Maximum Strength Mucus Relief Plus Pain And Headache Capsule, Liquid Filled
FDA Label NDC 83059-0052

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Shield Pharmaceuticals Corp for the product Maximum Strength Mucus Relief Plus Pain And Headache (NDC 83059-0052). 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, active ingredient (in each softgel), purpose, uses, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Other

Drug Facts

Distributed by:
Shield Pharmaceuticals Corp.
Ronkonkoma, NY 11779

Active Ingredient (In Each Softgel)

Acetaminophen 325 mg
Guaifenesin 200 mg

Purpose

Pain reliever/fever reducer
Expectorant

Uses

  • temporarily relieves these common cold and flu symptoms:
  • minor aches and pains
  • headache
  • sore throat
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid
  • the bronchial passageways of bothersome mucus and make coughs more productive
  • temporarily reduces fever

Warnings

Liver warning:This product contains acetaminophen. 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
    • blisters
    • rash
    • If a skin reaction occurs, stop use and seek medical help right away.

      Sore throat warning:If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Otc - 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.

Otc - Ask Doctor

Ask a doctor before use if you have

  • liver disease
  • 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

Otc - Stop Use

Stop use and ask a doctor if

  • pain 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

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Overdosage

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. 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 softgels in any 24-hour period
  • adults and children 12 years of age and over: take 2 softgels every 4 hours
  • children under 12 years of age: do not use

Other Information

  • store at 20-25°C (68-77°F)
  • avoid excessive heat

Questions Or Comments?

1-800-373-6981 (toll-free)

Inactive Ingredients

FD&C blue no. 1, gelatin, glycerin, hypromellose, lecithin, light mineral oil, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide

Principal Display Panel

ValuRx

Maximum Strength 

Mucus Relief +
Pain & Headache

Carton

Carton (Carton)

Carton (Carton)

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