Headache - Dolor De Cabeza (acetaminophen 500mg; Caffeine 65mg)

Headache - Dolor De Cabeza (acetaminophen 500mg; Caffeine 65mg)
SPL v2
SPL
SPL Set ID 92355f58-ebb6-b78f-e053-2995a90a4aef
Route
ORAL
Published
Effective Date 2018-12-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg) Caffeine (65 mg)
Inactive Ingredients
Silicon Dioxide Fd&c Blue No. 2 Croscarmellose Magnesium Stearate Starch, Corn Talc Sodium Starch Glycolate Type A Corn Titanium Dioxide Polyvinyl Alcohol, Unspecified Food Yellow 3 Free Acid Cellulose, Microcrystalline Polyethylene Glycol 400 D&c Red No. 27

Identifiers & Packaging

Pill Appearance
Imprint: S777 Shape: capsule Color: red Size: 18 mm Score: 1
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2018-12-20

Description

Acetaminophen 500mg; Caffeine 65mg


Medication Information

Warnings and Precautions

Liver warning:

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

  • more than 6 caplets in 24 hours, which is the maimum 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 or beverages while takingthis product because too much caffeine may cause nervousness, irritability, sleeplessness, and occassionally rapis heart beat.

Do not use

  • if you are allergic to acetaminophen
  • with any other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist

Ask a doctor before use if you have

  • liver disease

Ask a doctor or a pharmacist before use if

you are taking the blood thinning drug warfarin

Stop use and ask a doctor if

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

These could be signs of a serious comdition

If pregnant or breast-feeding,

ask a health professional before use

Keep out of reach of children

Overdose warning: In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Indications and Usage

*temporarily relieves minor aches and pains due to:

  • headache
  • muscular aches
Dosage and Administration
  • take with a full glass of water
  • do not take more than directed
  • do not take more than 6 caplets in 24 hours
adults and children 12 years of age and over take 2 caplets every 6 hours, not more than 6 caplets in 24 hours
children under 12 years of age ask a doctor

Description

Acetaminophen 500mg; Caffeine 65mg

Section 50565-1

Keep out of reach of children

Overdose Warning: In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 51727-6

colloidal silicon dioxide, croscarmellose sodium, D&C red #27, FD&C blue #2, FD&C yellow #6, magnesium stearate, maize starch, microcrystalline cellulose, polyethylene glycol, pregalatinized starch, polyvinyl alcohol, sodium starch glycolate, talc, titanium dioxide

Section 51945-4

Section 55105-1

Pain reliever ; Pain reliever aid

Section 55106-9

Acetaminophen 500mg; Caffeine 65mg

Section 60561-8
  • store at room temperature between 20 ºC - 25 ºC (68 ºF - 77 ºF)

Structured Label Content

Indications and Usage (34067-9)

*temporarily relieves minor aches and pains due to:

  • headache
  • muscular aches
Dosage and Administration (34068-7)
  • take with a full glass of water
  • do not take more than directed
  • do not take more than 6 caplets in 24 hours
adults and children 12 years of age and over take 2 caplets every 6 hours, not more than 6 caplets in 24 hours
children under 12 years of age ask a doctor

Warnings and Precautions (34071-1)

Liver warning:

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

  • more than 6 caplets in 24 hours, which is the maimum 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 or beverages while takingthis product because too much caffeine may cause nervousness, irritability, sleeplessness, and occassionally rapis heart beat.

Do not use

  • if you are allergic to acetaminophen
  • with any other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist

Ask a doctor before use if you have

  • liver disease

Ask a doctor or a pharmacist before use if

you are taking the blood thinning drug warfarin

Stop use and ask a doctor if

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

These could be signs of a serious comdition

If pregnant or breast-feeding,

ask a health professional before use

Keep out of reach of children

Overdose warning: In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 50565-1 (50565-1)

Keep out of reach of children

Overdose Warning: In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 51727-6 (51727-6)

colloidal silicon dioxide, croscarmellose sodium, D&C red #27, FD&C blue #2, FD&C yellow #6, magnesium stearate, maize starch, microcrystalline cellulose, polyethylene glycol, pregalatinized starch, polyvinyl alcohol, sodium starch glycolate, talc, titanium dioxide

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Pain reliever ; Pain reliever aid

Section 55106-9 (55106-9)

Acetaminophen 500mg; Caffeine 65mg

Section 60561-8 (60561-8)
  • store at room temperature between 20 ºC - 25 ºC (68 ºF - 77 ºF)

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)