Tcl Comfort Time 347r

SPL v3

SPL

SPL Set ID e94a26a2-36e5-4e1e-aea1-24e035c98043

Route

ORAL

Published

Effective Date 2011-11-30

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (500 mg) Caffeine (60 mg) Pyrilamine (15 mg)

Inactive Ingredients

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

Identifiers & Packaging

Pill Appearance

Imprint: TCL;347 Shape: capsule Color: white Size: 17 mm Score: 1

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2011-11-30

Description

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

Medication Information

Warnings and Precautions

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

Indications and 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

Dosage and 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

Description

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

Section 34088-5

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

Section 44425-7

Other information

store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)

use by expiration date on package

Section 50565-1

Keep out of reach of children.

Section 50566-9

Stop use and ask a doctor if

new symptoms occur

redness or swelling is present

pain gets worse or lasts more than 10 days

Section 50567-7

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.

Section 50568-5

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin

taking sedatives or tranquilizers

Section 50569-3

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

Section 50570-1

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.

Section 51727-6

Inactive ingredients

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

Section 53414-9

If pregnant or breast-feeding,

ask a health professional before use.

Section 55105-1

active ingredients (in each tablet)

Acetaminophen 500 mg

Caffeine 60 mg

Pyrilamine maleate 15 mg

Section 55106-9

active ingredients (in each tablet)

Acetaminophen 500 mg

Caffeine 60 mg

Pyrilamine maleate 15 mg

Tcl Blister 24 Tablets

Structured Label Content

Indications and Usage (34067-9)

Uses

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

cramps

bloating

water-weight gain

headache

backache

breast tenderness

fatigue

muscle aches

Dosage and Administration (34068-7)

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 and Precautions (34071-1)

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

Section 34088-5 (34088-5)

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

Section 44425-7 (44425-7)

Other information

store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)

use by expiration date on package

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

new symptoms occur

redness or swelling is present

pain gets worse or lasts more than 10 days

Section 50567-7 (50567-7)

When using this product

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin

taking sedatives or tranquilizers

Section 50569-3 (50569-3)

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

Section 50570-1 (50570-1)

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.

Section 51727-6 (51727-6)

Inactive ingredients

Section 53414-9 (53414-9)

If pregnant or breast-feeding,

ask a health professional before use.

Section 55105-1 (55105-1)

active ingredients (in each tablet)

Acetaminophen 500 mg

Caffeine 60 mg

Pyrilamine maleate 15 mg

Section 55106-9 (55106-9)

active ingredients (in each tablet)

Acetaminophen 500 mg

Caffeine 60 mg

Pyrilamine maleate 15 mg

Tcl Blister 24 Tablets (tcl blister 24 tablets)

Advanced Ingredient Data

[{"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CROSCARMELLOSE SODIUM", "unii": "M28OL1HH48", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CROSPOVIDONE", "unii": "68401960MK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSE 2910 (6 MPA.S)", "unii": "0WZ8WG20P6", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSE 2910 (15 MPA.S)", "unii": "36SFW2JZ0W", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CELLULOSE, MICROCRYSTALLINE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MINERAL OIL", "unii": "T5L8T28FGP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POVIDONE", "unii": "FZ989GH94E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STEARIC ACID", "unii": "4ELV7Z65AP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ACETAMINOPHEN", "unii": "362O9ITL9D", "classCode": "ACTIB", "strengthNumerator": "500", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "CAFFEINE", "unii": "3G6A5W338E", "classCode": "ACTIB", "strengthNumerator": "60", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "PYRILAMINE", "unii": "HPE317O9TL", "classCode": "ACTIB", "strengthNumerator": "15", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Uses for the temporary relief of these symptoms associated with menstrual periods: cramps bloating water-weight gain headache backache breast tenderness fatigue muscle aches", "34068-7": "Uses for the temporary relief of these symptoms associated with menstrual periods: cramps bloating water-weight gain headache backache breast tenderness fatigue muscle aches", "34071-1": "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", "34088-5": "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", "44425-7": "Other information store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F) use by expiration date on package", "50565-1": "Keep out of reach of children.", "50566-9": "Stop use and ask a doctor if new symptoms occur redness or swelling is present pain gets worse or lasts more than 10 days", "50567-7": "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.", "50568-5": "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers", "50569-3": "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", "50570-1": "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.", "51727-6": "Inactive ingredients colloidal silicon dioxide, croscarmellose sodium, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, povidone, pregelatinized starch, stearic acid, titanium dioxide", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "55105-1": "active ingredients (in each tablet) Acetaminophen 500 mg Caffeine 60 mg Pyrilamine maleate 15 mg", "55106-9": "active ingredients (in each tablet) Acetaminophen 500 mg Caffeine 60 mg Pyrilamine maleate 15 mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:42.545625 · Updated: 2026-03-14T22:55:22.018235