NDC 69842-037 Acetaminophen
Acetaminophen
NDC Product Code 69842-037
Proprietary Name: Acetaminophen What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name: Acetaminophen What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Drug Use Information
Drug Use InformationThe drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.
- This drug is used to treat mild to moderate pain (from headaches, menstrual periods, toothaches, backaches, osteoarthritis, or cold/flu aches and pains) and to reduce fever.
Product Characteristics
Color(s):
WHITE (C48325 - WHITE TO OFF-WHITE)
Shape: CAPSULE (C48336)
Size(s):
19 MM
Imprint(s):
I;06
Score: 1
NDC Code Structure
- 69842 - Cvs Pharmacy, Inc.
- 69842-037 - Acetaminophen
NDC 69842-037-35
Package Description: 225 TABLET, EXTENDED RELEASE in 1 BOTTLE
NDC 69842-037-44
Package Description: 400 TABLET, EXTENDED RELEASE in 1 BOTTLE
NDC 69842-037-91
Package Description: 1 BOTTLE in 1 CARTON > 150 TABLET, EXTENDED RELEASE in 1 BOTTLE
NDC Product Information
Acetaminophen with NDC 69842-037 is a a human over the counter drug product labeled by Cvs Pharmacy, Inc.. The generic name of Acetaminophen is acetaminophen. The product's dosage form is tablet, extended release and is administered via oral form.
Labeler Name: Cvs Pharmacy, Inc.
Dosage Form: Tablet, Extended Release - A solid dosage form containing a drug which allows at least a reduction in dosing frequency as compared to that drug presented in conventional dosage form.
Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
Acetaminophen Active Ingredient(s)
What is the Active Ingredient(s) List?This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Inactive Ingredient(s)
About the Inactive Ingredient(s)The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.
- SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
- HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) (UNII: 8136Y38GY5)
- HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
- MAGNESIUM STEARATE (UNII: 70097M6I30)
- MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
- POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
- STARCH, CORN (UNII: O8232NY3SJ)
- SODIUM STARCH GLYCOLATE TYPE B POTATO (UNII: 27NA468985)
- TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
- TRIACETIN (UNII: XHX3C3X673)
Administration Route(s)
What are the Administration Route(s)?The translation of the route code submitted by the firm, indicating route of administration.
- Oral - Administration to or by way of the mouth.
Product Labeler Information
What is the Labeler Name?Name of Company corresponding to the labeler code segment of the Product NDC.
Labeler Name: Cvs Pharmacy, Inc.
Labeler Code: 69842
FDA Application Number: ANDA207229 What is the FDA Application Number?
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.
Marketing Category: ANDA - A product marketed under an approved Abbreviated New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.
Start Marketing Date: 12-23-2020 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
Listing Expiration Date: 12-31-2022 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.
Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.
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Information for Patients
Diphenhydramine
Diphenhydramine is pronounced as (dye fen hye' dra meen)
Why is diphenhydramine medication prescribed?
Diphenhydramine is used to relieve red, irritated, itchy, watery eyes; sneezing; and runny nose caused by hay fever, allergies, or the common cold. Diphenhydramine is als...
[Read More]
* Please review the disclaimer below.
Acetaminophen Product Labeling Information
The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
Product Labeling Index
- Drug Facts
- Purpose
- Uses
- Warnings
- Do Not Use
- Stop Use And Ask A Doctor If
- Keep Out Of Reach Of Children.
- Directions
- Other Information
- Inactive Ingredients
Drug Facts
Active ingredient (in each extended-release tablet) Acetaminophen USP 650 mg
Purpose
Pain reliever/fever reducer
Uses
- Temporarily relieves minor aches and pains due to:minor pain of arthritis muscular achesbackachepremenstrual and menstrual crampsthe common coldheadache toothachetemporarily reduces fever
Warnings
- Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 6 tablets in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this productAllergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:skin reddeningblistersrashIf 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.if you are allergic to acetaminophen or any of the inactive ingredients in this product.Ask a doctor before use if you have liver disease. Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin
Stop Use And Ask A Doctor If
- Pain gets worse or lasts more than 10 daysfever gets worse or lasts more than 3 days new symptoms occurredness or swelling is present 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.
Directions
- Do not take more than directed (see overdose warning).Adults:take 2 tablets every 8 hours with water swallow whole; do not crush, chew, split or dissolvedo not take more than 6 tablets in 24 hoursdo not use for more than 10 days unless directed by a doctor.Under 18 years of age:ask a doctor
Other Information
- Store at 20o to 25oC (68o to 77oF). Avoid excessive heat 40oC (104oF). do not use if carton is opened or foil inner seal is brokenUSP Dissolution test is pending
Inactive Ingredients
Colloidal silicon dioxide, hydroxyethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch (maize), sodium starch glycolate, titanium dioxide, triacetin Questions or comments? call 1-855-274-4122 Distributed by: CVS Pharmacy, Inc.One CVS Drive, Woonsocket, Rl 02895 ©2021 CVS/pharmacy CVS.com® 1-800-SHOP CVS Made in India Code: TS/DRUGS/22/2009
* Please review the disclaimer below.