Citric Acid, FD&C Blue #1, FD&C Red #40, Glycerin, Hydrochloric Acid, Magnesium Aluminum Silicate, Methylparaben, Potassium Sorbate, Purified Water, Sodium Benzoate, Sodium Citrate Dihydrate,Sodium Saccharin, Sucrose and Xanthan Gum.

Questions or comments

1-800-541-4802

Questions or comments

Manufactured for:
Acella Pharmaceuticals, LLC
Alpharetta, GA 30009

Rev. 0812

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

NDC 42192-521-16

Pyrilamine-
Phenylephrine
Suspension

Antihistamine
Nasal Decongestant

Grape Bubblegum Flavor

SHAKE WELL

16 fl oz (473 mL)

Acella
PHARMACEUTICALS, LLC

Pyrilamine-Phenylephrine

Pyrilamine-Phenylephrine

Pyrilamine Maleate and Phenylephrine Hydrochloride LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:42192-521
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
PYRILAMINE MALEATE PYRILAMINE 16 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 5 mg

Inactive Ingredients

Ingredient Name Strength
CITRIC ACID MONOHYDRATE
FD&C BLUE NO. 1
FD&C RED NO. 40
GLYCERIN
HYDROCHLORIC ACID
magnesium aluminum silicate
METHYLPARABEN
POTASSIUM SORBATE
water
SODIUM BENZOATE
TRISODIUM CITRATE DIHYDRATE
saccharin sodium
SUCROSE
XANTHAN GUM

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:42192-521-16 473 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2012-08-22


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Be sure to consult your doctor before taking any medication!
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