Childrens Pain Relief Oral Suspension
Acetaminophen
Pharmacy Value Alliance, Llc
Human Otc Drug
NDC 68016-240Childrens Pain Relief Oral Suspension also known as Acetaminophen is a human otc drug labeled by 'Pharmacy Value Alliance, Llc'. National Drug Code (NDC) number for Childrens Pain Relief Oral Suspension is 68016-240. This drug is available in dosage form of Suspension. The names of the active, medicinal ingredients in Childrens Pain Relief Oral Suspension drug includes Acetaminophen - 160 mg/5mL . The currest status of Childrens Pain Relief Oral Suspension drug is Active.
Drug Information:
| Drug NDC: | 68016-240 |
| 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 Pain Relief Oral Suspension |
| 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: | Pharmacy Value Alliance, Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Suspension |
| 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: | 01 Oct, 2018 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 16 Jan, 2025 |
| 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: | Pharmacy Value Alliance, LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 307668
|
| 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. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| 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 |
|---|
| 68016-240-04 | 1 BOTTLE in 1 CARTON (68016-240-04) / 118 mL in 1 BOTTLE | 01 Oct, 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 acetaminophen.... pain reliever/fever reducer
Product Elements:
Childrens pain relief oral suspension acetaminophen acetaminophen acetaminophen anhydrous citric acid butylparaben fd&c red no. 40 glycerin high fructose corn syrup microcrystalline cellulose carboxymethylcellulose sodium propylene glycol water sodium benzoate sorbitol sucrose xanthan gum
Indications and Usage:
Uses temporarily ? reduces fever ? relieves minor aches and pains due to: ? the common cold ? flu ? headache ? sore throat ? toothache
Warnings:
Warnings liver warning this product contains acetaminophen. severe liver damage may occur if your child takes: ? more than 5 doses in 24 hours, which is the maximum daily amount ? with other drugs containing acetaminophen allergy alert: acetaminophen may cause severe skin reactions. symptoms may include: ? skin reddening ? blisters ?rash if a skin reaction occurs, stop use and seek medical help right away. sore throat warning if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash,
Do Not Use:
Warnings liver warning this product contains acetaminophen. severe liver damage may occur if your child takes: ? more than 5 doses in 24 hours, which is the maximum daily amount ? with other drugs containing acetaminophen allergy alert: acetaminophen may cause severe skin reactions. symptoms may include: ? skin reddening ? blisters ?rash if a skin reaction occurs, stop use and seek medical help right away. sore throat warning if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash,
When Using:
When using this product do not exceed recommended dose (see overdose warning)
Dosage and Administration:
Directions ? this product does not contain directions or complete warnings for adult use. ? shake well before using ? ml = milliliter; tsp = teaspoonful ? find right dose on chart below. if possible, use weight to dose; otherwise, use age. ? if needed, repeat dose every 4 hours while symptoms last ? do not give more than 5 times in 24 hours ? do not give for more than 5 days unless directed by adoctor. weight (ib) age (yr) dose (ml or tsp)* under 24 under 2 years ask a doctor 24-35 2-3 years 5 ml (1 tsp) 36-47 4-5 years 7.5 ml (1 y2 tsp) 48-59 6-8 years 10 ml (2 tsp) 60-71 9-10 year 12.5 ml (2y2 tsp) 72-95 11 year 15 ml (3 tsp) *or as directed by a doctor attention: use only enclosed dosing cup specifically designed for use with this product. do not use any other dosing device.
Stop Use:
Stop use and ask a doctor if ? pain gets worse or lasts more than 5 days ? fever gets worse or lasts more than 3 days ? new symptoms occur ? redness or swelling is present these could be signs of a serious condition.
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. (1-800-222-1222) quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Package Label Principal Display Panel:
Principal display panel premier value ® children's pain relief pain reliever fever reducer acetaminophen oral suspension cherry flavor premier value ® compare to the active ingredients in children's tylenol ® oral suspension** ages 2-11 years children's pain relief pain reliever fever reducer acetaminophen oral suspension 160 mg per 5 ml alcohol free aspirin free ibuprofen free use only enclosed dosage cup cherry flavor 4 fl ox (118 ml) independently tested pv satisfaction guaranteed do not use if printed neck band is broken or missing if for any reason you are not satisfied with this product, please return it to the store where purchased for a full refund. distributed by: pharmacy value alliance llc 407 east lancaster avenue, wayne, pa 19087 **this product is not manufactured or distributed by mcneil consumer healthcare, distributor of children's tyleno! ® oral suspension. bx-072 711198 10/17 product label premier value ® children's pain relief acetaminophen oral suspension cherry flavor end res 240-04 outer 240-04 inner
Further Questions:
Questions? call weekdays from 9:30 am to 4:30 pm est at 1-877-798-5944