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Silafed

Dosage form: syrup
Ingredients: Pseudoephedrine hydrochloride 30mg in 5mL, Triprolidine hydrochloride 1.25mg in 5mL
Labeler: Silarx Pharmaceuticals, Inc
NDC Code: 54838-101

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.

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



SILAFED 
pseudoephedrine hydrochloride and triprolidine hydrochloride syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54838-101
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Pseudoephedrine hydrochloride (Pseudoephedrine) Pseudoephedrine hydrochloride30 mg  in 5 mL
Triprolidine hydrochloride (Triprolidine) Triprolidine hydrochloride1.25 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
anhydrous citric acid 
D&C yellow no. 10 
methylparaben 
propylene glycol 
saccharin sodium 
sodium benzoate 
sodium citrate 
sodium hydroxide 
sucrose 
water 
Packaging
#Item CodePackage Description
1NDC:54838-101-40118 mL in 1 BOTTLE, PLASTIC
2NDC:54838-101-70237 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/05/1988
Labeler - Silarx Pharmaceuticals, Inc (161630033)

Revised: 12/2010
 
Silarx Pharmaceuticals, Inc

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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