Acetaminophen by H.J. Harkins Company, Inc. / Silarx Pharmaceuticals, Inc ACETAMINOPHEN liquid

Acetaminophen by

Drug Labeling and Warnings

Acetaminophen by is a Otc medication manufactured, distributed, or labeled by H.J. Harkins Company, Inc., Silarx Pharmaceuticals, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

PURPOSE

Purpose: Pain reliever/fever reducer

INDICATIONS & USAGE

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN 
acetaminophen liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52959-309(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: 52959-309-04	118 mL in 1 BOTTLE, PLASTIC

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

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

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