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  5. Label Information: Sohmed Extra Strength

FDA Label for Sohmed Extra Strength

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENTS (IN EACH CAPLET)
    3. PURPOSE
    4. USE
    5. LIVER WARNING
    6. DO NOT USE
    7. OTC - ASK DOCTOR
    8. OTC - ASK DOCTOR/PHARMACIST
    9. STOP USE AND ASK A DOCTOR IF
    10. OTC - PREGNANCY OR BREAST FEEDING
    11. OTC - KEEP OUT OF REACH OF CHILDREN
    12. OVERDOSE WARNING
    13. DIRECTIONS
    14. OTHER INFORMATION
    15. INACTIVE INGREDIENTS
    16. QUESTIONS OR COMMENTS?
    17. PRINCIPAL DISPLAY PANEL - 24 TABLET BOTTLE CARTON

Sohmed Extra Strength Product Label

The following document was submitted to the FDA by the labeler of this product Sohm Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



Drug Facts

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


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

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.

Otc - Ask Doctor



Ask a doctor before use if you have liver disease


Otc - Ask Doctor/Pharmacist



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.

Otc - Pregnancy Or Breast Feeding



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


Otc - Keep Out Of Reach Of Children



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)

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 yearsask a doctor

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


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

Principal Display Panel - 24 Tablet Bottle Carton - acetaminophen 01

Principal Display Panel - 24 Tablet Bottle Carton - acetaminophen 01


* Please review the disclaimer below.