SohMed Extra Strength

SOHM Inc.

SohMed™ Extra Strength

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredients (in each caplet)
• Purpose
• Use
• Warnings
  • Liver warning
  • Do not use
  • Stop use and ask a doctor if
  • Overdose warning
• Directions
• SohMed Extra Strength Other information
• Inactive ingredients
• Questions or comments?
• PRINCIPAL DISPLAY PANEL - 24 Tablet Bottle Carton

FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredients (in each caplet)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Use

• 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

Warnings

Liver warning

This product contains acetaminophen. The maximum daily dose of this product is 6 caplets (3,000 mg) in 24 hours. 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

Although rare, possible reactions to consumption of acetaminophen include three serious skin diseases whose symptoms can include rash, blisters and, in the worst case, widespread damage to the surface of the skin. If you are taking this product and develop a rash or other skin reaction, stop taking this product immediately and seek medical attention.

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

Taking more than the recommended dose (overdose) may cause liver damage. 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.

Directions

do not take more than directed (see overdose warning)

SohMed Extra Strength Other information

• store between 20°-25°C (68°-77°F)
• See end flap for expiration date and lot number

Inactive ingredients

carnauba wax*contains one or more of these ingredients, castor oil*contains one or more of these ingredients, corn starch, FD&C red #40 aluminum lake, hypromellose, magnesium stearate, polyethylene glycol*contains one or more of these ingredients, powdered cellulose, pregelatinized starch, propylene glycol, shellac, sodium starch glycolate, titanium dioxide.

Contains No Aspirin

Questions or comments?

1(856) 2863646

Distributed by : Sohm, Inc.
6920 Knott Ave., Suit A-C,
Buena Park, CA 90621

PRINCIPAL DISPLAY PANEL - 24 Tablet Bottle Carton

NDC XXXXXXXXXX

SohMed™

*Compare to the active ingredient of Extra Strength Tylenol^® Caplets

Extra Strength

Pain Relief

Acetaminophen

Acetaminophen 500 mg

Pain reliever • Fever reducer

contains no aspirin

24 Caplets