Sinus Plus Headache Tablet, Coated
FDA Label NDC 36800-322

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Topcare for the product Sinus Plus Headache (NDC 36800-322). 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, 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

Otc - Purpose

Active ingredients (in each caplet)Purpose
Acetaminophen 325 mgPain reliever/fever reducer
Phenylephrine HCl 5 mgNasal decongestant

Uses

  • temporarily relieves these symptoms associated with hay fever or other upper respiratory allergies, and the common cold:
    • headache
    • sinus congestion and pressure
    • nasal congestion
    • minor aches and pains
    • helps decongest sinus openings and passages
    • promotes sinus drainage
    • helps clear nasal passages
    • temporarily reduces fever

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

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

Otc - Ask Doctor

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

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 exceed recommended dosage

Otc - Stop Use

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur
  • pain 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
  • 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

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)
  • 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 20-25°C (68-77°F) in a dry place
  • retain carton for complete product information and warnings

Inactive Ingredients

acesulfame potassium, colloidal silicon dioxide, croscarmellose sodium, crospovidone, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, propylene glycol, stearic acid, talc, titanium dioxide

Principal Display Panel

TopCare health®

COMPARE TO TYLENOL® SINUS+ HEADACHE ACTIVE INGREDIENTS*

NDC 36800-322-05

NON-DROWSY

DAYTIME

Sinus + Headache

PAIN RELIEVER/FEVER REDUCER • ACETAMINOPHEN

NASAL DECONGESTANT • PHENYLEPHRINE HCl

RELIEF OF:

• Sinus Headache • Sinus Pressure

• Nasal Congestion

24 COOL TASTE CAPLETS

For Adults

actual size

* Please review the disclaimer below.