Tension Headache Relief

Tension Headache Relief
SPL v7
SPL
SPL Set ID 54aff6a0-2778-472f-90ba-375d6bce6ee8
Route
ORAL
Published
Effective Date 2020-11-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg) Caffeine (65 mg)
Inactive Ingredients
Silicon Dioxide Croscarmellose Sodium D&c Red No. 27 Fd&c Blue No. 2 Fd&c Yellow No. 6 Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Polyvinyl Alcohol, Unspecified Povidone K30 Starch, Pregelatinized Corn Water Stearic Acid Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: S431 Shape: capsule Color: red Size: 18 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-11-17

Description

Drug Facts


Medication Information

Warnings and Precautions

Warnings

Liver Warning: This product contains acataminophen. Severe liver damage may occure if you take.

  • more than 6 caplets in 24 hours, whihc is the maximum daily amount.
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

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.

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, beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat.

Description

Drug Facts

Uses
  • temporarily relieves minor aches and pains due to:
  • headache
  • muscular aches
Section 42229-5

Drug Facts

Section 50565-1

Keep Out of Reach of Children

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

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 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 53414-9

If pregnant or breast feeding,

ask a health professional before use.

Section 55105-1
Active ingredients (in each caplet) Purposes
 Acetaminophen 500 mg  Pain reliever
 Caffeine 65 mg  Pain reliever aid

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
Other Information
  • store at 20°-25°C (68°-77°F)
  • close cap tightly after use
  • read all product information before using. Keep this box for important information.
Inactive Ingredients

colloidal silicon dioxide, croscarmellose sodium, D&C Red#27, FD&C Blue#2, FD&C Yellow#6, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, purified water, stearic acid, talc, titanium dioxide

Questions Or Comments?

1-888-333-9792

Principal Display Panel

Tension Headache Relief

• Acetaminophen & Caffeine

Pain Reliever/ Pain reliever aid

Actual Size


Structured Label Content

Uses
  • temporarily relieves minor aches and pains due to:
  • headache
  • muscular aches
Warnings and Precautions (34071-1)

Warnings

Liver Warning: This product contains acataminophen. Severe liver damage may occure if you take.

  • more than 6 caplets in 24 hours, whihc is the maximum daily amount.
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

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.

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, beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat.

Section 42229-5 (42229-5)

Drug Facts

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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. 1-800-222-1222

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 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 53414-9 (53414-9)

If pregnant or breast feeding,

ask a health professional before use.

Section 55105-1 (55105-1)
Active ingredients (in each caplet) Purposes
 Acetaminophen 500 mg  Pain reliever
 Caffeine 65 mg  Pain reliever aid

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
Other Information (Other information)
  • store at 20°-25°C (68°-77°F)
  • close cap tightly after use
  • read all product information before using. Keep this box for important information.
Inactive Ingredients (Inactive ingredients)

colloidal silicon dioxide, croscarmellose sodium, D&C Red#27, FD&C Blue#2, FD&C Yellow#6, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, purified water, stearic acid, talc, titanium dioxide

Questions Or Comments? (Questions or comments?)

1-888-333-9792

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Tension Headache Relief

• Acetaminophen & Caffeine

Pain Reliever/ Pain reliever aid

Actual Size


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)