SILAFED- pseudoephedrine hydrochloride and triprolidine hydrochloride syrup

Silafed by

Drug Labeling and Warnings

Silafed by is a Otc medication manufactured, distributed, or labeled by Lannett Company, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

PURPOSE

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

INDICATIONS & USAGE

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 DOCTOR

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

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

Stop use and ask a doctor if

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

PREGNANCY

If pregnant or breast-feeding, ask a health professional before use. 

KEEP OUT OF REACH OF CHILDREN

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SILAFED 
pseudoephedrine hydrochloride and triprolidine hydrochloride syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54838-101
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)	PSEUDOEPHEDRINE HYDROCHLORIDE	30 mg  in 5 mL
TRIPROLIDINE HYDROCHLORIDE (UNII: YAN7R5L890) (TRIPROLIDINE - UNII:2L8T9S52QM)	TRIPROLIDINE HYDROCHLORIDE	1.25 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54838-101-40	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/05/1988
2	NDC: 54838-101-70	237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/05/1988

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	10/05/1988

Labeler - Lannett Company, Inc. (161630033)