Harris Teeter Sinus Relief
Acetaminophen, Guaifenesin, Phenylephrine Hydrochloride, Diphenhydramine Hydrochloride
Harris Teeter, Llc
Human Otc Drug
NDC 69256-040Harris Teeter Sinus Relief also known as Acetaminophen, Guaifenesin, Phenylephrine Hydrochloride, Diphenhydramine Hydrochloride is a human otc drug labeled by 'Harris Teeter, Llc'. National Drug Code (NDC) number for Harris Teeter Sinus Relief is 69256-040. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Harris Teeter Sinus Relief drug includes . The currest status of Harris Teeter Sinus Relief drug is Active.
Drug Information:
| Drug NDC: | 69256-040 |
| 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: | Harris Teeter Sinus Relief |
| 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, Guaifenesin, Phenylephrine Hydrochloride, Diphenhydramine Hydrochloride |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Harris Teeter, Llc |
| 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: | 17 Dec, 2019 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 10 May, 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: | Harris Teeter, LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1233575
1243679
1941459
|
| 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 |
|---|
| 69256-040-80 | 1 KIT in 1 KIT (69256-040-80) * 2 TABLET, FILM COATED in 1 BLISTER PACK * 2 TABLET, FILM COATED in 1 BLISTER PACK | 17 Dec, 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:
Purposes pain reliever expectorant nasal decongestant
Purposes pain reliever antihistamine/cough suppressant nasal decongestant
Product Elements:
Harris teeter sinus relief acetaminophen, guaifenesin, phenylephrine hydrochloride, diphenhydramine hydrochloride sinus relief day time acetaminophen, guaifenesin, phenylephrine hydrochloride acetaminophen acetaminophen guaifenesin guaifenesin phenylephrine hydrochloride phenylephrine croscarmellose sodium crospovidone (15 mpa.s at 5%) fd&c yellow no. 6 maltodextrin microcrystalline cellulose polyethylene glycol, unspecified polyvinyl alcohol, unspecified povidone, unspecified silicon dioxide stearic acid talc titanium dioxide l145 sinus relief night time acetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride, acetaminophen acetaminophen diphenhydramine hydrochloride diphenhydramine phenylephrine hydrochloride phenylephrine crospovidone (15 mpa.s at 5%) fd&c blue no. 1 fd&c blue no. 2 magnesium stearate microcrystalline cellulose polyethylene glycol, unspecified polyvinyl alcohol, unspecified povidone, unspecified silicon dioxide stearic acid talc titanium dioxide l27h
Indications and Usage:
Uses ⢠temporarily relieves: ⢠nasal congestion ⢠headache ⢠minor aches and pains ⢠sinus congestion and pressure ⢠runny nose and sneezing (night only) ⢠cough (night only) ⢠temporarily promotes nasal and/or sinus drainage ⢠helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive (day only)
Warnings:
Warnings liver warning: these products contain 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 these products 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. do not use ⢠with any other drug containing acetaminophen (prescription or nonprescription). if you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. ⢠with any other product containing diphenhydramine, even one used on skin (night only) ⢠if you are now 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 kn
Read more...ow if your prescription drug contains an maoi, ask a doctor or pharmacist before taking these products. ⢠if you have ever had an allergic reaction to these products or any of their ingredients ask a doctor before use if you have ⢠liver disease ⢠heart disease ⢠diabetes ⢠high blood pressure ⢠thyroid disease ⢠trouble urinating due to an enlarged prostate gland ⢠glaucoma (night only) ⢠a breathing problem such as emphysema or chronic bronchitis (night only) ⢠persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema ⢠cough that occurs with too much phlegm (mucus) ask a doctor or pharmacist before use if you are ⢠taking the blood thinning drug warfarin ⢠taking sedatives or tranquilizers (night only) when using these products ⢠do not use more than directed ⢠excitability may occur, especially in children (night only) ⢠marked drowsiness may occur (night only) ⢠alcohol, sedatives, and tranquilizers may increase drowsiness (night only) ⢠avoid alcoholic drinks (night only) ⢠be careful when driving a motor vehicle or operating machinery (night only) stop use and ask a doctor if ⢠nervousness, dizziness, or sleeplessness occur ⢠pain, nasal congestion or cough gets worse or lasts more than 7 days ⢠fever gets worse or lasts more than 3 days ⢠redness or swelling is present ⢠new symptoms occur ⢠cough comes back or occurs with rash or headache that lasts. these could be signs of a serious condition. if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. overdose warning: 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.
Do Not Use:
Warnings liver warning: these products contain 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 these products 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. do not use ⢠with any other drug containing acetaminophen (prescription or nonprescription). if you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. ⢠with any other product containing diphenhydramine, even one used on skin (night only) ⢠if you are now 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 prescription drug contains an maoi, ask a doctor or pharmacist before taking these products. ⢠if you have ever had an allergic reaction to these products or any of their ingredients ask a doctor before use if you have ⢠liver disease ⢠heart disease ⢠diabetes ⢠high blood pressure ⢠thyroid disease ⢠trouble urinating due to an enlarged prostate gland ⢠glaucoma (night only) ⢠a breathing problem such as emphysema or chronic bronchitis (night only) ⢠persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema ⢠cough that occurs with too much phlegm (mucus) ask a doctor or pharmacist before use if you are ⢠taking the blood thinning drug warfarin ⢠taking sedatives or tranquilizers (night only) when using these products ⢠do not use more than directed ⢠excitability may occur, especially in children (night only) ⢠marked drowsiness may occur (night only) ⢠alcohol, sedatives, and tranquilizers may increase drowsiness (night only) ⢠avoid alcoholic drinks (night only) ⢠be careful when driving a motor vehicle or operating machinery (night only) stop use and ask a doctor if ⢠nervousness, dizziness, or sleeplessness occur ⢠pain, nasal congestion or cough gets worse or lasts more than 7 days ⢠fever gets worse or lasts more than 3 days ⢠redness or swelling is present ⢠new symptoms occur ⢠cough comes back or occurs with rash or headache that lasts. these could be signs of a serious condition. if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. overdose warning: 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.
When Using:
When using these products ⢠do not use more than directed ⢠excitability may occur, especially in children (night only) ⢠marked drowsiness may occur (night only) ⢠alcohol, sedatives, and tranquilizers may increase drowsiness (night only) ⢠avoid alcoholic drinks (night only) ⢠be careful when driving a motor vehicle or operating machinery (night only)
Dosage and Administration:
Directions ⢠do not take more than directed (see overdose warning) ⢠do not take more than 10 caplets in any 24-hour period ⢠adults and children 12 years of age and older: take 2 caplets every 4 hours ⢠children under 12 years of age: do not use
Stop Use:
Stop use and ask a doctor if ⢠nervousness, dizziness, or sleeplessness occur ⢠pain, nasal congestion or cough gets worse or lasts more than 7 days ⢠fever gets worse or lasts more than 3 days ⢠redness or swelling is present ⢠new symptoms occur ⢠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 convenience pack maximum strength for ages 12+ compare to active ingredients in mucinex ® sinus-max ® sinus relief pain reliever â acetaminophen expectorant â guaifenesin nasal decongestant â phenylephrine hcl day time relieves: sinus pressure headache congestion thins & loosens mucus actual size 10 caplets pain reliever â acetaminophen antihistamine/cough suppressant â diphenhydramine hcl nasal decongestant â phenylephrine hcl night time relieves: nasal congestion sinus pressure & pain runny nose sneezing & cough actual size 10 caplets sinus relief image
Further Questions:
Questions or comments? 1-800-719-9260