Childrens Silapap
FDA Label NDC 21695-244

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rebel Distributors Corp for the product Childrens Silapap (NDC 21695-244). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Otc - Active Ingredient

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

Otc - 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.

Otc - Do Not Use

Do not use

  • with any other product containing acetaminophen.

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Overdosage

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
Repackaged by:

Rebel Distributors Corp

Thousand Oaks, CA 91320

Package Label.Principal Display Panel

Acetaminophen 180mg / 5ml (50fca3de 4703 4eb7 8294 1ce8e860a100 01)

Acetaminophen 180mg / 5ml (50fca3de 4703 4eb7 8294 1ce8e860a100 01)

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