Childrens Silfedrine description, usages, side effects, indications, overdosage, supplying and lots more!

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Childrens Silfedrine

Silarx Pharmaceuticals, Inc

Children's Silfedrine Liquid


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient

Active Ingredient: Pseudoephedrine hydrochloride 15 mg (in each 5 mL(teaspoonful)(TSP))

Purpose

Purpose: Nasal decongestant

Uses

Uses temporarily relieves nasal congestion due to

  • common cold
  • hay fever
  • other upper respiratory allergies
  • temporarily relieves sinus congestion and pressure
  • promotes nasal and/or sinus drainage

Warnings

DO NOT USE IN CHILDREN UNDER 4 YEARS OF AGE

  • 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

  • heart diseases
  • high blood pressure
  • thyroid disease
  • diabetes

When using this product do not use more than directed

Stop use and ask a doctor if

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

Keep out of reach of children. In case of overdose, get medical help or contact a poison control center right away (1800-222-1222).

Directions

  • Do not exceed 4 doses in 24 hours.
  • Repeat dose every 4 hours if needed.
Children 6 to 11 years of age
2 teaspoonfuls (TSP)
Children 4 to 5 years of age
1 teaspoonful(TSP)
Children under 4 years of age DO NOT USE

Other information

store at room temperature

Inactive ingredients

citric acid, FD&C blue no. 1, FD&C red no. 40, glycerin, grape flavor, purified water, saccharin sodium, sodium benzoate, sodium citrate, sorbitol solution.

Questions

888-974-5279

Manufactured by:

Silarx Pharmaceuticals, Inc
1033 Stoneleigh Ave
Carmel, NY 10512 USA


Childrens Silfedrine


Childrens Silfedrine


Childrens Silfedrine

Pseudoephedrine hydrochloride LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:54838-104
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Pseudoephedrine Hydrochloride Pseudoephedrine 15 mg

Inactive Ingredients

Ingredient Name Strength
ANHYDROUS CITRIC ACID
FD&C BLUE NO. 1
FD&C RED NO. 40
GLYCERIN
SACCHARIN SODIUM DIHYDRATE
SODIUM BENZOATE
SODIUM CITRATE
sorbitol
water

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:54838-104-40 118 in 1 BOTTLE, PLASTIC
2 NDC:54838-104-70 237 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2001-01-05


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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