Daytime Nighttime Cold And Flu
Acetaminophen, Dextromethorphan Hydrobromide, Diphenhydramine Hydrochloride, Guaifenesin, And Phenylephrine Hydrochloride
Heb
Human Otc Drug
NDC 37808-677Daytime Nighttime Cold And Flu also known as Acetaminophen, Dextromethorphan Hydrobromide, Diphenhydramine Hydrochloride, Guaifenesin, And Phenylephrine Hydrochloride is a human otc drug labeled by 'Heb'. National Drug Code (NDC) number for Daytime Nighttime Cold And Flu is 37808-677. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Daytime Nighttime Cold And Flu drug includes . The currest status of Daytime Nighttime Cold And Flu drug is Active.
Drug Information:
| Drug NDC: | 37808-677 |
| 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 Cold And Flu |
| 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 Hydrobromide, Diphenhydramine Hydrochloride, Guaifenesin, And Phenylephrine Hydrochloride |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Heb |
| 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 May, 2021 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 31 Aug, 2023 |
| 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: | 18 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: | HEB
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1046751
1110988
1424551
|
| 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 |
|---|
| 37808-677-03 | 1 KIT in 1 CARTON (37808-677-03) * 10 TABLET, COATED in 1 BLISTER PACK * 10 TABLET, COATED in 1 BLISTER PACK | 31 May, 2021 | 31 Aug, 2023 | 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:
Active ingredients (in each day time caplet) purpose acetaminophen 325 mg pain reliever/fever reducer dextromethorphan hbr 10 mg cough suppressant guaifenesin 200 mg expectorant phenylephrine hcl 5 mg nasal decongestant
Active ingredients (in each night time caplet) purpose acetaminophen 325 mg pain reliever/fever reducer diphenhydramine hcl 25 mg antihistamine phenylephrine hcl 5 mg nasal decongestant
Product Elements:
Daytime nighttime cold and flu acetaminophen, dextromethorphan hydrobromide, diphenhydramine hydrochloride, guaifenesin, and phenylephrine hydrochloride acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride silicon dioxide croscarmellose sodium crospovidone fd&c red no. 40 aluminum oxide fd&c yellow no. 6 magnesium stearate maltodextrin cellulose, microcrystalline polyethylene glycol, unspecified polyvinyl alcohol povidone starch, pregelatinized corn stearic acid talc titanium dioxide acetaminophen acetaminophen dextromethorphan hydrobromide dextromethorphan guaifenesin guaifenesin phenylephrine hydrochloride phenylephrine aaa;1165 acetaminophen, diphenhydramine hyrochloride, phenylephrine hydrochloride acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride silicon dioxide copovidone croscarmellose sodium fd&c blue no. 1 hypromelloses anhydrous lactose magnesium stearate povidone starch, pregelatinized corn propylene glycol sodium starch glycolate type a corn stearic acid titanium dioxide triacetin acetaminophen acetaminophen diphenhydramine hydrochloride diphenhydramine phenylephrine hydrochloride phenylephrine capsule-shaped aaa;1116
Indications and Usage:
Uses temporarily relieves these common cold and flu symptoms: nasal congestion cough (day time severe cold only) minor aches and pains headache sore throat runny nose and sneezing (night time cold & flu only) helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive (day time severe cold only) temporarily reduces fever
Warnings:
Warnings liver warning this product contains acetaminophen. severe liver damage may occur if you take more than 12 caplets in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks daily 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 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 time cold & flu only) if you are now taking a prescription monoamine oxidase inhibitor (maoi) (certain drugs for
Read more... 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 prescription drug contains an maoi, ask a doctor or pharmacist before taking this product. for children under 12 years of age ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland glaucoma (night time cold & flu only) a breathing problem such as emphysema or chronic bronchitis (night time cold & flu only) persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema (day time severe cold only) cough that occurs with too much phlegm (mucus) (day time severe cold only) ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers (night time cold & flu only) when using this product do not use more than directed excitability may occur, especially in children (night time cold & flu only) marked drowsiness may occur (night time cold & flu only) alcohol, sedatives, and tranquilizers may increase drowsiness (night time cold & flu only) avoid alcoholic drinks (night time cold & flu only) be careful when driving a motor vehicle or operating machinery (night time cold & flu 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 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 for adults as well as for children 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 you take more than 12 caplets in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks daily 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 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 time cold & flu only) if you are now 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 prescription drug contains an maoi, ask a doctor or pharmacist before taking this product. for children under 12 years of age ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland glaucoma (night time cold & flu only) a breathing problem such as emphysema or chronic bronchitis (night time cold & flu only) persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema (day time severe cold only) cough that occurs with too much phlegm (mucus) (day time severe cold only) ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers (night time cold & flu only) when using this product do not use more than directed excitability may occur, especially in children (night time cold & flu only) marked drowsiness may occur (night time cold & flu only) alcohol, sedatives, and tranquilizers may increase drowsiness (night time cold & flu only) avoid alcoholic drinks (night time cold & flu only) be careful when driving a motor vehicle or operating machinery (night time cold & flu 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 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 for adults as well as for children even if you do not notice any signs or symptoms.
When Using:
When using this product do not use more than directed excitability may occur, especially in children (night time cold & flu only) marked drowsiness may occur (night time cold & flu only) alcohol, sedatives, and tranquilizers may increase drowsiness (night time cold & flu only) avoid alcoholic drinks (night time cold & flu only) be careful when driving a motor vehicle or operating machinery (night time cold & flu only)
Dosage and Administration:
Directions do not take more than directed (see overdose warning ) do not take day time and night time caplets at the same time do not take more than 12 caplets in any 24-hour period adults and children 12 years 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 heb® ndc 37808-677-03 maximum strength day time cold & flu actaminophen / pain reliever/fever reducer dextromethorphan hbr / cough suppressant guaifenesin / expectorant phenylephrine hcl / nasal decongestant day caplet relieves ⢠headache + body pain ⢠fever + sore throat ⢠cough + chest congestion ⢠nasal congestion day actual size 20 caplets night time cold & flu actaminophen / pain reliever/fever reducer diphenhydramine hcl / antihistamine phenylephrine hcl / nasal decongestant night caplet relieves ⢠headache + body pain ⢠fever + sore throat ⢠nasal congestion ⢠sneezing ⢠runny nose for ages 12+ night actual size 10 caplets image description
Further Questions:
Questions or comments? 1-844-705-4384