Sinus Congestion And Pain Relief
FDA Label NDC 70005-012

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by We Care Distributor Inc. for the product Sinus Congestion And Pain Relief (NDC 70005-012). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, otc - purpose, uses, liver warning:, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Otc - Purpose

 
 Active Ingredient (in each tablet) Purpose
 Acetaminophen 325 mg Pain reliever/fever reducer
 Guaifenesin 200 mg

Expectorant

Phenylephrine HCl 5 mg

Nasal decongestant

 

Uses

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

Liver Warning:

This product contains acetaminophen. The maximum daily dose of this product is 10 tablets (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

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 monomine 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
  • thyroid disease
  • diabetes
  • high blood pressure
  • persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis,or emphysema
  • trouble urinating due to an enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)

Ask A Doctor Or Pharmacist Before Use If You Are

  • taking the blood thinning drug warfarin

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
  • new symptoms occur
  • redness or swelling is present
  • 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: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick 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 tablets every 4 hours

  • swallow whole - do not crush, chew or dissolve

  • do not take more than 10 tablets in 24 hours

  • children under 12 years: ask a doctor

Other Information

  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

  • read all product information before using. Keep this box for important information

Inactive Ingredients

FD&C red #40, maltodextrin, microcrystalline cellulose, povidone, sodium starch glycolate, starch, stearic acid

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Compare to the Active Ingredients in

Tylenol® Sinus Congestion & Pain Severe

Acetaminophen, Guaifenesin and Phenylephrine HCl 325 mg, 200 mg and 5 mg

TO OPEN
PUSH IN TAB AND PULL OUT

25 Pouches of 2 Tablets Each

Principal Display Panel (50 Pouch Box)

Principal Display Panel (50 Pouch Box)

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