Sohmed™ Cold Relief

Sohmed™ Cold Relief
SPL v1
SPL
SPL Set ID 35ca55b2-edcc-4108-945e-2e368b60cbc8
Route
ORAL
Published
Effective Date 2013-08-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Dextromethorphan (10 mg) Guaifenesin (200 mg) Phenylephrine (5 mg)
Inactive Ingredients
Silicon Dioxide Sodium Lauryl Sulfate Edetate Disodium Docusate Sodium Starch, Corn Povidone K90 Gelatin Magnesium Stearate Cellulose, Microcrystalline Polyethylene Glycol 6000 Sodium Benzoate Sodium Starch Glycolate Type A Corn Stearic Acid Talc D&c Yellow No. 10 Aluminum Oxide Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: CRX Shape: oval Color: yellow 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 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.
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
Dextromethorphan HBr 10 mg Cough suppressant
Guaifenesin 200 mg Expectorant
Phenylephrine HCl 5 mg Nasal decongestant
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
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 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
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.

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

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.
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 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


Structured Label Content

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.
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
Dextromethorphan HBr 10 mg Cough suppressant
Guaifenesin 200 mg Expectorant
Phenylephrine HCl 5 mg Nasal decongestant
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
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 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
Overdose Warning (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.

Other Information (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 (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? (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 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.
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 Tablet Bottle Carton (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


Advanced Ingredient Data


Raw Label Data

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