1123b-qch-2021-0303
fe0cf681-f42c-430c-8429-f7ba4bc5a976
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Drug Facts
Medication Information
Description
Drug Facts
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
Section 42229-5
Drug Facts
Section 50565-1
Keep out of reach of children.
Section 50566-9
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.
Section 50567-7
When using this product do not exceed recommended dosage
Section 50568-5
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin
Section 50569-3
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
Section 50570-1
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
Section 53414-9
If pregnant or breast-feeding, ask a health professional before use.
Section 55105-1
| Active ingredients (in each caplet) | Purpose |
|---|---|
| Acetaminophen 325 mg | Pain reliever/fever reducer |
| Phenylephrine HCl 5 mg | Nasal decongestant |
Directions
- do not take more than directed (see overdose warning)
| adults and children 12 years and over |
|
| children under 12 years |
|
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.
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
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.
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, corn starch, 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
QUALITY CHOICE®
NDC 63868-582-24
†Compare to Active Ingredients in Tylenol® Sinus + Headache
For Adults, Non-Drowsy
Sinus + Headache
Pain Reliever | Fever Reducer, Nasal Decongestant
Acetaminophen, Phenylephrine HCl
For Relief of:
Sinus Headache
Sinus Pressure
Nasal Congestion
DAYTIME
24 COOL TASTE CAPLETS
Actual Size
Structured Label Content
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
Section 42229-5 (42229-5)
Drug Facts
Section 50565-1 (50565-1)
Keep out of reach of children.
Section 50566-9 (50566-9)
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.
Section 50567-7 (50567-7)
When using this product do not exceed recommended dosage
Section 50568-5 (50568-5)
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin
Section 50569-3 (50569-3)
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
Section 50570-1 (50570-1)
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
Section 53414-9 (53414-9)
If pregnant or breast-feeding, ask a health professional before use.
Section 55105-1 (55105-1)
| Active ingredients (in each caplet) | Purpose |
|---|---|
| Acetaminophen 325 mg | Pain reliever/fever reducer |
| Phenylephrine HCl 5 mg | Nasal decongestant |
Directions
- do not take more than directed (see overdose warning)
| adults and children 12 years and over |
|
| children under 12 years |
|
Allergy Alert (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.
Liver Warning (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
Overdose Warning (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.
Other Information (Other information)
- store between 20-25°C (68-77°F) in a dry place
- retain carton for complete product information and warnings
Inactive Ingredients (Inactive ingredients)
acesulfame potassium, colloidal silicon dioxide, corn starch, 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 (PRINCIPAL DISPLAY PANEL)
QUALITY CHOICE®
NDC 63868-582-24
†Compare to Active Ingredients in Tylenol® Sinus + Headache
For Adults, Non-Drowsy
Sinus + Headache
Pain Reliever | Fever Reducer, Nasal Decongestant
Acetaminophen, Phenylephrine HCl
For Relief of:
Sinus Headache
Sinus Pressure
Nasal Congestion
DAYTIME
24 COOL TASTE CAPLETS
Actual Size
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:04:35.963022 · Updated: 2026-03-14T23:05:28.061539