NDC 70000-0409 Caffeine

Caffeine

NDC Product Code 70000-0409

NDC Code: 70000-0409

Proprietary Name: 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: 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):
YELLOW (C48330)
Shape: ROUND (C48348)
Size(s):
11 MM
Imprint(s):
212;212
Score: 1

NDC Code Structure

  • 70000 - Cardinal Health
    • 70000-0409 - Caffeine

NDC 70000-0409-1

Package Description: 2 BLISTER PACK in 1 CARTON > 8 TABLET in 1 BLISTER PACK

NDC Product Information

Caffeine with NDC 70000-0409 is a a human over the counter drug product labeled by Cardinal Health. The generic name of Caffeine is caffeine. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Cardinal Health

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.

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.

  • CAFFEINE 200 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.

  • CROSCARMELLOSE (UNII: 029TFK992N)
  • DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
  • D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
  • FOOD YELLOW 3 FREE ACID (UNII: G2B7JWK1GG)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

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: Cardinal Health
Labeler Code: 70000
FDA Application Number: part340 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 FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 04-05-2019 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: 12-31-2020 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’.

* Please review the disclaimer below.

Caffeine Product Label Images

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

Drug Facts

Active ingredient (in each tablet)Caffeine 200 mg

Otc - Purpose

PurposeAlertness aid

Uses

Helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness

Warnings

For occasional use only

Otc - Do Not Use

Do not use■ in children under 12 years of age■ as a substitute for sleep

Otc - When Using

When using this product limit the use of caffeine-containing medications, foods, or beverages because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat. The recommended dose of this product contains about as much caffeine as a cup of coffee.

Otc - Stop Use

Stop use and ask a doctor if fatigue or drowsiness persists or continues to recur.

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.

Overdosage

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions


adults and children 12 years of age and over: take 1 tablet not more often than every 3 to 4 hours

Other Information


each tablet contains: calcium 62 mg
■ store at room temperature 20-25°C (68°-77°F)■ avoid excessive heat (greater than 100°F) or humidity

Inactive Ingredient

Corn starch, croscarmellose sodium, D&C yellow #10 aluminum lake, dicalcium phosphate, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, silica

Other

RETAIN CARTON FOR COMPLETE PRODUCT INFORMATIONTAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING*This product is not manufactured or distributed by Meda Consumer Healthcare Inc., owner of the registered trademark Vivarin®.Dist. by CAH, Dublin, OH 43017©2019 Cardinal Health100% Money Back GuaranteeReturn to place of purchase if not satisfied

* Please review the disclaimer below.

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