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Awake maximum strength - Medication Information

Product NDC Code 36800-844
Drug Name

Awake maximum strength

Type Brand
Pharm Class Central Nervous System Stimulant [EPC],
Central Nervous System Stimulation [PE],
Methylxanthine [EPC],
Xanthines [CS]
Active Ingredients
Caffeine 200 mg/1
Route ORAL
Dosage Form TABLET, FILM COATED
RxCUI drug identifier 198520
Application Number M011
Labeler Name Topco Associates, LLC
Packages
Package NDC Code Description
36800-844-11 1 bottle, plastic in 1 carton (36800-844-11) / 60 tablet, film coated in 1 bottle, plastic
Check if available Online

Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient (in each caplet) Caffeine 200 mg

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
Directions adults and children 12 years and over: take ½ to 1 caplet not more often than every 3 to 4 hours children under 12 years: do not use

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients corn starch, dextrates hydrated, dibasic calcium phosphate dihydrate, flavor, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, stearic acid

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Use helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness

Purpose

Information about the drug product’s indications for use.
Purpose Alertness aid

Spl product data elements

Usually a list of ingredients in a drug product.
Awake Maximum Strength Caffeine CAFFEINE CAFFEINE STARCH, CORN DEXTROSE MONOHYDRATE DIBASIC CALCIUM PHOSPHATE DIHYDRATE HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED STEARIC ACID 44;344

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
Principal display panel TopCare® health NDC 36800-844-11 COMPARE TO MAXIMUM STRENGTH NODOZ® ACTIVE INGREDIENT* MAXIMUM STRENGTH Awake CAFFEINE, 200 mg Alertness Aid • Helps Restore Mental Alertness When Experiencing Fatigue 60 CAPLETS actual size TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING *This product is not manufactured or distributed by Lil’ Drug Store Products, Inc., owner of the registered trademark Maximum Strength NoDoz®. 50844 REV1219B3441 DISTRIBUTED BY TOPCO ASSOCIATES LLC ELK GROVE VILLAGE, IL 60007 © TOPCO LNKA0521 QUESTIONS? 1-888-423-0139 [email protected] www.topcarebrand.com QUALITY GUARANTEED TopCare 44-344 TopCare 44-344

Do not use

Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.
Do not use for children under 12 years of age as a substitute for sleep

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions or comments? 1-888-423-0139

Stop use

Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.
Stop use and ask a doctor if fatigue or drowsiness persists or continues to recur.

Pregnancy or breast feeding

Pregnancy or Breast feeding
If pregnant or breast-feeding, ask a health professional before use.

Storage and handling

Information about safe storage and handling of the drug product.
Other information store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) see end flap for expiration date and lot number

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
Warnings For occasional use only 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 for children under 12 years of age as a substitute for sleep Stop use and ask a doctor if fatigue or drowsiness persists or continues to recur. 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.

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API

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