Daytime Nighttime Multi Symptom Cold Childrens
Dextromethorphan Hbr,guaifenesin,phenylephrine Hcl,acetaminophen,diphenhydramine Hcl, Phenylephrine Hcl
Walgreens
Human Otc Drug
NDC 0363-4200Daytime Nighttime Multi Symptom Cold Childrens also known as Dextromethorphan Hbr,guaifenesin,phenylephrine Hcl,acetaminophen,diphenhydramine Hcl, Phenylephrine Hcl is a human otc drug labeled by 'Walgreens'. National Drug Code (NDC) number for Daytime Nighttime Multi Symptom Cold Childrens is 0363-4200. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Daytime Nighttime Multi Symptom Cold Childrens drug includes . The currest status of Daytime Nighttime Multi Symptom Cold Childrens drug is Active.
Drug Information:
| Drug NDC: | 0363-4200 |
| 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: | Daytime Nighttime Multi Symptom Cold Childrens |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Daytime Nighttime Multi Symptom Cold |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | Childrens |
| A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard. |
| 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: | Dextromethorphan Hbr,guaifenesin,phenylephrine Hcl,acetaminophen,diphenhydramine Hcl, Phenylephrine Hcl |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Walgreens |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Kit |
| 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: | |
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | |
| 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: | 31 Dec, 2014 |
| 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: | 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: | 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: | Walgreens
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1043543
1375932
1606291
|
| 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: | 0311917168593
|
| UPC stands for Universal Product Code. |
| UNII: | |
| 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 |
|---|
| 0363-4200-08 | 1 KIT in 1 KIT (0363-4200-08) * 118 mL in 1 BOTTLE, PLASTIC (0363-4070-04) * 118 mL in 1 BOTTLE, PLASTIC (0363-4060-04) | 31 Dec, 2014 | 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:
Purposes for day time cough suppressant expectorant nasal decongestant
Purposes for night time pain reliever/fever reducer antihistamine/cough suppressant nasal decongestant
Product Elements:
Daytime nighttime multi symptom cold childrens dextromethorphan hbr,guaifenesin,phenylephrine hcl,acetaminophen,diphenhydramine hcl, phenylephrine hcl daytime multi symptom cold childrens dextromethorphan hbr,guaifenesin,phenylephrine hcl dextromethorphan hydrobromide dextromethorphan phenylephrine hydrochloride phenylephrine guaifenesin guaifenesin anhydrous citric acid edetate disodium fd&c red no. 40 glycerin propylene glycol propyl gallate water sodium benzoate sorbitol sucralose trisodium citrate dihydrate xanthan gum nighttime multi symptom cold childrens acetaminophen,diphenhydramine hcl,phenylephrine hcl acetaminophen acetaminophen diphenhydramine hydrochloride diphenhydramine phenylephrine hydrochloride phenylephrine anhydrous citric acid edetate disodium fd&c blue no. 1 fd&c red no. 40 glycerin propylene glycol propyl gallate water sodium benzoate sorbitol sucralose trisodium citrate dihydrate xanthan gum
Indications and Usage:
Uses daytime helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants the intensity of coughing the impulse to cough to help your child get to sleep nasal congestion due to a cold stuffy nose nighttime temporarily relieves these common cold and flu symptoms: minor aches and pains headache sore throat sneezing runny nose nasal congestion cough controls cough to help your child get to sleep temporarily reduces fever
Warnings:
Warnings nighttime only 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, nausea, or vomiting, consult a doctor promptly. do not use daytime in a child who is taking a prescription monoamine oxidase inhibitor (maoi) (certan drugs for depression, psychiatric or emotional conditions, or parkinson's disease), or for 2 weeks after stopping the maoi drug. if you do not know if your childs prescription drug contains an maoi, ask a doctor or pharmacist before giving this product. nighttime with other drug containing acetamin
Read more...ophen (prescription or nonprescription). if you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. in a child who is taking a prescription monoamine oxidase inhibitor (maoi) (certain drugs for depression, psychiatric, or emotional conditions, or parkinson's 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 diphenhydramine even one used on the skin if your child is allergic to acetaminophen or any of the inactive ingredients in thia product to make a child sleepy ask a doctor before use your child has daytime heart disease high blood pressure diabetes thyroid disease cough that occurs with too much phlegm (mucus) persistent or chronic cough such occurs with asthma nighttime liver disease heart disease high blood disease diabetes thyroid disease glaucoma a breathing problem such as chronic bronchitis persistent or chronic cough such as occurs with asthma cough that occurs with too much phlegm (mucus) ask a doctor or pharmacist before use if the child is nighttime taking sedatives or tranquilizers. taking the blood thinning drug warfarin when using this product daytime do not use more than directed. nighttime do not use more than directed excitability may occur, especially in children marked drowsiness may ocur sedatives and tranquilizers may increase drowsiness stop use and ask a doctor if daytime nervousness, dizziness, or sleeplessness occur symptoms do not get better with 7 days or occur with fever cough lasts more than 7 days, comes back, or occurs with a fever, rash, or headache that lasts.these could be signs of a serious condition. these could be signs of a serious condition. nighttime nervousness, dizziness, or sleeplessness occur pain, nasal congestion, or cough gets worse or lasts more than 5 days redness or swelling is present new symptoms occur fever gets worse or lasts more than 3 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. daytime in case of overdose, get medical help or contact a poison control center (1-800-222-1222) right away. nighttime 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 even if you not notice any signs or symptoms.
