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Sinus Congestion and Pain Severe (acetaminophen 325 mg guaifenesin 200 mg phenylephrine hydrochloride 5 mg) Dailymed

  1. Human OTC
  2. Expectorant
  3. Strategic Sourcing Services LLC

Generic: acetaminophen, guaifenesin, and phenylephrine hydrochloride is used for the treatment of Fever Glucosephosphate Dehydrogenase Deficiency Liver Diseases Pain Bronchitis Common Cold Cough Laryngitis Pharyngitis Rhinitis, Allergic, Perennial Sinusitis Whooping Cough Fissure in Ano Glaucoma, Open-Angle Hemorrhoids Hypertension Hypotension Pruritus Ani Rhinitis, Vasomotor Shock, Septic Tachycardia, Supraventricular Mydriasis Tachycardia, Ventricular

Sinus Congestion and Pain Severe tablet, coated - (acetaminophen 325 mg guaifenesin 200 mg phenylephrine hydrochloride 5 mg) image

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  1. FDA Adverse Reactions

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Drug Facts

Otc - Active Ingredient Section


OTC - PURPOSE SECTION

Active ingredients (in each caplet) Purpose
Acetaminophen 325 mg Pain reliever/fever reducer
Guaifenesin 200 mg Expectorant
Phenylephrine HCl 5 mg Nasal decongestant

Uses

  • temporarily relieves these symptoms associated with hay fever or other upper respiratory allergies, and the common cold:
    • sinus congestion and pressure
    • headache
    • nasal congestion
    • minor aches and pains
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
  • temporarily reduces fever

Warnings


Liver warning


This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg acetaminophen) 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

Allergy alert


acetaminophen may cause severe skin reactions. Symptoms may include:
  • skin reddening
  • bulers
  • rash

If a skin reaction occurs, stop use and seek medical help right away.

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 SECTION


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

OTC - WHEN USING SECTION


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 SECTION


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

Keep out of reach of children.


Overdose warning


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

adults and children 12 years and over
  • take 2 caplets every 4 hours
  • swallow whole – do not crush, chew, or dissolve
  • do not take more than 10 caplets in 24 hours
children under 12 years
  • ask a doctor

Other Information

  • store between 20-25ÂşC (68-77ÂşF) in a dry place
  • retain carton for complete product information

Inactive Ingredients


acesulfame potassium, colloidal silicon dioxide, croscarmellose sodium, crospovidone, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, propylene glycol, stearic acid, talc, titanium dioxide

Principal Display Panel


sunmark®

compare to Tylenol® Sinus Severe active ingredients†

NDC 49348-117-04

sinus severe

for adults

Non-Drowsy

Daytime

Sinus headache, sinus pressure, nasal congestion, mucus + chest congestion

Pain Reliever/Fever Reducer  ACETAMINOPHEN

Nasal Decongestant  PHENYLEPHRINE HCL

Expectorant  GUAIFENESIN

COOL TASTE INSTANT COOLING SENSATION

24 CAPLETS



DISCLAIMER:

"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."

"Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service."

"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."

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