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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Children's Silapap Liquid

Active Ingredient: Acetaminophen 160 mg (in each 5 mL (TSP))

Purpose: Pain reliever/fever reducer

Uses To reduce fever and for the temporary relief of minor aches and pains due to:

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 the user consumes 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 drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • if the user is allergic to acetaminophen or any of the inactive ingredients in this product

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
  • These could be signs of a serious condition

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

Keep out of reach of children.

Overdose Warning: In case of overdose, get medical help or contact a Poison Control Center (1800-222-1222) 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 (TSP)(5 mL)
children 4-5 years (36-47 lbs)
1 1/2 teaspoonfuls (TSP)(7.5 mL)
children 6-8 years (48-59 lbs)
2 teaspoonfuls (TSP)(10 mL)
children 9-10 years (60-71 lbs)
2 1/2 teaspoonfuls (TSP)(12.5 mL)
children 11 years (72-95 lbs)
3 teaspoonfuls (TSP)(15 mL)
adults & children 12 years & older
4 teaspoonfuls (TSP)(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
1033 Stoneleigh Ave.
Carmel, NY 10512
USA


Container Label 237 mL

CHILDRENS SILAPAP 
acetaminophen liquid
Product Information
Product TypeHUMAN OTC DRUG LABELItem 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 dihydrate 
sodium benzoate 
water 
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRY (cherry flavor) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54838-144-40118 mL in 1 BOTTLE, PLASTIC
2NDC:54838-144-70237 mL in 1 BOTTLE, PLASTIC
3NDC:54838-144-80473 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34309/05/1994
Labeler - Silarx Pharmaceuticals, Inc (161630033)

Revised: 6/2014
Document Id: b8694264-a585-4994-83ec-594f2f5d1fab
Set id: 12f92dd0-5c7c-46f1-a44a-64af0f26686d
Version: 12
Effective Time: 20140627
 
Silarx Pharmaceuticals, Inc