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.

Active Ingredient

Acetaminophen 500mg; Caffeine 65mg

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

Structured Label Content

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.

Active Ingredient (55106-9)

Acetaminophen 500mg; Caffeine 65mg

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

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

Advanced Ingredient Data


Raw Label Data

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