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Childrens Silapap

Silarx Pharmaceuticals, Inc

Children's Silapap Liquid


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient

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

Purpose

Purpose: Pain reliever/fever reducer

Uses

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


Childrens Silapap

Childrens Silapap

Acetaminophen LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) 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 DIHYDRATE
SODIUM BENZOATE
water

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:54838-144-40 118 in 1 BOTTLE, PLASTIC
2 NDC:54838-144-70 237 in 1 BOTTLE, PLASTIC
3 NDC:54838-144-80 473 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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