NDC 63187-294 Childrens Silapap

Acetaminophen

NDC Product Information

Childrens Silapap with NDC 63187-294 is a a human over the counter drug product labeled by Proficient Rx Lp. The generic name of Childrens Silapap is acetaminophen. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Proficient Rx Lp

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Childrens Silapap Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • ACETAMINOPHEN 160 mg/5mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • 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)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Proficient Rx Lp
Labeler Code: 63187
FDA Application Number: part343 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 09-05-1994 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

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Information for Patients

Acetaminophen

Acetaminophen is pronounced as (a set a mee' noe fen)

Why is acetaminophen medication prescribed?
Acetaminophen is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to va...
[Read More]

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Childrens Silapap Product Label Images

Childrens Silapap Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

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 conditionIf 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, Inc1033 Stoneleigh Ave.Carmel, NY 10512USARelabeled by:Proficient Rx LPThousand Oaks, CA 91320

* Please review the disclaimer below.