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Acetaminophen, Lidocaine, Menthol

OTC RxCUI 198440
Contents

Overview

Label date
2024-11-26

Indications and usage

Uses

  • temporarily relieves minor aches and pains due to: headache muscular aches backache minor pain of arthritis the common cold toothache premenstrual and menstrual cramps
  • temporarily reduces fever

Uses For the temporary relief of pain

Purpose

Pain reliever/fever reducer

Topical analgesic Topical analgesic

Dosage and administration

Directions do not take more than directed (see overdose warning ) adults and children 12 years and over

  • take 2 gelcaps every 6 hours while symptoms last
  • do not take more than 6 gelcaps in 24 hours, unless directed by a doctor
  • do not use for more than 10 days unless directed by a doctor children under 12 years ask a doctor

Directions

  • use only as directed
  • adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 12 years of age: ask a doctor

Warnings

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

  • more than 4,000 mg of acetaminophen in 24 hours
  • 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. 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.
  • if you are allergic to acetaminophen or any of the inactive ingredients in this product Ask a doctor before use if you have liver disease Ask a doctor or 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
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • redness or swelling is present These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Overdose warning 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.

For external use only. Do not use

  • in large quantities, particularly over raw surfaces or blistered areas When using this product
  • avoid contact with eyes Stop use and ask a doctor if
  • condition worsens or symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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.
  • if you are allergic to acetaminophen or any of the inactive ingredients in this product

Ask a doctor before use if

Ask a doctor before use if you have liver disease

Ask a doctor or pharmacist before use if

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

When using this product

Do not use

  • in large quantities, particularly over raw surfaces or blistered areas

this product

  • avoid contact with eyes

Stop use and ask a doctor if

and ask a doctor if

  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • redness or swelling is present These could be signs of a serious condition.

and ask a doctor if

  • condition worsens or symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days

Pregnancy or breast-feeding

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

Active ingredient (label)

(in each gelcap) Acetaminophen 500 mg

Lidocaine 4% Menthol 1%

Inactive ingredients

s benzyl alcohol, butylparaben, carboxymethylcellulose sodium, D&C yellow no. 10, edetate calcium disodium, FD&C blue no. 1, FD&C red no. 40, gelatin, hypromellose, iron oxide, magnesium stearate, methylparaben, modified starch, polyethylene glycol, polysorbate 80, powdered cellulose, pregelatinized starch, propylene glycol, propylparaben, red iron oxide, sodium lauryl sulfate, sodium propionate, sodium starch glycolate, titanium dioxide, yellow iron oxide

s carbomer copolymer, cetearyl olivate, cetyl alcohol, fragrance, glycerin, isopropyl palmitate, phenoxyethanol, sodium polyacrylate, sorbitan olivate, water

Storage and handling

Other information

  • store between 20-25°C (68-77°F). Avoid high humidity.
  • do not use if carton is opened. Do not use if foil inner seal imprinted with “TYLENOL” is broken or missing.

Other Information store at 15

  • to 30
  • C (59
  • to 86
  • F)

Keep out of reach of children

of children.

of children. If swallowed, get medical help or contact a Poison Control Center right away.