Timely Tension Headache Relief

Timely Tension Headache Relief
SPL v3
SPL
SPL Set ID 05364eb4-07a1-a4d9-e063-6294a90a47e5
Route
ORAL
Published
Effective Date 2023-09-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg) Caffeine (65 mg)
Inactive Ingredients
D&c Red No. 27 Aluminum Lake Fd&c Yellow No. 6 Aluminum Lake Povidone Fd&c Blue No. 2 Aluminum Lake Starch, Corn Carnauba Wax Talc Polyethylene Glycol, Unspecified Stearic Acid Hypromellose, Unspecified Silicon Dioxide Sodium Starch Glycolate Type A Corn Microcrystalline Cellulose Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: TCL373 Shape: capsule Color: red Size: 18 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-06-16

Description

Active ingredients (in each caplet) Acetaminophen 500 mg Caffeine 65 mg


Medication Information

Warnings and Precautions

Warnings

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stop use and seek medical help right away.

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 6 caplets 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

Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. 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.

Indications and Usage

Uses

Temporarily relieves minor aches and pains due to:

  • headache
  • muscular aches
Dosage and Administration

Directions

  • do not use more than directed
  • adults and children 12 years and over: take 2 caplets every 6 hours; not more than 6 caplets in 24 hours
  • children under 12 years: ask a doctor
Description

Active ingredients (in each caplet) Acetaminophen 500 mg Caffeine 65 mg

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.

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 50566-9

Stop use and ask a doctor if

  • any new symptoms occur
  • painful area is red or swollen
  • pain gets worse or lasts for more than 10 days
  • fever gets worse or lasts for more than 3 days

These could be signs of a serious condition.

Section 50568-5

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin
Section 50569-3

Ask a doctor before use if

  • you have liver disease

Section 50570-1

Do not use

  • if you are allergic to acetaminophen
  • 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 carnauba wax, colloidal silicon dioxide, D&C red #27 aluminum lake, FD&C blue #2 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, microcrystalline cellulose, polyethylene glycol (PEG) 400, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, talc, titanium dioxide

Section 51945-4

Section 53413-1

Questions or comments? Call 1-877-290-4008

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1

Purposes

Pain reliever

Pain reliever aid

Section 55106-9

Active ingredients (in each caplet)

Acetaminophen 500 mg

Caffeine 65 mg


Structured Label Content

Indications and Usage (34067-9)

Uses

Temporarily relieves minor aches and pains due to:

  • headache
  • muscular aches
Dosage and Administration (34068-7)

Directions

  • do not use more than directed
  • adults and children 12 years and over: take 2 caplets every 6 hours; not more than 6 caplets in 24 hours
  • children under 12 years: ask a doctor
Warnings and Precautions (34071-1)

Warnings

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stop use and seek medical help right away.

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 6 caplets 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

Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. 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.

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.

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • any new symptoms occur
  • painful area is red or swollen
  • pain gets worse or lasts for more than 10 days
  • fever gets worse or lasts for more than 3 days

These could be signs of a serious condition.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin
Section 50569-3 (50569-3)

Ask a doctor before use if

  • you have liver disease

Section 50570-1 (50570-1)

Do not use

  • if you are allergic to acetaminophen
  • 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 carnauba wax, colloidal silicon dioxide, D&C red #27 aluminum lake, FD&C blue #2 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, microcrystalline cellulose, polyethylene glycol (PEG) 400, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, talc, titanium dioxide

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments? Call 1-877-290-4008

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)

Purposes

Pain reliever

Pain reliever aid

Section 55106-9 (55106-9)

Active ingredients (in each caplet)

Acetaminophen 500 mg

Caffeine 65 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)