COMFORT-TIME- acetaminophen, caffeine, and pyrilamine maleate tablet, film coated 
Time Cap Labs, Inc

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.

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TCL COMFORT TIME 347R

active ingredients (in each tablet)


Acetaminophen 500 mg

Caffeine 60 mg

Pyrilamine maleate 15 mg

active ingredients (in each tablet)


Acetaminophen 500 mg

Caffeine 60 mg

Pyrilamine maleate 15 mg

Uses

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

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

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.

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

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

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

tcl blister 24 tablets

IMAGE OF CARTON

COMFORT-TIME 
acetaminophen, caffeine, and pyrilamine maleate tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49483-347
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE60 mg
PYRILAMINE MALEATE (UNII: R35D29L3ZA) (PYRILAMINE - UNII:HPE317O9TL) PYRILAMINE MALEATE15 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorwhiteScoreno score
ShapeCAPSULESize17mm
FlavorImprint Code TCL;347
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49483-347-2424 in 1 BLISTER PACK; Type 0: Not a Combination Product12/14/2018
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/FEIBusiness Operations
Time Cap Labs, Inc037052099manufacture(49483-347)

Revised: 12/2018
Document Id: 7cfef4a4-ab1d-2dd4-e053-2991aa0a56c5
Set id: e94a26a2-36e5-4e1e-aea1-24e035c98043
Version: 3
Effective Time: 20181214
 
Time Cap Labs, Inc