CHILDRENS SILAPAP- acetaminophen liquid

Childrens Silapap by

Drug Labeling and Warnings

Childrens Silapap by is a Otc medication manufactured, distributed, or labeled by NuCare Pharmaceuticals,Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

PURPOSE

Purpose: Pain reliever/fever reducer

INDICATIONS & USAGE

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CHILDRENS SILAPAP 
acetaminophen liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68071-4052(NDC:54838-144)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	160 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C RED NO. 40 (UNII: WZB9127XOA)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SACCHARIN (UNII: FST467XS7D)
SODIUM BENZOATE (UNII: OJ245FE5EU)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY (cherry flavor)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68071-4052-4	120 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/16/2017

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

Labeler - NuCare Pharmaceuticals,Inc. (010632300)

Establishment
Name	Address	ID/FEI	Business Operations
NuCare Pharmaceuticals,Inc.		010632300	relabel(68071-4052)