Comfort-Time description, usages, side effects, indications, overdosage, supplying and lots more!

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Comfort-Time

Time Cap Labs, Inc

Drug Facts




FULL PRESCRIBING INFORMATION

Active ingredient

Active ingredients (in each tablet)



Purpose

Purpose



Uses

Uses
  • for the temporary relief of these symptoms associated with menstrual periods:
    • cramps
    • bloating
    • water-weight gain
    • headache
    • backache
    • breast tenderness
    • fatigue
    • muscle aches
Warnings
Liver warning:

  • more than 8 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 product
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.
Ask a doctor before use if you have
  • difficulty in urination due to enlargement of the prostate gland
  • liver disease
  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
Ask a doctor or pharmacist before use if you are
  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers
When using this product
  • you may get drowsy
  • avoid alcoholic drinks
  • excitability may occur, especially in children
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • 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 heartbeat. The recommended dose of this product contains about as much caffeine as a cup of coffee.
Stop use and ask a doctor if
  • new symptoms occur
  • redness or swelling is present
  • pain gets worse or lasts more than 10 days
If pregnant or breast-feeding,
Keep out of reach of children.
Overdose warning:
Directions
  • do not take more than the recommended dose (see overdose warning)
  • adults and children 12 years and older: take 2 tablets with water. Repeat every 6 hours while symptoms last, as needed. Do not exceed 6 tablets in 24 hours, unless directed by a doctor.
  • children under 12 years: do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage.
Other information
  • store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)
  • use by expiration date on package
Inactive ingredients
Comfort-Time

Comfort-Time

Acetaminophen, Caffeine, and Pyrilamine Maleate TABLET, FILM COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:49483-347
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 500 mg
CAFFEINE 60 mg
PYRILAMINE MALEATE PYRILAMINE 15 mg

Inactive Ingredients

Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
CROSPOVIDONE
HYPROMELLOSE 2910 (6 MPA.S)
HYPROMELLOSE 2910 (15 MPA.S)
MAGNESIUM STEARATE
cellulose, microcrystalline
Mineral Oil
povidone
STARCH, CORN
STEARIC ACID
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
white 17 mm TCL;347 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49483-347-24 24 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 2011-11-30


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Be sure to consult your doctor before taking any medication!
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