ACETAMINOPHEN  - acetaminophen liquid 
H.J. Harkins Company, Inc.

Children's Silapap Liquid

Active Ingredient: Acetaminophen 160 mg (in each 5 mL = 1 teaspoonful)

Purpose: Pain reliever/fever reducer

Uses temporarily relieves minor aches and pains due to: the common cold

• flu
  
• headache
  
• sore throat
  
• toothache
  
• temporarily reduces fever

Warnings

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

• more than 5 of the recommended doses per day
  
• 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 you consume 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 containing acetaminophen.

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

Keep out of reach of children.

Overdose Warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center 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 (5 mL)
children 4-5 years (36-47 lbs)	1 1/2 teaspoonfuls (7.5 mL)
children 6-8 years (48-59 lbs)	2 teaspoonfuls (10 mL)
children 9-10 years (60-71 lbs)	2 1/2 teaspoonfuls (12.5 mL)
children 11 years (72-95 lbs)	3 teaspoonfuls (15 mL)
adults & children 12 years & older	4 teaspoonfuls (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

Repacked by:

H.J. Harkins Company, Inc.
513 Sandydale Drive
Nipomo, CA 93444
USA

ACETAMINOPHEN  acetaminophen  liquid

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 52959-309 (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   sodium benzoate   water

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

Packaging # NDC Package Description Multilevel Packaging 1 52959-309-04 118 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	09/05/2023

Labeler - H.J. Harkins Company, Inc. (147681894)

Establishment
Name	Address	ID/FEI	Operations
Silarx Pharmaceuticals, Inc		161630033	manufacture

Revised: 12/2011H.J. Harkins Company, Inc.