c66e0b52-5531-4a84-ae90-8a26d27df1ec
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
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
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:08:23.222331 · Updated: 2026-03-14T23:12:36.957432