COMFORT-TIME- acetaminophen, caffeine, and pyrilamine maleate tablet, film coated

Comfort-Time by

Drug Labeling and Warnings

Comfort-Time by is a Otc medication manufactured, distributed, or labeled by Time Cap Labs, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INDICATIONS & USAGE

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 DOCTOR

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 DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin
taking sedatives or tranquilizers

WHEN USING

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

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.

OVERDOSAGE

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

DOSAGE & ADMINISTRATION

Uses

for the temporary relief of these symptoms associated with menstrual periods:

cramps
bloating
water-weight gain
headache
backache
breast tenderness
fatigue
muscle aches

STORAGE AND HANDLING

Other information

store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)
use by expiration date on package

INACTIVE INGREDIENT

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, povidone, pregelatinized starch, stearic acid, titanium dioxide

tcl blister 24 tablets

INGREDIENTS AND APPEARANCE

COMFORT-TIME 
acetaminophen, caffeine, and pyrilamine maleate tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49483-347
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)	CAFFEINE	60 mg
PYRILAMINE MALEATE (UNII: R35D29L3ZA) (PYRILAMINE - UNII:HPE317O9TL)	PYRILAMINE MALEATE	15 mg

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
CROSPOVIDONE (UNII: 68401960MK)
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
MINERAL OIL (UNII: T5L8T28FGP)
POVIDONE (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	white	Score	no score
Shape	CAPSULE	Size	17mm
Flavor		Imprint Code	TCL;347
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49483-347-24	24 in 1 BLISTER PACK; Type 0: Not a Combination Product	12/14/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	11/30/2011

Labeler - Time Cap Labs, Inc (037052099)

Establishment
Name	Address	ID/FEI	Business Operations
Time Cap Labs, Inc		037052099	manufacture(49483-347)