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Childrens Silapap by Preferred Pharmaceuticals Inc.

Medically reviewed on February 1, 2017

Dosage form: liquid
Ingredients: Acetaminophen 160mg in 5mL
Labeler: Preferred Pharmaceuticals Inc.
NDC Code: 68788-6886

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.

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:

Headache
Muscular aches
Backache
Minor pain of arthritis
The common cold
Toothache
Premenstrual and menstrual cramps

Warnings

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

more than 5 doses in 24 hours, which is the maximum daily amount
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product

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
do not take more than directed (see overdose warning).
if needed, repeat dose every 4 hours or as directed by a doctor
do not give more than 5 doses in 24 hours

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

Relabeled By: Preferred Pharmaceuticals Inc.

CHILDRENS SILAPAP 
acetaminophen liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68788-6886(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 Description
1NDC:68788-6886-1118 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34302/01/2017
Labeler - Preferred Pharmaceuticals Inc. (791119022)
Registrant - Preferred Pharmaceuticals Inc. (791119022)
Establishment
NameAddressID/FEIOperations
Preferred Pharmaceuticals Inc.791119022RELABEL(68788-6886)

 
Preferred Pharmaceuticals Inc.

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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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