SPL v2
SPL
SPL Set ID c66e0b52-5531-4a84-ae90-8a26d27df1ec
Route
ORAL
Published
Effective Date 2026-01-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg) Phenylephrine (5 mg)
Inactive Ingredients
Crospovidone (120 .mu.m) Povidone Cellulose, Microcrystalline Hypromelloses Polyethylene Glycol, Unspecified Starch, Corn Stearic Acid

Identifiers & Packaging

Pill Appearance
Imprint: AZ;261 Shape: round Color: white Size: 12 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-07-01

Description

Active ingredients (in each tablet) Acetaminophen 500mg Phenylephrine HCl 5mg

Purpose

Purpose Pain reliever/fever reducer Nasal decongestant


Medication Information

Purpose

Purpose

Pain reliever/fever reducer

Nasal decongestant

Description

Active ingredients (in each tablet) Acetaminophen 500mg Phenylephrine HCl 5mg

Stop Use

Stop use and ask a doctor if

  • you get nervous, dizzy, or sleepless
  • 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 appear

These could be signs of a serious condition.

Warnings

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.

Questions

Questions or comments? (888) 602-0288

Ask Doctor

Ask a doctor before use if you have

  • liver disease
  • thyroid disease
  • diabetes
  • high blood pressure
  • heart disease
  • trouble urinating due to an enlarged prostate gland
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.
  • for more than 10 days unless directed by a doctor
When Using

When using this product do not exceed recommended dosage.

Active Ingredient

Active ingredients (in each tablet)

Acetaminophen 500mg

Phenylephrine HCl 5mg

Inactive Ingredient

Inactive ingredients

corn starch, crospovidone, hypromelloses, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid.

Indications & Usage

Uses

temporarily relieves these common cold/flu symptoms:

nasal congestion

headache

minor aches and pains

stuffy nose

sinus congestion and pressure

temporarily reduces fever

Ask Doctor/pharmacist

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin
Dosage & Administration

Directions

  • do not use more than directed

Adults and children: (12 years and over) Take 2 tablets every 6 hours. Do not take more than 8 tablets in 24 hours.

Children under 12 years: Ask a doctor

Other Safety Information

Other information

  • store at room temperature 59º-86ºF (15º-30ºC)
  • tamper evident sealed packets
  • do not use any opened or torn packets
  • avoid excessive heat and humidity
Pregnancy Or Breast Feeding

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

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.

Principal Display Panel – 250 Tablet Box Label

ProvisionPlus

Sinu-Phen Plus

Sinus Pain & Pressure Relief

Fast Relief of:

  • Fever
  • Nasal Congestion
  • Body Aches
  • Sinus Pain

250 tablets

2 Per Packet


Structured Label Content

Purpose (PURPOSE)

Purpose

Pain reliever/fever reducer

Nasal decongestant

Stop Use (STOP USE)

Stop use and ask a doctor if

  • you get nervous, dizzy, or sleepless
  • 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 appear

These could be signs of a serious condition.

Warnings (WARNINGS)

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.

Questions (QUESTIONS)

Questions or comments? (888) 602-0288

Ask Doctor (ASK DOCTOR)

Ask a doctor before use if you have

  • liver disease
  • thyroid disease
  • diabetes
  • high blood pressure
  • heart disease
  • trouble urinating due to an enlarged prostate gland
Do Not Use (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.
  • for more than 10 days unless directed by a doctor
When Using (WHEN USING)

When using this product do not exceed recommended dosage.

Active Ingredient (ACTIVE INGREDIENT)

Active ingredients (in each tablet)

Acetaminophen 500mg

Phenylephrine HCl 5mg

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive ingredients

corn starch, crospovidone, hypromelloses, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid.

Indications & Usage (INDICATIONS & USAGE)

Uses

temporarily relieves these common cold/flu symptoms:

nasal congestion

headache

minor aches and pains

stuffy nose

sinus congestion and pressure

temporarily reduces fever

Ask Doctor/pharmacist (ASK DOCTOR/PHARMACIST)

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin
Dosage & Administration (DOSAGE & ADMINISTRATION)

Directions

  • do not use more than directed

Adults and children: (12 years and over) Take 2 tablets every 6 hours. Do not take more than 8 tablets in 24 hours.

Children under 12 years: Ask a doctor

Other Safety Information (OTHER SAFETY INFORMATION)

Other information

  • store at room temperature 59º-86ºF (15º-30ºC)
  • tamper evident sealed packets
  • do not use any opened or torn packets
  • avoid excessive heat and humidity
Pregnancy Or Breast Feeding (PREGNANCY OR BREAST FEEDING)

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

Keep Out of Reach of Children (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.

Principal Display Panel – 250 Tablet Box Label (PRINCIPAL DISPLAY PANEL – 250 Tablet Box Label)

ProvisionPlus

Sinu-Phen Plus

Sinus Pain & Pressure Relief

Fast Relief of:

  • Fever
  • Nasal Congestion
  • Body Aches
  • Sinus Pain

250 tablets

2 Per Packet


Advanced Ingredient Data


Raw Label Data

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