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Acetaminophen, Neomycin Sulfate, Polymyxin B Sulfate, Pramoxine Hydrochloride

OTC RxCUI 198440
Contents

Overview

Label date
2025-11-06

Indications and usage

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

Uses first aid to help prevent infection and for the temporary relief of pain in minor: cuts scrapes burns

Purpose

Pain reliever/fever reducer

Active ingredients (in each gram) Purpose Neomycin Sulfate (3.5 mg) First aid antibiotic Polymyxin B Sulfate (10,000 units) First aid antibiotic Pramoxine HCl (10 mg) External analgesic

Dosage and administration

Directions do not take more than directed (see overdose warning) adults and children 12 years and over take 2 caplets every 6 hours while symptoms last do not take more than 6 caplets 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 adults and children 2 years of age and older: clean the affected area apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily may be covered with a sterile bandage children under 2 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 if you are allergic to any of the ingredients in the eyes over large areas of the body Ask a doctor before use if you have deep or puncture wounds animal bites serious burns Stop use and ask a doctor if you need to use longer than 1 week condition persists or gets worse symptoms persist for more than 1 week, or clear up and occur again within a few days rash or other allergic reaction develops Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Centre 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

if you are allergic to any of the ingredients in the eyes over large areas of the body

Ask a doctor before use if

Ask a doctor before use if you have liver disease

Ask a doctor before use if you have deep or puncture wounds animal bites serious burns

Ask a doctor or pharmacist before use if

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

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 you need to use longer than 1 week condition persists or gets worse symptoms persist for more than 1 week, or clear up and occur again within a few days rash or other allergic reaction develops

Pregnancy or breast-feeding

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

Active ingredient (label)

(in each caplet) Acetaminophen 500 mg

s (in each gram) Purpose Neomycin Sulfate (3.5 mg) First aid antibiotic Polymyxin B Sulfate (10,000 units) First aid antibiotic Pramoxine HCl (10 mg) External analgesic

Inactive ingredients

s carnauba wax*, corn starch*, FD&C red no. 40 aluminum lake, hypromellose, magnesium stearate, modified starch*, polyethylene glycol*, powdered cellulose, pregelatinized starch, propylene glycol, shellac, sodium starch glycolate, titanium dioxide *contains one or more of these ingredients

s Water, Emulsifying Wax, Mineral Oil, Petrolatum, Propylene Glycol, Methylparaben, Sulfuric acid, Sodium Hydroxide

Storage and handling

Other information store between 20-25°C (68-77°F) do not use if pouch is torn or damaged

Other information store at 20° to 25°C (68° to 77°F) Product may settle

Keep out of reach of children

of children.

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