NDC 62011-0238 Pain Reliever Rapid Release
Acetaminophen
NDC Product Code 62011-0238
Proprietary Name: Pain Reliever Rapid Release 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):
GRAY (C48324 - RED AND LIGHT BLUE ENDS)
Shape: OVAL (C48345)
Size(s):
19 MM
Imprint(s):
G1
Score: 1
NDC Code Structure
- 62011 - Strategic Sourcing Services Llc
- 62011-0238 - Pain Reliever Rapid Release
NDC 62011-0238-1
Package Description: 1 BOTTLE, PLASTIC in 1 CARTON > 100 TABLET, COATED in 1 BOTTLE, PLASTIC
NDC 62011-0238-2
Package Description: 1 BOTTLE, PLASTIC in 1 CARTON > 24 TABLET, COATED in 1 BOTTLE, PLASTIC
NDC Product Information
Pain Reliever Rapid Release with NDC 62011-0238 is a a human over the counter drug product labeled by Strategic Sourcing Services Llc. The generic name of Pain Reliever Rapid Release is acetaminophen. The product's dosage form is tablet, coated and is administered via oral form.
Labeler Name: Strategic Sourcing Services Llc
Dosage Form: Tablet, Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is covered with a designated coating.
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.
Pain Reliever Rapid Release 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)
- CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
- D&C RED NO. 33 (UNII: 9DBA0SBB0L)
- FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
- FD&C RED NO. 40 (UNII: WZB9127XOA)
- FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
- GELATIN (UNII: 2G86QN327L)
- HYDROXYPROPYL CELLULOSE (TYPE H) (UNII: RFW2ET671P)
- HYPROMELLOSES (UNII: 3NXW29V3WO)
- FERROSOFERRIC OXIDE (UNII: XM0M87F357)
- FERRIC OXIDE RED (UNII: 1K09F3G675)
- FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
- POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
- POVIDONES (UNII: FZ989GH94E)
- STARCH, CORN (UNII: O8232NY3SJ)
- STEARIC ACID (UNII: 4ELV7Z65AP)
- TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
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: Strategic Sourcing Services Llc
Labeler Code: 62011
FDA Application Number: part343 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: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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: 10-24-2014 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: 12-31-2021 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
Acetaminophen
Acetaminophen is pronounced as (a set a mee' noe fen)
Why is acetaminophen medication prescribed?
Acetaminophen is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to va...
[Read More]
* Please review the disclaimer below.
Pain Reliever Rapid Release Product Label Images
Pain Reliever Rapid Release 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
- Other
- Active Ingredient (In Each Gelcap)
- Purpose
- Uses
- Liver Warning
- Allergy Alert
- Do Not Use
- Otc - Ask Doctor
- Otc - Ask Doctor/Pharmacist
- Stop Use And Ask A Doctor If
- Otc - Pregnancy Or Breast Feeding
- Otc - Keep Out Of Reach Of Children
- Overdose Warning
- Directions
- Other Information
- Inactive Ingredients
Other
Drug Facts
Active Ingredient (In Each Gelcap)
Acetaminophen 500 mg
Purpose
Pain reliever/fever reducer
Uses
- Temporarily relieves minor aches and pains due to:
- The common coldheadachebackacheminor pain of arthritistoothachemuscular achespremenstrual and menstrual crampstemporarily reduces fever
Liver Warning
- This product contains acetaminophen. Severe liver damage may occur if you takemore than 4,000 mg of acetaminophen in 24 hourswith other drugs containing acetaminophen3 or more alcoholic drinks every day while using this product
Allergy 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
Otc - Ask Doctor
Ask a doctor before use if you have liver disease.
Otc - Ask Doctor/Pharmacist
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 daysnew symptoms occurredness or swelling is presentThese could be signs of a serious condition.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
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 and children 12 years and overtake 2 gelcaps every 6 hours while symptoms lastdo not take more than 6 gelcaps in 24 hours, unless directed by a doctordo not use for more than 10 days unless directed by a doctorchildren under 12 yearsask a doctor
Other Information
- Store between 20-25ºC (68-77ºF)retain carton for complete product information
Inactive Ingredients
Colloidal silicon dioxide, croscarmellose sodium, D&C red #33, edible ink, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide
* Please review the disclaimer below.