Daytime Cold And Flu Maximum Strength Capsule, Liquid Filled
FDA Label NDC 83059-0178

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 Daytime Cold And Flu Maximum Strength (NDC 83059-0178). 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
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer
Cough suppressant
Nasal decongestant

Uses

  • temporarily relieves these symptoms due to a cold or flu:
  • minor aches and pains
  • headache
  • cough
  • nasal congestion
  • sore throat
  • sinus congestion and pressure
  • temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 4000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks daily while using this product
  • Allergy alert: Acetaminophen may cause severe skin or severe allergic reactions. Symptoms may include:

    • skin reddening
    • blisters
    • rash
    • hives
    • facial swelling
    • asthma (wheezing)
    • shock.
      If a skin or general allergic 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 is 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.
  • 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
  • in children under 12 years of age

Otc - Ask Doctor

Ask a doctor before use if you have

  • liver diseaseheart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • cough with excessive phlegm (mucus)
  • difficulty in urination due to enlargement of the prostat gland
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema

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, cough, or nasal congestion 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
  • nervousness, dizziness, or sleeplessness occurs

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. 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 & for children even if you do not notice any signs or symptoms.

Directions

  • take only as directed
  • do not exceed 8 softgels per 24 hrs
  • adults & children 12 yrs & over2 Softgels with water every 4 hrs. Do not exceed6 softgels in 12 hours or as directed by a doctor
    children under 12 yrsdo not use

Other Information

• store between 20-25°C (68-77°F).
Avoid high humidity and excessive heat.
Protect from light.

Inactive Ingredients

anhydrous citric acid, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, glycerin, isopropyl alcohol, N-butyl alcohol, polyethylene glycol-400, povidone (PVP K30), propylene glycol, purified water, shellac, Sorbitol Solution, titanium dioxide

Questions Or Comments?

1-800-373-6981

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Daytime Cold & Flu
Maximum Strength

Acetaminophen
Dextromethorphan HBr
Phenylephrine HCl

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