Riteaid Nighttime Sleep Aid
Diphenhydramine Hydrochloride And Acetaminophen
Rite Aid Corporation
Human Otc Drug
NDC 11822-8791Riteaid Nighttime Sleep Aid also known as Diphenhydramine Hydrochloride And Acetaminophen is a human otc drug labeled by 'Rite Aid Corporation'. National Drug Code (NDC) number for Riteaid Nighttime Sleep Aid is 11822-8791. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Riteaid Nighttime Sleep Aid drug includes Acetaminophen - 1000 mg/30mL Diphenhydramine Hydrochloride - 50 mg/30mL . The currest status of Riteaid Nighttime Sleep Aid drug is Active.
Drug Information:
| Drug NDC: | 11822-8791 |
| 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: | Riteaid Nighttime Sleep Aid |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Riteaid Nighttime |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | Sleep Aid |
| 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: | Diphenhydramine Hydrochloride And Acetaminophen |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Rite Aid Corporation |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Liquid |
| 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: | ACETAMINOPHEN - 1000 mg/30mL
DIPHENHYDRAMINE HYDROCHLORIDE - 50 mg/30mL
|
| 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 NOT 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 Jun, 2021 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 07 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: | part343 |
| 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: | RITE AID CORPORATION
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1092373
|
| 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: | 0011822129893
|
| UPC stands for Universal Product Code. |
| UNII: | 362O9ITL9D
TC2D6JAD40
|
| 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. |
| Pharmacologic Class: | Histamine H1 Receptor Antagonists [MoA]
Histamine-1 Receptor Antagonist [EPC]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 11822-8791-1 | 354 mL in 1 BOTTLE (11822-8791-1) | 01 Jun, 2021 | 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 pain reliever nighttime sleep-aid
Product Elements:
Riteaid nighttime sleep aid diphenhydramine hydrochloride and acetaminophen acetaminophen acetaminophen diphenhydramine hydrochloride diphenhydramine citric acid monohydrate fd&c blue no. 1 fd&c red no. 40 glycerin potassium citrate propylene glycol water sodium benzoate sorbitol sucralose
Indications and Usage:
Uses ⪠for the temporary relief of occasional minor aches and pains with accompanying sleeplessness.
Warnings:
Warnings liver warning : this product contains acetaminophen. severe liver damage may occur if ⪠adult takes more than 4 doses (30 ml each) in 24 hrs., which is the maximum daily amount for this product ⪠taken 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 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. ⪠for children under 12 years of age ⪠with any other product containing diphenhydramine, even one used on skin. ask a doctor before use if you have ⢠liver disease ⢠a breathing problem such as emphysema or chronic bronchitis ⢠glaucoma ⢠difficult
Read more...y in urination due to enlargement of the prostate gland ask a doctor or pharmacist before use if you are ⢠taking the blood thinning drug warfarin ⢠taking sedatives or tranquilizers when using this product ⢠avoid alcoholic beverages ⢠drowsiness will occur ⢠do not drive a motor vehicle or operate machinery stop use and ask a doctor if ⢠pain gets worse or lasts more than 10 days ⢠fever gets worse or lasts more than 3 days ⢠new symptoms occur ⢠sleeplessness persists continuously for more than 2 weeks. insomnia may be a symptom of serious underlying medical illness. 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 right away at 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 ⪠adult takes more than 4 doses (30 ml each) in 24 hrs., which is the maximum daily amount for this product ⪠taken 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 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. ⪠for children under 12 years of age ⪠with any other product containing diphenhydramine, even one used on skin. ask a doctor before use if you have ⢠liver disease ⢠a breathing problem such as emphysema or chronic bronchitis ⢠glaucoma ⢠difficulty in urination due to enlargement of the prostate gland ask a doctor or pharmacist before use if you are ⢠taking the blood thinning drug warfarin ⢠taking sedatives or tranquilizers when using this product ⢠avoid alcoholic beverages ⢠drowsiness will occur ⢠do not drive a motor vehicle or operate machinery stop use and ask a doctor if ⢠pain gets worse or lasts more than 10 days ⢠fever gets worse or lasts more than 3 days ⢠new symptoms occur ⢠sleeplessness persists continuously for more than 2 weeks. insomnia may be a symptom of serious underlying medical illness. 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 right away at 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 ⢠avoid alcoholic beverages ⢠drowsiness will occur ⢠do not drive a motor vehicle or operate machinery
Dosage and Administration:
Directions ⪠take only one dose (30 ml) per day (24 hours) ⪠only use dose cup provided adults & children 12 yrs & over 30 ml at bedtime children under 12 yrs do not use
Stop Use:
Stop use and ask a doctor if ⢠pain gets worse or lasts more than 10 days ⢠fever gets worse or lasts more than 3 days ⢠new symptoms occur ⢠sleeplessness persists continuously for more than 2 weeks. insomnia may be a symptom of serious underlying medical illness. these could be signs of a serious condition.
Package Label Principal Display Panel:
Principal display panel - 354 ml bottle compare to the active ingredient in vicks® zzzquil⢠night pain sleep-aid* ndc# 11822-8791-1 nighttime sleep-aid pain reliever diphenhydramine hcl acetaminophen ⢠fall asleep fast ⢠max strength pain reliever ⢠non-habit forming berry flavor naturally and artificially flavored no added alcohol 12 fl. oz. (354 ml) *this product is not manufactured or distributed by procter & gamble, the distributor of vicks® zzzquil⢠nigh pain sleep-aid. distributed by: riteaid nighttime sleep aid berry flavor
Further Questions:
Questions or comments? 1-866-467-2748