NDC 62207-680 Acetaminophen, Aspirin And Caffeine

Acetaminophen, Aspirin And Caffeine

NDC Product Code 62207-680

NDC CODE: 62207-680

Proprietary Name: Acetaminophen, Aspirin And Caffeine 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, Aspirin And Caffeine 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.

Product Characteristics

Color(s):
WHITE (C48325)
Shape: CAPSULE (C48336)
Size(s):
17 MM
Imprint(s):
I1
Score: 1

NDC Code Structure

NDC 62207-680-47

Package Description: 500 TABLET in 1 BOTTLE

NDC 62207-680-51

Package Description: 1 BOTTLE in 1 CARTON > 10 TABLET in 1 BOTTLE

NDC 62207-680-98

Package Description: 22500 TABLET in 1 BOX

NDC 62207-680-99

Package Description: 4500 TABLET in 1 POUCH

NDC Product Information

Acetaminophen, Aspirin And Caffeine with NDC 62207-680 is a a human over the counter drug product labeled by Granules India Ltd. The generic name of Acetaminophen, Aspirin And Caffeine is acetaminophen, aspirin and caffeine. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Granules India Ltd

Dosage Form: Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.

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, Aspirin And Caffeine 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.

  • ACETAMINOPHEN 250 mg/1
  • ASPIRIN 250 mg/1
  • CAFFEINE 65 mg/1

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.

  • SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • CARNAUBA WAX (UNII: R12CBM0EIZ)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • HYDROXYPROPYL CELLULOSE (110000 WAMW) (UNII: 5Y0974F5PW)
  • HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)

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: Granules India Ltd
Labeler Code: 62207
FDA Application Number: ANDA214039 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: 04-15-2021 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Acetaminophen, Aspirin And Caffeine 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

Active Ingredient(S)

Acetaminophen 250 mg

Aspirin 250 mg (NSAID*)

Caffeine 65 mg

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Pain reliever

Pain reliever aid

Use(S)

  • Treats migraine

Warnings

Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness.
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.
Allergy alert: Aspirin may cause a severe allergic reaction which may include:

• hives

• facial swelling

• asthma (wheezing)

• shock
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

• more than 2 caplets in 24 hours, which is the maximum daily amount

• with other drugs containing acetaminophen

• 3 or more alcoholic drinks every day while using this product
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you

• are age 60 or older

• have had stomach ulcers or bleeding problems

• take a blood thinning (anticoagulant) or steroid drug

• take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)

• have 3 or more alcoholic drinks every day while using this product

• take more or for a longer time than directed
Medication overuse headache warning: Headaches may worsen if this product is used for 10 or more days per month
Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heart beat.

Do Not Use

• if you have ever had an allergic reaction to acetaminophen, aspirin or any other pain reliever/fever reducer

• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist

Ask A Doctor Before Use If

• you have never had migraines diagnosed by a health professional

• you have a headache that is different from your usual migraines

• you have the worst headache of your life

• you have fever and stiff neck

• you have headaches beginning after or caused by head injury, exertion, coughing or bending

• you experienced your first headache after the age of 50

• you have daily headaches

• you have a migraine so severe as to require bed rest

• you have liver disease

• stomach bleeding warning applies to you

• you have a history of stomach problems, such as heartburn

• you have high blood pressure, heart disease, liver cirrhosis, or kidney disease

• you are taking a diuretic

• you have asthma

• you have problems or serious side effects from taking pain relievers or fever reducers

• you have vomiting with your migraine headache

Ask A Doctor Or Pharmacist Before Use If

• taking a prescription drug for:

o diabetes

o gout

o arthritis

• under a doctor’s care for any serious condition

• taking any other drug

• taking any other product that contains aspirin, acetaminophen, or any other pain reliever/fever reducer

Stop Use And Ask Doctor If

• an allergic reaction occurs. Seek medical help right away.

• you experience any of the following signs of stomach bleeding :

o feel faint

o vomit blood

o have bloody or black stools

o have stomach pain that does not get better

• your migraine is not relieved or worsens after first dose

• new or unexpected symptoms occur

• ringing in the ears or loss of hearing occurs

If Pregnant Or Breast Feeding

Ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep Out Of Reach Of Children

In case of overdose, get medical help or contact a Poison Control Center right away. 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 use more than directed
• adults: take 2 caplets with a glass of water

• if symptoms persist or worsen, ask your doctor

• do not take more than 2 caplets in 24 hours, unless directed by a doctor

• under 18 years of age: ask a doctor

Other Information

• store at controlled room temperature 20° to 25°C (68° to 77°F)

• close cap tightly after use

• read all product information before using. Keep this box for important information.
• Tamper Evident : Do not use if foil inner seal under the cap is opened or missing

Inactive Ingredients

Carnauba wax, hydroxypropyl cellulose, hypromellose, microcrystalline cellulose, propylene glycol, sodium stearyl fumarate and titanium dioxide

* Please review the disclaimer below.