PYRILAMINE-PHENYLEPHRINE- pyrilamine maleate and phenylephrine hydrochloride liquid 
Acella Pharmaceuticals, LLC

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.

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Drug Facts

Active Ingredients (in each 5 mL)Purpose
Pyrilamine Maleate 16 mgAntihistamine
Phenylephrine HCl 5 mgNasal Decongestant

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.
AgeDose
Adults and children 12 years of age and older1 to 2 teaspoonfuls
Children 6 to under 12 years of age1 teaspoonful
Children under 6 years of ageAs directed by a physician

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

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
PYRILAMINE-PHENYLEPHRINE 
pyrilamine maleate and phenylephrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42192-521
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRILAMINE MALEATE (UNII: R35D29L3ZA) (PYRILAMINE - UNII:HPE317O9TL) PYRILAMINE MALEATE16 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SUCROSE (UNII: C151H8M554)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPE, BUBBLE GUMImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42192-521-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product10/10/201201/31/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/10/201201/31/2016
Labeler - Acella Pharmaceuticals, LLC (825380939)
Registrant - Acella Pharmaceuticals, LLC (825380939)
Establishment
NameAddressID/FEIBusiness Operations
Acella Pharmaceuticals, LLC825380939manufacture(42192-521)

Revised: 9/2018
Document Id: d68b7a78-c33e-49a1-9be5-258a6ed7a018
Set id: 1089fc64-2296-4c80-a0db-efd50e693a25
Version: 4
Effective Time: 20180912
 
Acella Pharmaceuticals, LLC