Rite Aid 44-558-delisted

Rite Aid 44-558-delisted
SPL v27
SPL
SPL Set ID 8a0a8abf-0a41-44f8-8f4f-aec68a0fa0c5
Route
ORAL
Published
Effective Date 2025-01-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Phenylephrine (5 mg)
Inactive Ingredients
Starch, Corn Croscarmellose Sodium Crospovidone, Unspecified D&c Yellow No. 10 Fd&c Blue No. 1 Fd&c Red No. 40 Fd&c Yellow No. 6 Gelatin, Unspecified Hydroxypropyl Cellulose, Unspecified Hypromellose, Unspecified Ferrosoferric Oxide Ferric Oxide Red Ferric Oxide Yellow Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Povidone, Unspecified Propylene Glycol Shellac Silicon Dioxide Stearic Acid Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: L;8 Shape: oval Color: red Color: green Size: 19 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2008-03-17 Until 2026-11-22

Description

Acetaminophen 325 mg Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer Nasal decongestant


Medication Information

Purpose

Pain reliever/fever reducer

Nasal decongestant

Description

Acetaminophen 325 mg Phenylephrine HCl 5 mg

Uses
  • temporarily relieves these symptoms associated with hay fever or other respiratory allergies, and the common cold:

    • headache
    • sinus congestion and pressure
    • minor aches and pains
    • nasal congestion
  • helps decongest sinus openings and passages
  • promotes sinus drainage
  • helps clear nasal passages
  • temporarily reduces fever

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.

Directions
  • do not take more than directed

  • adults and children 12 years and over
    • take 2 gelcaps every 4 hours
    • do not take more than 10 gelcaps in 24 hours
  • children under 12 years: ask a doctor


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

Other Information
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • avoid high humidity

  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number 
Inactive Ingredients

corn starch, croscarmellose sodium, crospovidone, D&C yellow #10, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, propylene glycol, shellac glaze, silicon dioxide, stearic acid, titanium dioxide

Questions Or Comments?

1-800-426-9391

Principal Display Panel

NDC 11822-0588-8

Compare to the active ingredients in

Tylenol® SINUS + HEADACHE Day*

DAYTIME SINUS

CONGESTION

& PAIN
RELIEF

ACETAMINOPHEN 325 mg

PHENYLEPHRINE HCl 5 mg

PAIN RELIEVER / FEVER REDUCER

NASAL DECONGESTANT

DAYTIME NON-DROWSY

Relieves headache, nasal congestion,

sinus congestion & pressure

ACTUAL SIZE

24

GELCAPS

TAMPER EVIDENT: DO NOT USE IF

PACKAGE IS OPENED OR IF BLISTER

UNIT IS TORN, BROKEN OR SHOWS

ANY SIGNS OF TAMPERING

*This product is not manufactured or distributed by Kenvue Inc.,

owner of the registered trademark Tylenol® SINUS + HEADACHE Day.

50844      REV0422F55808

DISTRIBUTED BY:

RITE AID, 200 NEWBERRY COMMONS

ETTERS, PA 17319 www.riteaid.com

SATISFACTION

GUARANTEE

If you're not satisfied, we'll

happily refund your money.

Rite Aid 44-558
When Using This Product

do not exceed recommended dosage.

Stop Use and Ask A Doctor If
  • nervousness, dizziness, or sleeplessness occur
  • pain or nasal congestion gets worse or lasts more than 7 days
  • new symptoms occur
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present

These could be signs of a serious condition.

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Active Ingredients (in Each Gelcap)

Acetaminophen 325 mg

Phenylephrine HCl 5 mg

Ask A Doctor Before Use If You Have
  • liver disease
  • thyroid disease
  • heart disease
  • diabetes
  • difficulty in urination due to enlargement of the prostate gland
  • high blood pressure

Ask A Doctor Or Pharmacist Before Use If You Are

taking the blood thinning drug warfarin.


Structured Label Content

Uses
  • temporarily relieves these symptoms associated with hay fever or other respiratory allergies, and the common cold:

    • headache
    • sinus congestion and pressure
    • minor aches and pains
    • nasal congestion
  • helps decongest sinus openings and passages
  • promotes sinus drainage
  • helps clear nasal passages
  • temporarily reduces fever

Purpose

Pain reliever/fever reducer

Nasal decongestant

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.

Directions
  • do not take more than directed

  • adults and children 12 years and over
    • take 2 gelcaps every 4 hours
    • do not take more than 10 gelcaps in 24 hours
  • children under 12 years: ask a doctor


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

Other Information (Other information)
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • avoid high humidity

  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number 
Inactive Ingredients (Inactive ingredients)

corn starch, croscarmellose sodium, crospovidone, D&C yellow #10, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, propylene glycol, shellac glaze, silicon dioxide, stearic acid, titanium dioxide

Questions Or Comments? (Questions or comments?)

1-800-426-9391

Principal Display Panel

NDC 11822-0588-8

Compare to the active ingredients in

Tylenol® SINUS + HEADACHE Day*

DAYTIME SINUS

CONGESTION

& PAIN
RELIEF

ACETAMINOPHEN 325 mg

PHENYLEPHRINE HCl 5 mg

PAIN RELIEVER / FEVER REDUCER

NASAL DECONGESTANT

DAYTIME NON-DROWSY

Relieves headache, nasal congestion,

sinus congestion & pressure

ACTUAL SIZE

24

GELCAPS

TAMPER EVIDENT: DO NOT USE IF

PACKAGE IS OPENED OR IF BLISTER

UNIT IS TORN, BROKEN OR SHOWS

ANY SIGNS OF TAMPERING

*This product is not manufactured or distributed by Kenvue Inc.,

owner of the registered trademark Tylenol® SINUS + HEADACHE Day.

50844      REV0422F55808

DISTRIBUTED BY:

RITE AID, 200 NEWBERRY COMMONS

ETTERS, PA 17319 www.riteaid.com

SATISFACTION

GUARANTEE

If you're not satisfied, we'll

happily refund your money.

Rite Aid 44-558
When Using This Product (When using this product)

do not exceed recommended dosage.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • nervousness, dizziness, or sleeplessness occur
  • pain or nasal congestion gets worse or lasts more than 7 days
  • new symptoms occur
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present

These could be signs of a serious condition.

If Pregnant 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.)

In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Active Ingredients (in Each Gelcap) (Active ingredients (in each gelcap))

Acetaminophen 325 mg

Phenylephrine HCl 5 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • liver disease
  • thyroid disease
  • heart disease
  • diabetes
  • difficulty in urination due to enlargement of the prostate gland
  • high blood pressure

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking the blood thinning drug warfarin.


Advanced Ingredient Data


Raw Label Data

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