Comfort-Time
Acetaminophen, Caffeine, and Pyrilamine Maleate · Tablet, Film Coated · Oral
Active ingredient
active ingredients (in each tablet) Acetaminophen 500 mg Caffeine 60 mg Pyrilamine maleate 15 mg
Purpose
active ingredients (in each tablet) Acetaminophen 500 mg Caffeine 60 mg Pyrilamine maleate 15 mg
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
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
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
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
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers
When using this product
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
Stop use and ask a doctor if new symptoms occur redness or swelling is present pain gets worse or lasts more than 10 days
Pregnancy or breast-feeding
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children
Keep out of reach of children.
Directions
Uses for the temporary relief of these symptoms associated with menstrual periods: cramps bloating water-weight gain headache backache breast tenderness fatigue muscle aches
Other information
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
Inactive ingredients colloidal silicon dioxide, croscarmellose sodium, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, povidone, pregelatinized starch, stearic acid, titanium dioxide
Label text from the FDA structured product label by Time Cap Labs, Inc (revised Dec 14, 2018). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Acetaminophen in 1 product
- Caffeine in 1 product
- Pyrilamine Maleate in 1 product
Comfort-Time NDC products (1)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 49483-347 | Acetaminophen 500 mg/1; Caffeine 60 mg/1; Pyrilamine Maleate 15 mg/1 Tablet, Film Coated | Time Cap Labs, Inc | OTC MONOGRAPH NOT FINAL |
Frequently asked questions
What is Comfort-Time used for?
Uses for the temporary relief of these symptoms associated with menstrual periods: cramps bloating water-weight gain headache backache breast tenderness fatigue muscle aches
Who makes Comfort-Time?
Comfort-Time is listed by 1 labeler in the FDA NDC directory, including Time Cap Labs, Inc.