Little Remedies Childrens Fever Pain Reliever
Acetaminophen
Medtech Products Inc.
Human Otc Drug
NDC 63029-603Little Remedies Childrens Fever Pain Reliever also known as Acetaminophen is a human otc drug labeled by 'Medtech Products Inc.'. National Drug Code (NDC) number for Little Remedies Childrens Fever Pain Reliever is 63029-603. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Little Remedies Childrens Fever Pain Reliever drug includes Acetaminophen - 160 mg/5mL . The currest status of Little Remedies Childrens Fever Pain Reliever drug is Active.
Drug Information:
| Drug NDC: | 63029-603 |
| 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: | Little Remedies Childrens Fever Pain Reliever |
| 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: | Medtech Products Inc. |
| 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: | 01 Sep, 2010 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 13 Jun, 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: | Medtech Products Inc.
|
| 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 |
|---|
| 63029-603-02 | 1 BOTTLE in 1 CARTON (63029-603-02) / 118 mL in 1 BOTTLE | 01 Sep, 2010 | 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:
Little remedies childrens fever pain reliever acetaminophen acetaminophen acetaminophen citric acid monohydrate glycerin potassium sorbate povidone propylene glycol water sodium citrate sucralose sucrose xanthan gum little remedies childrens fever pain reliever acetaminophen acetaminophen acetaminophen citric acid monohydrate glycerin potassium sorbate povidone propylene glycol water sodium citrate sucralose sucrose xanthan gum
Indications and Usage:
Uses temporarily: reduces fever relieves minor aches and pains which may be associated with the common cold, flu, headache, sore throat or 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 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, or is accompanied or followed by fever, headache, rash nausea or vomiting, consult a doctor promptly. do not use with any other products containing acetaminophen (prescription or non-prescription). if you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if your child is allergic to acetaminophen or any of the inactive ingredients in this product. ask a doctor before use if your child has liver disease. ask a doctor or pharmacist before use if the child is taking the blood thinning drug
Read more...warfarin. when using this product do not exceed recommended dosage (see overdose warning). stop use and ask a doctor if new symptoms occur fever gets worse or lasts more than 3 days pain gets worse or lasts more than 5 days redness or swelling is present these could be signs of a serious condition. keep out of reach of children. overdose warning taking more than the recommended dose (overdose) can cause serious liver damage. in case of overdose, get medical help or contact a poison control center right away (1-800-222-1222). prompt 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 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 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, or is accompanied or followed by fever, headache, rash nausea or vomiting, consult a doctor promptly. do not use with any other products containing acetaminophen (prescription or non-prescription). if you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if your child is allergic to acetaminophen or any of the inactive ingredients in this product. ask a doctor before use if your child has liver disease. ask a doctor or pharmacist before use if the child is taking the blood thinning drug warfarin. when using this product do not exceed recommended dosage (see overdose warning). stop use and ask a doctor if new symptoms occur fever gets worse or lasts more than 3 days pain gets worse or lasts more than 5 days redness or swelling is present these could be signs of a serious condition. keep out of reach of children. overdose warning taking more than the recommended dose (overdose) can cause serious liver damage. in case of overdose, get medical help or contact a poison control center right away (1-800-222-1222). prompt medical attention is critical even if you do not notice any signs of symptoms.
When Using:
When using this product do not exceed recommended dosage (see overdose warning).
Dosage and Administration:
Directions this product does not contain directions or complete warnings for adult use. do not give more than directed (see overdose warning). shake well before using. find the right dose on the chart below. (if possible, use weight to determine dosing; otherwise, use age.) pour liquid into accusafe® dosing cup to the appropriate amount for your child's weight and/or age. only use with enclosed accusafe® dosing cup. if needed, repeat dose every 4 hours while symptoms last. do not give more than 5 days in any 24-hour period (see overdose warning). do not give more than 5 days unless directed by a doctor. replace cap tightly to maintain child resistance. weight (lb) age (yr) dose under 24 under 2 ask a doctor 24-35 2 â under 4 5ml 36-47 4 â under 6 7.5ml 48-59 6 â under 9 10 ml 60-71 9 â under 11 12.5ml 72-95 11 â under 12 15ml
Stop Use:
Stop use and ask a doctor if new symptoms occur fever gets worse or lasts more than 3 days pain gets worse or lasts more than 5 days redness or swelling is present these could be signs of a serious condition.
Overdosage:
Overdose warning taking more than the recommended dose (overdose) can cause serious liver damage. in case of overdose, get medical help or contact a poison control center right away (1-800-222-1222). prompt medical attention is critical even if you do not notice any signs of symptoms.
Package Label Principal Display Panel:
Principal display panel little remedies® childrenâs fever + pain reliever acetaminophen natural cherry flavor 4 fl oz (118 ml) little remedies childrens fever cherry carton
Principal display panel little remedies® childrenâs fever + pain reliever acetaminophen natural grape flavor 4 fl oz (118 ml) little remedies childrens fever grape carton
Further Questions:
Questions? 1-800-754-8853 mon. â fri. 8:00 a.m. to 8:00 p.m. est littleremedies.com.