Sohmed™ Extra Strength

Sohmed™ Extra Strength
SPL v1
SPL
SPL Set ID 5c05b1c5-1bd5-4c58-ad83-f5b14c436a40
Route
ORAL
Published
Effective Date 2013-08-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg)
Inactive Ingredients
Carnauba Wax Castor Oil Starch, Corn Fd&c Red No. 40 Aluminum Oxide Hypromelloses Magnesium Stearate Polyethylene Glycol 6000 Powdered Cellulose Propylene Glycol Shellac Sodium Starch Glycolate Type A Corn Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: CRX Shape: oval Color: red Size: 18 mm Score: 2
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2013-08-25
Description

Drug Facts

Purpose

Pain reliever/fever reducer

Medication Information

Purpose

Pain reliever/fever reducer

Description

Drug Facts

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
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Section 50568-5

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

Section 50569-3

Ask a doctor before use if you have liver disease

Section 53414-9

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

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
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.
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.

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.

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
, corn starch, FD&C red #40 aluminum lake, hypromellose, magnesium stearate, polyethylene glycol
, powdered cellulose, pregelatinized starch, propylene glycol, shellac, sodium starch glycolate, titanium dioxide.

Contains No Aspirin

Questions Or Comments?

1(856) 2863646

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.
Active Ingredients (in Each Caplet)

Acetaminophen 500 mg

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

Structured Label Content

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
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50568-5 (50568-5)

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

Section 50569-3 (50569-3)

Ask a doctor before use if you have liver disease

Section 53414-9 (53414-9)

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

Purpose

Pain reliever/fever reducer

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
Do Not Use (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.
Liver Warning (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.

Overdose Warning (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.

Other Information (Other information)
  • store between 20°-25°C (68°-77°F)
  • See end flap for expiration date and lot number
Inactive Ingredients (Inactive ingredients)

carnauba wax

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

Contains No Aspirin

Questions Or Comments? (Questions or comments?)

1(856) 2863646

Stop Use and Ask A Doctor If (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.
Active Ingredients (in Each Caplet) (Active ingredients (in each caplet))

Acetaminophen 500 mg

Principal Display Panel 24 Tablet Bottle Carton (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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:55:41.575533 · Updated: 2026-03-14T22:53:35.209708