Do Not Use:
Warnings nighttime only 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, nausea, or vomiting, consult a doctor promptly. do not use daytime in a child who is taking a prescription monoamine oxidase inhibitor (maoi) (certan drugs for depression, psychiatric or emotional conditions, or parkinson's disease), or for 2 weeks after stopping the maoi drug. if you do not know if your childs prescription drug contains an maoi, ask a doctor or pharmacist before giving this product. nighttime with other drug containing acetaminophen (prescription or nonprescription). if you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. in a child who is taking a prescription monoamine oxidase inhibitor (maoi) (certain drugs for depression, psychiatric, or emotional conditions, or parkinson's 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 diphenhydramine even one used on the skin if your child is allergic to acetaminophen or any of the inactive ingredients in thia product to make a child sleepy ask a doctor before use your child has daytime heart disease high blood pressure diabetes thyroid disease cough that occurs with too much phlegm (mucus) persistent or chronic cough such occurs with asthma nighttime liver disease heart disease high blood disease diabetes thyroid disease glaucoma a breathing problem such as chronic bronchitis persistent or chronic cough such as occurs with asthma cough that occurs with too much phlegm (mucus) ask a doctor or pharmacist before use if the child is nighttime taking sedatives or tranquilizers. taking the blood thinning drug warfarin when using this product daytime do not use more than directed. nighttime do not use more than directed excitability may occur, especially in children marked drowsiness may ocur sedatives and tranquilizers may increase drowsiness stop use and ask a doctor if daytime nervousness, dizziness, or sleeplessness occur symptoms do not get better with 7 days or occur with fever cough lasts more than 7 days, comes back, or occurs with a fever, rash, or headache that lasts.these could be signs of a serious condition. these could be signs of a serious condition. nighttime nervousness, dizziness, or sleeplessness occur pain, nasal congestion, or cough gets worse or lasts more than 5 days redness or swelling is present new symptoms occur fever gets worse or lasts more than 3 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. daytime in case of overdose, get medical help or contact a poison control center (1-800-222-1222) right away. nighttime 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 even if you not notice any signs or symptoms.
When Using:
When using this product daytime do not use more than directed. nighttime do not use more than directed excitability may occur, especially in children marked drowsiness may ocur sedatives and tranquilizers may increase drowsiness
Dosage and Administration:
Directions daytime do not take more than 6 doses in any 24-hour period use only the enclosed dosing cup designed for use with this product. do not use any other dosing device. keep dosing cup with product dose as follows or as directed by a doctor ml= milliliter age dose children 6 to under 12 years 10 ml every 4 hours children 4 to under 6 years 5 ml every 4 hours children under 4 years do not use nighttime this product does not contain directions or complete warnings for adult use do not give more than directed (see overdose warning ) do not give more than 5 doses in any 24-hour period if needed, repeat dose every 4 hours while symptoms last do not give more than 5 days unless directed by a doctor measure only with dosing cup provided. do not use any other dosing device ml = milliliter dose as follows or as directed by a doctor children 6 to under 12 years of age: 10 ml every 4 hours children under 6 years of age: do not use
Stop Use:
Stop use and ask a doctor if daytime nervousness, dizziness, or sleeplessness occur symptoms do not get better with 7 days or occur with fever cough lasts more than 7 days, comes back, or occurs with a fever, rash, or headache that lasts.these could be signs of a serious condition. these could be signs of a serious condition. nighttime nervousness, dizziness, or sleeplessness occur pain, nasal congestion, or cough gets worse or lasts more than 5 days redness or swelling is present new symptoms occur fever gets worse or lasts more than 3 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 the active ingredients in children's mucinex daytime multi-symptom cold & night time multi-symptom coldâ â children's multi-symptom cold dextromethorpan hbr 5 mg / cough suppressant guaifenesin 100 mg / expectorant phenylephrine hci 2.5 mg / nasal decongestant daytime alcohol free relief from chest congestion, cough & stuffy nose breaks up mucus ages 4 - 11 years berry flavor fl oz (ml) children's multi-symptom acetaminophen 325 mg / pain reliever / fever reducer diphenhydramine hci 12.5 mg / antihistamine / cough suppressant phenylephrine hci 5 mg / nasal decongestant nighttime alcohol free relief from stuffy nose, cough, fever, sore throat, runny nose & sneezing ages 6 - 11 years berry flavor fl oz (ml) 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 â â this product is not manufactured or distributed by reckitt benckiser, distributor of children's mucinex® night time multi-symptom cold and children's mucinex® multi-symptom cold distributed by; walgreen co. 200 wilmot rd., deerfield, il 60015 walgreens.com
Product label walgreens multi-symptom children's cold dextromethorphan hbr 5 mg, guaifenesin 100 mg, phenylephrine hcl 2.5 mg acetaminophen 325 mg, diphenhydramine hcl 12.5 mg, phenylephrine hcl 5 mg
Further Questions:
Questions or comments? call 1-877-753-3935 monday-friday 9am-5pm est