Childrens Plus Cough And Runny Nose
Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide
Freds Inc
Human Otc Drug
NDC 55315-297Childrens Plus Cough And Runny Nose also known as Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide is a human otc drug labeled by 'Freds Inc'. National Drug Code (NDC) number for Childrens Plus Cough And Runny Nose is 55315-297. This drug is available in dosage form of Suspension. The names of the active, medicinal ingredients in Childrens Plus Cough And Runny Nose drug includes Acetaminophen - 160 mg/5mL Chlorpheniramine Maleate - 1 mg/5mL Dextromethorphan Hydrobromide - 5 mg/5mL . The currest status of Childrens Plus Cough And Runny Nose drug is Active.
Drug Information:
| Drug NDC: | 55315-297 |
| 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 Plus Cough And Runny Nose |
| 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, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Freds Inc |
| 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
CHLORPHENIRAMINE MALEATE - 1 mg/5mL
DEXTROMETHORPHAN HYDROBROMIDE - 5 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 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: | 17 Dec, 2015 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 17 Dec, 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: | part341 |
| 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: | 24 Dec, 2025 |
| 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: | Freds Inc
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1086750
|
| 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. |
| UPC: | 0084579101153
|
| UPC stands for Universal Product Code. |
| UNII: | 362O9ITL9D
V1Q0O9OJ9Z
9D2RTI9KYH
|
| 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. |
| Pharmacologic Class: | Histamine H1 Receptor Antagonists [MoA]
Histamine-1 Receptor Antagonist [EPC]
Sigma-1 Agonist [EPC]
Sigma-1 Receptor Agonists [MoA]
Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]
Uncompetitive NMDA Receptor Antagonists [MoA]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 55315-297-04 | 1 BOTTLE, PLASTIC in 1 BOX (55315-297-04) / 118 mL in 1 BOTTLE, PLASTIC | 17 Dec, 2015 | 17 Dec, 2025 | 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:
Purposes pain reliever/fever reducer antihistamine cough suppressant
Product Elements:
Childrens plus cough and runny nose acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide acetaminophen acetaminophen chlorpheniramine maleate chlorpheniramine dextromethorphan hydrobromide dextromethorphan acesulfame potassium carboxymethylcellulose sodium cellulose, microcrystalline anhydrous citric acid glycerin high fructose corn syrup water d&c red no. 33 fd&c red no. 40 sodium benzoate sorbitol xanthan gum alcohol
Indications and Usage:
Uses temporarily relieves the following cold/flu symptoms: minor aches and pains sore throat cough sneezing and runny nose headache temporarily reduces fever
Warnings:
Warnings liver warning : this product contains acetaminophen. severe liver damage may occur if your child takes: more than 5 doses (10 ml) in 24 hours, which is the maximum daily amount with other drugs contaning 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, nausea, or vomiting, consult a doctor promptly. do not use to make a child sleepy in a child who is taking a prescription monoamine oxidase inhibitor (maoi) (certain drugs for depression, psychiatric or emotional conditions, or parkinsonâs disease), or for 2 weeks after stopping the maoi drug. if you do not know if your child's prescription drug contains an maoi, ask a doctor or pharmacist before giving this product. with any other drug containing a
Read more...cetaminophen (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 the child has liver disease glaucoma a breathing problem such as chronic bronchitis cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with asthma ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers the blood thinning drug warfarin when using this product do not exceed recommended dose ( see overdose warning ) excitability may occur, especially in children marked drowsiness may occur sedatives and tranquilizers may increase drowsiness stop use and ask a doctor if new symptoms occur fever gets worse or lasts for more than 3 days redness or swelling is present pain or cough gets worse or lasts for more than 5 days cough comes back or occurs with rash or headache that lasts these could be signs of a serious condition. keep out of reach of children. 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 (1-800-222-1222) right away. quick medical attention is critical even if you do not notice any signs or symptoms.
Do Not Use:
Warnings liver warning : this product contains acetaminophen. severe liver damage may occur if your child takes: more than 5 doses (10 ml) in 24 hours, which is the maximum daily amount with other drugs contaning 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, nausea, or vomiting, consult a doctor promptly. do not use to make a child sleepy in a child who is taking a prescription monoamine oxidase inhibitor (maoi) (certain drugs for depression, psychiatric or emotional conditions, or parkinsonâs disease), or for 2 weeks after stopping the maoi drug. if you do not know if your child's prescription drug contains an maoi, ask a doctor or pharmacist before giving this product. with any other drug 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 the child has liver disease glaucoma a breathing problem such as chronic bronchitis cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with asthma ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers the blood thinning drug warfarin when using this product do not exceed recommended dose ( see overdose warning ) excitability may occur, especially in children marked drowsiness may occur sedatives and tranquilizers may increase drowsiness stop use and ask a doctor if new symptoms occur fever gets worse or lasts for more than 3 days redness or swelling is present pain or cough gets worse or lasts for more than 5 days cough comes back or occurs with rash or headache that lasts these could be signs of a serious condition. keep out of reach of children. 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 (1-800-222-1222) right away. quick medical attention is critical even if you do not notice any signs or symptoms.
When Using:
When using this product do not exceed recommended dose ( see overdose warning ) excitability may occur, especially in children marked drowsiness may occur sedatives and tranquilizers may increase drowsiness
Dosage and Administration:
Directions this product does not contain directions or complete warnings for adult use. ml = milliliter shake well before using do not give more than 5 doses in any 24-hour period measure only with dosing cup provided. do not use any other dosing device. keep dosing cup with product if needed, repeat dose every 4 hours while symptoms last find the right dose on chart below. if possible, use weight to dose; otherwise, use age weight (lb) age (yr) dose (ml) 48-95 6-11 10 ml 36-47 4-5 do not use unless directed by a doctor under 36 under 4 do not use
Stop Use:
Stop use and ask a doctor if new symptoms occur fever gets worse or lasts for more than 3 days redness or swelling is present pain or cough gets worse or lasts for more than 5 days cough comes back or occurs with rash or headache that lasts these could be signs of a serious condition.
Package Label Principal Display Panel:
Principal display panel *compare to active ingredients in children's tylenol® plus cough & runny nose children's plus cough & runny nose pain reliever, fever reducer, cough suppressant, antihistamine relieves: fever & sore throat acetaminophen sneezing & runny nose chlorpheniramine maleate cough dextromethorphan hbr alcohol 0.005% oral suspension for ages 6 to 11 years fl oz (ml) cherry *this product is not manufactured or distributed by mcneil consumer healthcare, distributor of children's tylenol® plus cough & runny nose. tamper evident: do not use if printed safety seal around bottle or under cap is broken or missing . keep outer carton for complete warnings and product information. distributed by: fred's, inc. 4300 new getwell rd, memphis,tn 38118 www.fredsinc.com questions or comments: 1855-331-fred (3733)
Package label fred's children's plus cough & runny nose cherry flavor acetaminophen 160 mg, chlorpheniramine maleate 1 mg, dextromethorphan hbr 5 mg
Further Questions:
Questions or comments? call 1-877-753-3935 monday-friday 9am-5pm est