SILAFED- pseudoephedrine hydrochloride and triprolidine hydrochloride syrup 
Lannett Company, Inc.

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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Silafed Syrup

Active Ingredient: Pseudoephedrine hydrochloride 30 mg (in each 5 mL)
Active Ingredient: Triprolidine hydrochloride 1.25 mg (in each 5 mL)

Purpose of Pseudoephedrine hydrochloride: Nasal Decongestant
Purpose of Triprolidine hydrochloride: Antihistamine

Uses temporary relieves nasal congestion due to:

  • common cold
  • hay fever
  • other upper respiratory allergies
  • temporarily dries runny nose
  • temporarily relives:
    • sneezing
    • runny nose
    • itchy watery eyes and nose

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

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

Ask a doctor before use if you are taking sedatives or tranquilizers

When using this product

  • drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • may cause excitability in children
  • do not use more than directed

Stop use and ask a doctor if

  • symptoms do not improve within 7 days or accompanied by fever
  • nervousness, dizziness or sleeplessness occurs

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

Take dosage every 6 hours or as directed by doctor.

 Adults and children 12 years and over
 2 teaspoonfuls
 Children  under 12 years
 DO NOT USE

Other Information

Store at controlled room temperature 20°-25°C (68°-77°F). Protect from freezing.

Inactive Ingredients

citric acid, D&C yellow no. 10, methylparaben, propylene glycol, saccharin sodium, sodium benzoate, sodium citrate, sodium hydroxide, sucrose, and water.

Questions

888-974-5279


Container Label 118mL

Container Label 237mL
SILAFED 
pseudoephedrine hydrochloride and triprolidine hydrochloride syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54838-101
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE30 mg  in 5 mL
TRIPROLIDINE HYDROCHLORIDE (UNII: YAN7R5L890) (TRIPROLIDINE - UNII:2L8T9S52QM) TRIPROLIDINE HYDROCHLORIDE1.25 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SUCROSE (UNII: C151H8M554)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54838-101-40118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/05/198807/26/2022
2NDC:54838-101-70237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/05/198807/26/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/05/198807/26/2022
Labeler - Lannett Company, Inc. (002277481)

Revised: 12/2010
 
Lannett Company, Inc.