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  5. Label Information: Sohmed Cold Relief

FDA Label for Sohmed Cold Relief

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. OTC - ASK DOCTOR/PHARMACIST
    8. OTC - WHEN USING
    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 TABLET BOTTLE CARTON

Sohmed Cold Relief 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

Sore throat warning : if sore throat is severe, persists, for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting, consult a doctor promptly.

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.

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
Dextromethorphan HBr 10 mgCough suppressant
Guaifenesin 200 mgExpectorant
Phenylephrine HCl 5 mgNasal decongestant

Uses



  • for the temporary relief of the following cold symptoms
  • minor aches and pain
  • headache
  • sore throat
  • nasal congestion
  • cough
  • sinus congestion and pressure
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.

Liver Warning



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

  • more than 12 caplets in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

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, psychiatric 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
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
  • cough that occurs with too much phlegm (mucus)

Otc - Ask Doctor/Pharmacist



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


Otc - When Using



When using this product do not exceed recommended dosage


Stop Use And Ask A Doctor If



  • nervousness, dizziness, or sleeplessness occur
  • pain, nasal congestion or cough 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
  • cough comes back or occurs with rash or headache that lasts
  • 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 overdose, 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 with water every 6-8 hours as needed
    • do not take more than 8 caplets in 24 hours
    • children under 12 years
      • consult a doctor

Other Information



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

Inactive Ingredients



colloidal silicon dioxide, sodium lauryl sulphate, edetate disodium, dioctyl sodium sulphosuccinate, polyvinyl pyrollidone, gelatin, corn starch, magnesium stearate, microcrystalline cellulose, polyethylene glycol 6000, sodium benzoate, sodium starch glycolate, stearic acid, purified talc, D&C yellow# 10 aluminium lake, titanium dioxide.

DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN


Question Or Comments?



1(856) 2863646


Principal Display Panel - 24 Tablet Bottle Carton



NDC XXXXXXXXXX

SohMed™
*Compare to the active ingredients in Tylenol® Cold Head Congestion Severe

Cold Relief

Acetaminophen 325mg, Dextromethorphan HBr 10mg,
Guaifenesin 200mg, Phenylephrine HCl 5mg

24 Caplets

Pain Reliever, Fever Reducer,
Nasal Decongestant,
Cough Suppressant, expectorant

Principal Display Panel - 24 Tablet Bottle Carton - sohmed 01

Principal Display Panel - 24 Tablet Bottle Carton - sohmed 01


* Please review the disclaimer below.