Mucus Relief Sinus Severe Congestion And Pain Tablet, Coated
FDA Label NDC 46122-712

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Amerisource Bergen for the product Mucus Relief Sinus Severe Congestion And Pain (NDC 46122-712). 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, allergy alert, do not use, ask a doctor before use if you have, otc - ask doctor/pharmacist, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Other

Drug Facts

Otc - Purpose

Active ingredients (in each caplet)Purpose
Acetaminophen 325 mgPain reliever
Guaifenesin 200 mgExpectorant
Phenylephrine HCl 5 mgNasal decongestant

Uses

  • temporarily relieves:
    • nasal congestion
    • headache
    • minor aches and pains
    • sinus congestion and pressure
    • promotes nasal and/or sinus drainage
    • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and 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 daily while using this product

Allergy Alert

Acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • 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.

Ask A Doctor Before Use If You Have

  • liver disease
  • heart disease
  • diabetes
  • high blood pressure
  • thyroid disease
  • 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 use more than directed

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 persistent headache
  • 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 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

  • do not take more than directed (see Overdose warning)
  • do not take more than 12 caplets in any 24-hour period
  • adults and children 12 years and older:  take 2 caplets every 4 hours
  • children under 12 years of age:  do not use

Other Information

  • store between 20-25°C (68-77°F) in a dry place
  • retain outer package for complete product information

Inactive Ingredients

colloidal silicon dioxide, corn starch, croscarmellose sodium, crospovidone, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, stearic acid, talc, titanium dioxide

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GOOD NEIGHBOR PHARMACY®

Compare to Mucinex® Sinus-Max® Severe Congestion & Pain active ingredients†

NDC 46122-712-60

Maximum Strength

For Ages 12+

Mucus Relief Sinus Severe Congestion & Pain

Acetaminophen, guaifenesin, phenylephrine hcl

pain reliever, experctorant, nasal decongestant

• Clears Sinus Congestion   • Relieves Headache

• Thins & Loosens Mucus

20 CAPLETS

actual size

Image Description (F116702gnp R0)

Image Description (F116702gnp R0)

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