Multi Symptom Severe Cold And Nighttime Severe Cold And Cough
Acetaminophen, Dextromethorphan Hbr, Diphenhydramine Hcl, Phenylephrine Hcl
Wal-mart Stores Inc
Human Otc Drug
NDC 49035-948Multi Symptom Severe Cold And Nighttime Severe Cold And Cough also known as Acetaminophen, Dextromethorphan Hbr, Diphenhydramine Hcl, Phenylephrine Hcl is a human otc drug labeled by 'Wal-mart Stores Inc'. National Drug Code (NDC) number for Multi Symptom Severe Cold And Nighttime Severe Cold And Cough is 49035-948. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Multi Symptom Severe Cold And Nighttime Severe Cold And Cough drug includes . The currest status of Multi Symptom Severe Cold And Nighttime Severe Cold And Cough drug is Active.
Drug Information:
| Drug NDC: | 49035-948 |
| 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: | Multi Symptom Severe Cold And Nighttime Severe Cold And Cough |
| 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, Dextromethorphan Hbr, Diphenhydramine Hcl, Phenylephrine Hcl |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Wal-mart Stores Inc |
| 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: | 01 Jul, 2019 |
| 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: | 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: | WAL-MART STORES INC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1189316
1659960
1804449
|
| 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: | |
| 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 |
|---|
| 49035-948-12 | 1 KIT in 1 CARTON (49035-948-12) * 6 PACKET in 1 CARTON / 1 POWDER, FOR SOLUTION in 1 PACKET * 6 PACKET in 1 CARTON / 1 POWDER, FOR SOLUTION in 1 PACKET | 01 Jul, 2019 | 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 - multi symptom severe cold pain reliever/fever reducer cough suppressant nasal decongestant
Purpose - nighttime severe cold and cough pain reliever/fever reducer antihistamine/cough suppressant nasal decongestant
Product Elements:
Multi symptom severe cold and nighttime severe cold and cough acetaminophen, dextromethorphan hbr, diphenhydramine hcl, phenylephrine hcl multi symptom severe cold multi symptom severe cold acetaminophen, dextromethorphan hbr, phenylephrine hcl acetaminophen acetaminophen dextromethorphan hydrobromide dextromethorphan phenylephrine hydrochloride phenylephrine anhydrous citric acid caramel maltodextrin potassium chloride silicon dioxide sucralose sucrose nighttime severe cold and cough nighttime severe cold and cough acetaminophen, diphenhydramine hcl, phenylephrine hcl acetaminophen acetaminophen diphenhydramine hydrochloride diphenhydramine phenylephrine hydrochloride phenylephrine anhydrous citric acid fd&c yellow no. 6 maltodextrin potassium chloride silicon dioxide sucralose sucrose
Indications and Usage:
Uses - multi symptom severe cold temporarily relieves these symptoms due to a cold: minor aches and pains minor sore throat pain headache nasal and sinus congestion cough due to minor throat and bronchial irritation temporarily reduces fever
Uses - nighttime severe cold and cough temporarily relieves these symptoms due to a cold: minor aches and pains minor sore throat pain headache nasal and sinus congestion runny nose sneezing itchy nose or throat itchy, watery eyes due to hay fever cough due to minor throat and bronchial irritation temporarily reduces fever
Warnings:
Warnings multi symptom severe cold /nighttime severe cold and cough liver warning : this product contains acetaminophen. severe liver damage may occur if you take more than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product 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:
Warnings multi symptom severe cold /nighttime severe cold and cough liver warning : this product contains acetaminophen. severe liver damage may occur if you take more than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product 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.
When Using:
When using this product - multi symptom severe cold do not exceed recommended dosage
When using this product - nighttime severe cold and cough do not exceed recommended dosage avoid alcoholic drinks marked drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children
Dosage and Administration:
Directions multi symptom severe cold do not use more than directed take every 4 hours, while symptoms persist .do not take more than 6 packets in 24 hours unless directed by a doctor age dose adults and children 12 years of age one packet children under 12 years of age do not use dissolve contents of one packet into 8 oz. hot water: sip while hot. consume entire drink within 10 - 15 minutes. if using a microwave, add contents of one packet to 8 oz. of cool water: stir briskly before and after heating, do not overheat directions nighttime severe cold and cough do not use more than directed take every 4 hours while symptoms persist, not to exceed 5 packets in 24 hours unless directed by a doctor age dose adults and children 12 years of age and over one packet children under 12 years of age do not use dissolve contents of one packet into 8 oz. hot water: sip while hot. consume entire drink within 10 - 15 minutes. if using a microwave, add contents of one packet
Read more...to 8 oz. of cool water: stir briskly before and after heating, do not overheat.
Directions nighttime severe cold and cough do not use more than directed take every 4 hours while symptoms persist, not to exceed 5 packets in 24 hours unless directed by a doctor age dose adults and children 12 years of age and over one packet children under 12 years of age do not use dissolve contents of one packet into 8 oz. hot water: sip while hot. consume entire drink within 10 - 15 minutes. if using a microwave, add contents of one packet to 8 oz. of cool water: stir briskly before and after heating, do not overheat.
Stop Use:
Stop use and ask a doctor if multi symptom severe cold /nighttime severe cold and cough nervousness, dizziness, or sleeplessness occurs fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur pain, cough or nasal congestion gets worse or lasts more than 7 days cough comes back or occurs with fever, rash or headache that lasts. these could be signs of a serious condition.
Package Label Principal Display Panel:
Package/label principal display panel ndc# 49035-948-12 daytime & nighttime relief value pack compare to active ingredients in theraflu® multi symptom severe cold* and nighttime severe cold & cough * multi- symptom severe cold acetaminophen / pain reliever/ fever reducer dextromethorphan hbr / cough suppressant phenylephrine hcl / nasal decongestant dye free aspartame free sodium free relieves nasal congestion sore throat pain cough headache body ache fever green tea & honey lemon flavors infused with menthol and green tea flavor naturally and artificially flavored 6 multi-symptom packets nighttime severe & cold & cough acetaminophen/ pain reliever/ fever reducer diphenhydramine hcl / antihistamine/ cough suppressant phenylephrine hcl / nasal decongestant aspartame free sodium free relieves nasal congestion sore throat pain cough headache body ache & fever runny nose sneezing honey lemon flavor infused with chamomile &white tea flavors 6 nighttime packets 12 total packets read all warnings and directions on carton before use .keep carton for reference, do not discard. do not take both products at the same time or take more than 5 doses in total in any 24 hour period. do not take a dose of the nighttime product sooner than 4 hours after the last dose of daytime product unless directed by doctor. *these products are not manufactured or distributed by gsk consumer healthcare, distributor of theraflu ® multi-symptom severe cold & theraflu ® nighttime severe cold & cough. distributed by: wal-mart stores, inc. bentoville, ar 72716 © wal-mart stores, inc. *this product is not manufactured or distributed by novartis consumer health inc., owner of the registered trademark gas-x®. tamper evident inner unit: do not use if sealed packet is torn or broken daytime and nighttime relief value pack
Further Questions:
Questions or comments? 1-866-467-2748