Childrens Silapap
Acetaminophen
Proficient Rx Lp
Human Otc Drug
NDC 63187-294Childrens Silapap also known as Acetaminophen is a human otc drug labeled by 'Proficient Rx Lp'. National Drug Code (NDC) number for Childrens Silapap is 63187-294. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Childrens Silapap drug includes Acetaminophen - 160 mg/5mL . The currest status of Childrens Silapap drug is Active.
Drug Information:
| Drug NDC: | 63187-294 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Childrens Silapap |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Acetaminophen |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Proficient Rx Lp |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Liquid |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | ACETAMINOPHEN - 160 mg/5mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | ORAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | OTC MONOGRAPH NOT FINAL |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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. |
| Marketing Start Date: | 05 Sep, 1994 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 08 May, 2026 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | part343 |
| 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. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Proficient Rx LP
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 307675
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| UNII: | 362O9ITL9D
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 63187-294-04 | 118 mL in 1 BOTTLE, PLASTIC (63187-294-04) | 01 Dec, 2018 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Purpose: pain reliever/fever reducer
Product Elements:
Childrens silapap acetaminophen acetaminophen acetaminophen anhydrous citric acid d&c red no. 33 fd&c red no. 40 methylparaben propylene glycol saccharin sodium sodium benzoate water cherry flavor
Indications and 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:
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
Read more... 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.
Do Not Use:
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.
When Using:
When using this product ⢠do not exceed recommended dose (see overdose warning)
Dosage and Administration:
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)
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.
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.
Package Label Principal Display Panel:
63187-294-04
Further Questions:
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: proficient rx lp thousand oaks, ca 91320