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  5. Label Information: Sohmed Allergy Sinus

FDA Label for Sohmed Allergy Sinus

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. OTC - PURPOSE
    3. USES
    4. LIVER WARNING
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE
    7. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    8. WHEN USING THIS PRODUCT
    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. QUESTION OR COMMENTS?
    17. PRINCIPAL DISPLAY PANEL - 24 CAPLET BOTTLE CARTON

Sohmed Allergy Sinus 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


Otc - Purpose



Active ingredients (in each caplet)Purpose
Acetaminophen 325 mgPain reliever
Chlorpheniramine maleate 2 mgAntihistamine
Phenylephrine HCl 5 mgNasal decongestant

Uses



  • temporarily relieves these symptoms of hay fever or other upper respiratory allergies :
    • headache
    • sinus congestion and pressure
    • nasal congestion
    • itchy, watery eyes
    • runny nose and sneezing
    • minor aches and pains
    • itching of the nose or throat
    • helps decongest sinus openings and passages

Liver Warning



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

  • more than 8 caplets in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks everyday 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 now taking a prescription monoamine oxidase inhibitor (MAOI) (Certain drugs for depression, pscychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. if you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
  • if you have ever had an allergic reaction to this product or any of its ingredients

Ask A Doctor Before Use If You Have



  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma

Ask A Doctor Or Pharmacist Before Use If You Are



  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

When Using This Product



  • do not exceed recommended dosage
  • excitability may occur, especially in children
  • drowsiness may occur
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery

Stop Use And Ask A Doctor If



  • nervousness, dizziness, or sleeplessness occur
  • pain or nasal congestion gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur

    • 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



In case of over-dose, get medical help or contact a Poison Control Center right away. Prompt 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 4 hours
    • do not take more than 8 caplets in 24 hours.
    • children under 12 years
      • consult a doctor

Other Information



  • avoid excessive heat and humidity
  • store between 15°-30°C (59°-86°F)
  • See end flap for expiration date and lot number

Inactive Ingredients



colloidal silicon dioxide, sodium lauryl sulphate, edetate disodium, dioctyl sodium sulphosuccinate, polyvinylpyrollidone, gelatin, corn starch, magnesium stearate, microcrystalline cellulose, polyethylene glycol 6000, sodium benzoate, sodium starch glycolate, stearic acid, purified talc, titanium dioxide, yellow iron oxide.


Question Or Comments?



1(856) 2863646


Principal Display Panel - 24 Caplet Bottle Carton



NDC XXXXXXXXXXX

SohMed™
*Compare to the active ingredients in Tylenol:: Allergy Multi-symptom

Multi-Symptom

Allergy Sinus

Acetaminophen 325 mg
Chlorpheniramine maleate 2 mg
Phenylephrine HCl 5 mg

• Sneezing • Runny Nose • Congestion

24 Caplets

Principal Display Panel - 24 Caplet Bottle Carton - allergy sinus 01

Principal Display Panel - 24 Caplet Bottle Carton - allergy sinus 01


* Please review the disclaimer below.