CHILDRENS SILAPAP- acetaminophen liquid

Childrens Silapap by

Drug Labeling and Warnings

Childrens Silapap by is a Otc medication manufactured, distributed, or labeled by Preferred 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

Relabeled By: Preferred Pharmaceuticals Inc.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CHILDRENS SILAPAP 
acetaminophen liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68788-6886(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 SODIUM (UNII: SB8ZUX40TY)
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: 68788-6886-1	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	02/01/2017

Labeler - Preferred Pharmaceuticals Inc. (791119022)

Registrant - Preferred Pharmaceuticals Inc. (791119022)

Establishment
Name	Address	ID/FEI	Business Operations
Preferred Pharmaceuticals Inc.		791119022	RELABEL(68788-6886)