Comfort-Time

Dosage form: tablet, film coated
Ingredients: ACETAMINOPHEN 500mg, CAFFEINE 60mg, PYRILAMINE MALEATE 15mg
Labeler: Time Cap Labs, Inc
NDC Code: 49483-347

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Active ingredients (in each tablet)
Acetaminophen 500 mg
Caffeine 60 mg
Pyrilamine maleate 15 mg

Purpose
Pain reliever
Stimulant
Diuretic

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:
This product contains acetaminophen. Severe liver damage may occur if you take:
  • 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, ask a health professional before use.

Keep out of reach of children.

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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 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 colloidal silicon dioxide, croscarmellose sodium, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, povidone, pregelatinized starch, stearic acid, titanium dioxide

COMFORT-TIME 
acetaminophen, caffeine, and pyrilamine maleate tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49483-347
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
CAFFEINE (CAFFEINE) CAFFEINE60 mg
PYRILAMINE MALEATE (PYRILAMINE) PYRILAMINE MALEATE15 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorwhiteScoreno score
ShapeCAPSULESize17mm
FlavorImprint CodeTCL;347
Contains    
Packaging
#Item CodePackage Description
1NDC:49483-347-2424 TABLET, FILM COATED (TABLET) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34311/30/2011
Labeler - Time Cap Labs, Inc (037052099)
Establishment
NameAddressID/FEIOperations
Time Cap Labs, Inc037052099manufacture

Revised: 11/2011
 
Time Cap Labs, Inc

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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