Acetaminophen description, usages, side effects, indications, overdosage, supplying and lots more!

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Acetaminophen

H.J. Harkins Company, Inc.

Children's Silapap Liquid


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient

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

Purpose

Purpose: Pain reliever/fever reducer

Uses

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

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

Acetaminophen LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:52959-309(NDC:54838-144)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 160 mg

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

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:52959-309-04 118 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 1994-09-05


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Be sure to consult your doctor before taking any medication!
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