FDA Label for Childrens Silapap

View Indications, Usage & Precautions

Childrens Silapap Product Label

The following document was submitted to the FDA by the labeler of this product Preferred Pharmaceuticals Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



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


Otc - 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.


Otc - Do Not Use



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

Otc - When Using



When using this product

  • do not exceed recommended dose (see overdose warning)

Otc - Stop Use



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.


Otc - Keep Out Of Reach Of Children



Keep out of reach of children.


Overdosage



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.


* Please review the disclaimer below.