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 (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
19 West Street
Spring Valley, NY 10977
USA

CHILDRENS SILAPAP
acetaminophen liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:54838-144
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Acetaminophen (Acetaminophen)	Acetaminophen	160 mg in 5 mL

Inactive Ingredients
Ingredient Name	Strength
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
Shape		Size
Flavor	CHERRY (cherry flavor)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:54838-144-40	118 mL in 1 BOTTLE, PLASTIC	None
2	NDC:54838-144-70	237 mL in 1 BOTTLE, PLASTIC	None
3	NDC:54838-144-80	473 mL in 1 BOTTLE, PLASTIC	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	09/05/1994

Labeler - Silarx Pharmaceuticals, Inc (161630033)

Revised: 06/2012 Silarx Pharmaceuticals, Inc