2. Drugs
  3. Human OTC Drug
  4. Daytime Nighttime

Daytime Nighttime

Acetaminophen, Dextromethorphan Hbr, Phenylephrine Hcl And Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate


H-e-b
Human Otc Drug
NDC 37808-191
Daytime Nighttime also known as Acetaminophen, Dextromethorphan Hbr, Phenylephrine Hcl And Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate is a human otc drug labeled by 'H-e-b'. National Drug Code (NDC) number for Daytime Nighttime is 37808-191. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Daytime Nighttime drug includes . The currest status of Daytime Nighttime drug is Active.

Drug Information:

Drug NDC: 37808-191
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
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, Phenylephrine Hcl And Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: H-e-b
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: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: 20 Jun, 2022
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 06 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:H-E-B
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:1086997
1094549
1311150
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 NDCDescriptionMarketing Start DateMarketing End DateSample Available
37808-191-484 BLISTER PACK in 1 CARTON (37808-191-48) / 1 KIT in 1 BLISTER PACK * 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK * 4 CAPSULE, LIQUID FILLED in 1 BLISTER PACK20 Jun, 2022N/ANo
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.
Other medicines with the same generic name

Daytime Nighttime Cold And Flu


Acetaminophen & more..

Kit
WALGREENS
NDC: 0363-0729

Daytime Nighttime


Acetaminophen & more..

Kit
H-E-B
NDC: 37808-191

Purpose:

Purpose pain reliever/fever reducer cough suppressant nasal decongestant

Purpose pain reliever/fever reducer cough suppressant antihistamine

Product Elements:

Daytime nighttime acetaminophen, dextromethorphan hbr, phenylephrine hcl and acetaminophen, dextromethorphan hbr, doxylamine succinate daytime acetaminophen, dextromethorphan hbr, phenylephrine hcl fd&c yellow no. 6 fd&c red no. 40 polyethylene glycol, unspecified povidone sorbitan titanium dioxide shellac water gelatin glycerin propylene glycol acetaminophen acetaminophen dextromethorphan hydrobromide dextromethorphan phenylephrine hydrochloride phenylephrine oblong shaped 70 nightime acetaminophen dextromethorphan hbr doxylamine succinate fd&c blue no. 1 gelatin povidone water polyethylene glycol, unspecified shellac titanium dioxide propylene glycol sorbitan d&c yellow no. 10 glycerin dextromethorphan hydrobromide dextromethorphan acetaminophen acetaminophen doxylamine succinate doxylamine oblong shaped 71

Indications and Usage:

Uses temporarily relieves common cold/flu symptoms: • nasal congestion • cough due to minor throat & bronchial irritation • sore throat • headache • minor aches & pains • fever

Uses temporarily relieves common cold/flu symptoms: • cough due to minor throat & bronchial irritation • sore throat • headache • minor aches & pains • fever • runny nose & sneezing

Warnings:

Warnings liver warning: this product contains acetaminophen. severe liver damage may occur if you take more than 4 doses in 24 hrs, which is the maximum daily amount for this product 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, lasts 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. • 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. ask a doctor before use if you have • liver disease • heart disease • high blood pressure • thyroid disease • diabetes • trouble urinating due to enlarged prostate gland • cough that occurs with too much phlegm (mucus) • persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin. when using this product, do not use more than directed stop use and ask a doctor if • you get nervous, dizzy or sleepless • pain, nasal congestion or cough get 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. in case of overdose, get medical help or contact a poison control center righl away (1-800-222-1222). quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms.

Warnings liver warning: this product contains acetaminophen. severe liver damage may occur if you take • more than 4 doses in 24 hrs, which is the maximum daily amount for this product • 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, lasts 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. • if you are now taking a prescription monoamine oxidase inhibitor (maoi) (certain drugs for depression, psychiatric or emotion
al 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. ask a doctor before use if you have • liver disease • glaucoma • cough that occurs with too much phlegm (mucus) • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema • trouble urinating due to enlarged prostrate gland ask a doctor or pharmacist before use if you are • taking sedatives or tranquilizers • taking the blood thinning drug warfarin when using this product • excitability may occur, especially in children • marked drowsiness may occur • avoid alcoholic drinks • be careful when driving a motor vehicle or operating machinery • alcohol, sedatives, & tranquilizers may increase drowsiness stop use and ask a doctor if • pain, 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 breastfeeding, ask a health professional before use. keep out of reach of children. in case of overdose, get medical help or contact a poison control center (1-800-222-1222) right away. quick medical attention is critical for adults & 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 4 doses in 24 hrs, which is the maximum daily amount for this product 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, lasts 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. • 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. ask a doctor before use if you have • liver disease • heart disease • high blood pressure • thyroid disease • diabetes • trouble urinating due to enlarged prostate gland • cough that occurs with too much phlegm (mucus) • persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin. when using this product, do not use more than directed stop use and ask a doctor if • you get nervous, dizzy or sleepless • pain, nasal congestion or cough get 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. in case of overdose, get medical help or contact a poison control center righl away (1-800-222-1222). quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms.

Warnings liver warning: this product contains acetaminophen. severe liver damage may occur if you take • more than 4 doses in 24 hrs, which is the maximum daily amount for this product • 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, lasts 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. • 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. ask a doctor before use if you have • liver disease • glaucoma • cough that occurs with too much phlegm (mucus) • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema • trouble urinating due to enlarged prostrate gland ask a doctor or pharmacist before use if you are • taking sedatives or tranquilizers • taking the blood thinning drug warfarin when using this product • excitability may occur, especially in children • marked drowsiness may occur • avoid alcoholic drinks • be careful when driving a motor vehicle or operating machinery • alcohol, sedatives, & tranquilizers may increase drowsiness stop use and ask a doctor if • pain, 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 breastfeeding, ask a health professional before use. keep out of reach of children. in case of overdose, get medical help or contact a poison control center (1-800-222-1222) right away. quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms.

When Using:

When using this product, do not use more than directed

When using this product • excitability may occur, especially in children • marked drowsiness may occur • avoid alcoholic drinks • be careful when driving a motor vehicle or operating machinery • alcohol, sedatives, & tranquilizers may increase drowsiness

Dosage and Administration:

Directions take only as directed do not exceed 4 doses per 24 hrs adults & children 12yrs & over: 2 softgels with water every 4 hrs children 4 to under 12 yrs: ask a doctor children under 4 yrs: do not use

Directions • take only as directed • do not exceed 4 doses per 24 hrs adults & children 12 yrs & over: 2 softgels with water every 6 hrs children 4 to under 12 yrs: ask a doctor children under 4 yrs: do not use

Stop Use:

Stop use and ask a doctor if • you get nervous, dizzy or sleepless • pain, nasal congestion or cough get 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.

Stop use and ask a doctor if • pain, 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:

695t-heb-daytimenighttime-48s

Further Questions:

Questions? call 1-877-290-4008

Questions? call 1-877-290-4008


Comments/ Reviews:

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