Sohmed™ Sinus

Sohmed™ Sinus
SPL v1
SPL
SPL Set ID c0b0e4f1-bceb-4662-928b-c24730be0ba4
Route
ORAL
Published
Effective Date 2013-08-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Guaifenesin (200 mg) Phenylephrine (5 mg)
Inactive Ingredients
Silicon Dioxide Sodium Lauryl Sulfate Edetate Disodium Di-2-hexyl Sodium Sulfosuccinate Starch, Corn Povidone K90 Gelatin Magnesium Stearate Cellulose, Microcrystalline Polyethylene Glycol 6000 Sodium Benzoate Sodium Starch Glycolate Type A Corn Stearic Acid Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: CRX Shape: oval Color: white Size: 18 mm Score: 2
Marketing Status
OTC MONOGRAPH FINAL Active Since 2013-08-25

Description

Drug Facts


Medication Information

Description

Drug Facts

Uses
  • for the temporary relief of :
    • sinus congestion and pressure
    • headache
    • nasal congestion
    • minor aches and pains
    • helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive
  • temporarily relieves nasal congestion due to the common cold, and hay fever and other upper respiratory allergies
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Section 50567-7

When using this product do not exceed recommended dosage

Section 50568-5

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

Section 53414-9

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

Section 55105-1
Active ingredients (in each caplet) purpose
Acetaminophen 325 mg Pain reliever
Guaifenesin 200mg Expectorant
Phenylephrine HCL 5mg Nasal decongestant
Directions
  • adults and children 12 years and over
    • take 1-2 caplets every 4 hours as needed
    • do not take more than 8 caplets in 24 hours
  • children under 12 years
    • consult 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 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
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 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

In case of overdose, get medical help or contact a PoisonControl 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.

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, polyvinyl pyrollidone, gelatin, corn starch, magnesium stearate, microcrystalline cellulose, polyethylene glycol 6000, sodium benzoate, sodium starch glycolate, stearic acid, purified talc, titanium dioxide

Question Or Comments?

1(856) 2863646

Stop Use and Ask A Doctor If
  • nervousness, dizziness, or sleeplessness occur
  • pain nasal congestion or cough gets worse or lasts for more than 7 days
  • fever gets worse or lasts for 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.

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)
Principal Display Panel 24 Caplet Bottle Carton

SohMed

NDC XXXXXXXXXX

*Compare to the active ingredients in Tylenol ® Sinus Congestion

& Pain Severe Day Time

SEVERE

Sinus Congestion & Pain Relief

Acetaminophen 325 mg, Guaifenesin 200 mg,

Phenylephrine HCl 5 mg

Relieves Sinus Pressure, Nasal Congestion and Fever

24 Caplets

Daytime

Non-Drowsy


Structured Label Content

Uses
  • for the temporary relief of :
    • sinus congestion and pressure
    • headache
    • nasal congestion
    • minor aches and pains
    • helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive
  • temporarily relieves nasal congestion due to the common cold, and hay fever and other upper respiratory allergies
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50567-7 (50567-7)

When using this product do not exceed recommended dosage

Section 50568-5 (50568-5)

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

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)
Active ingredients (in each caplet) purpose
Acetaminophen 325 mg Pain reliever
Guaifenesin 200mg Expectorant
Phenylephrine HCL 5mg Nasal decongestant
Directions
  • adults and children 12 years and over
    • take 1-2 caplets every 4 hours as needed
    • do not take more than 8 caplets in 24 hours
  • children under 12 years
    • consult 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 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
Liver Warning (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 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)

In case of overdose, get medical help or contact a PoisonControl 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.

Other Information (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 (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, titanium dioxide

Question Or Comments? (Question or comments?)

1(856) 2863646

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • nervousness, dizziness, or sleeplessness occur
  • pain nasal congestion or cough gets worse or lasts for more than 7 days
  • fever gets worse or lasts for 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.

Ask A Doctor Before Use If You Have (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)
Principal Display Panel 24 Caplet Bottle Carton (PRINCIPAL DISPLAY PANEL - 24 Caplet Bottle Carton)

SohMed

NDC XXXXXXXXXX

*Compare to the active ingredients in Tylenol ® Sinus Congestion

& Pain Severe Day Time

SEVERE

Sinus Congestion & Pain Relief

Acetaminophen 325 mg, Guaifenesin 200 mg,

Phenylephrine HCl 5 mg

Relieves Sinus Pressure, Nasal Congestion and Fever

24 Caplets

Daytime

Non-Drowsy


Advanced Ingredient Data


Raw Label Data

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