CHILDRENS SILAPAP  - acetaminophen liquid 
Silarx Pharmaceuticals, 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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Active Ingredient: Acetaminophen 160 mg (in each 5 mL = 1 teaspoonful)

Purpose: Pain reliever/fever reducer

Uses temporarily relieves minor aches and pains due to: the common cold

Warnings

Liver Warning:This product contains acetaminophen. Severe liver damage may occur if you take:

Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting, consult a doctor promptly.

Alcohol warning:If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers/fever reducers.

Do not use

  • with any other product containing acetaminophen.

When using this product

  • do not exceed recommended dose (see overdose warning)

Stop use and ask a doctor if

  • new symptoms occur
  • redness or swelling is present
  • pain gets worse or lasts for more than 5 days
  • fever gets worse or lasts for more than 3 days

Keep out of reach of children.

Overdose Warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical even if you do not notice any signs of symptoms.

Directions


children under 2 yrs (under 24 lbs)
ask a doctor
children 2-3 years (24-35 lbs)
1 teaspoonful (5 mL)
children 4-5 years (36-47 lbs)
1 1/2 teaspoonfuls (7.5 mL)
children 6-8 years (48-59 lbs)
2 teaspoonfuls (10 mL)
children 9-10 years (60-71 lbs)
2 1/2 teaspoonfuls (12.5 mL)
children 11 years (72-95 lbs)
3 teaspoonfuls (15 mL)
adults & children 12 years & older
4 teaspoonfuls (20 mL)
Other information
Store at room temperature 20°-25°C (68°-77°F)

Inactive ingredients

citric acid, D&C red no. 33, FD&C red no. 40, cherry flavor, methylparaben, propylene glycol, saccharin sodium, sodium benzoate, and purified water.

Questions

888-974-5279

This product is not manufactured or distributed by McNeil Consumer & Specialty Pharmaceuticals, distributor of Tylenol®.

Manufactured by:

Silarx Pharmaceuticals, Inc
19 West Street
Spring Valley, NY 10977
USA

Container Label 118 mL

Container Label 237 mL

Container Label 473 mL


CHILDRENS SILAPAP 
acetaminophen liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54838-144
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (Acetaminophen) Acetaminophen160 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
anhydrous citric acid 
D&C red no. 33 
FD&C red no. 40 
methylparaben 
propylene glycol 
saccharin sodium 
sodium benzoate 
water 
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRY (cherry flavor) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:54838-144-40118 mL in 1 BOTTLE, PLASTICNone
2NDC:54838-144-70237 mL in 1 BOTTLE, PLASTICNone
3NDC:54838-144-80473 mL in 1 BOTTLE, PLASTICNone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34309/05/1994

Labeler - Silarx Pharmaceuticals, Inc (161630033)

Revised: 11/2011 Silarx Pharmaceuticals, Inc