Rite Aid 44-640

Rite Aid 44-640
SPL v9
SPL
SPL Set ID 5700ef26-ffa6-480a-bf36-bd5111799e9b
Route
ORAL
Published
Effective Date 2025-05-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Dextromethorphan (10 mg) Guaifenesin (200 mg) Phenylephrine (5 mg)
Inactive Ingredients
Starch, Corn Crospovidone, Unspecified Fd&c Red No. 40 Aluminum Lake Fd&c Yellow No. 6 Aluminum Lake Magnesium Stearate Maltodextrin Microcrystalline Cellulose Polyethylene Glycol, Unspecified Polysorbate 80 Polyvinyl Alcohol, Unspecified Povidone, Unspecified Silicon Dioxide Sodium Starch Glycolate Type A Potato Stearic Acid Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: 44;640 Shape: oval Color: orange Size: 19 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-11-25

Description

Acetaminophen 325 mg Dextromethorphan HBr 10 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant


Medication Information

Purpose

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Description

Acetaminophen 325 mg Dextromethorphan HBr 10 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg

Uses
  • temporarily relieves common cold and flu symptoms:
    • minor aches and pains
    • sinus congestion and pressure

    • sore throat
    • fever
    • headache
    • nasal congestion

    • cough due to minor throat and bronchial irritation

  • reduces swelling of nasal passages

  • temporarily restores freer breathing through the nose

  • promotes nasal and/or sinus drainage
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
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:

  • blisters
  • rash
  • skin reddening

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

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Directions
  • do not take more than directed

  • do not take more than 8 caplets in 24 hours

  • adults and children 12 years and over: take 2 caplets with water every 4 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
  • each caplet contains: sodium 3 mg
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • see end flap for expiration date and lot number
Inactive Ingredients

corn starch, crospovidone, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polysorbate 80, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide

Questions Or Comments?

1-800-426-9391

Principal Display Panel

11822-0640-8

Compare to the active

ingredients in Vicks®

DayQuil® VapoCOOL®

SEVERE COLD & FLU

+ CONGESTION*  
           

MAXIMUM STRENGTH

SEVERE

COLD & FLU RELIEF

DAY

ACETAMINOPHEN

PAIN RELIEVER / FEVER REDUCER

DEXTROMETHORPHAN HBr

COUGH SUPPRESSANT

GUAIFENESIN • PHENYLEPHRINE HCl

EXPECTORANT • NASAL DECONGESTANT

Temporarily relieves headache, fever,

sore throat, minor aches & pains, nasal/sinus

congestion & sinus pressure,

cough, chest congestion

ACTUAL SIZE

24

CAPLETS

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 The Procter & Gamble

Company, owner of the registered trademark Vicks® DayQuil® VapoCOOL®

SEVERE COLD & FLU + CONGESTION.

50844      REV0722C64008

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.

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

Rite Aid 44-640
When Using This Product

do not exceed recommended dosage.

Stop Use and Ask A Doctor If
  • nervousness, dizziness, or sleeplessness occur

  • pain, nasal congestion, or cough 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

  • cough comes back or occurs with rash or headache that lasts. 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 Caplet)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Ask A Doctor Before Use If You Have
  • liver disease
  • thyroid disease
  • diabetes

  • heart disease
  • high blood pressure

  • difficulty in urination due to enlargement of the prostate gland 
  • cough that occurs with too much phlegm (mucus)

  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Ask A Doctor Or Pharmacist Before Use If You Are

taking the blood thinning drug warfarin.


Structured Label Content

Uses
  • temporarily relieves common cold and flu symptoms:
    • minor aches and pains
    • sinus congestion and pressure

    • sore throat
    • fever
    • headache
    • nasal congestion

    • cough due to minor throat and bronchial irritation

  • reduces swelling of nasal passages

  • temporarily restores freer breathing through the nose

  • promotes nasal and/or sinus drainage
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Purpose

Pain reliever/fever reducer

Cough suppressant

Expectorant

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:

  • blisters
  • rash
  • skin reddening

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

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Directions
  • do not take more than directed

  • do not take more than 8 caplets in 24 hours

  • adults and children 12 years and over: take 2 caplets with water every 4 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)
  • each caplet contains: sodium 3 mg
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • see end flap for expiration date and lot number
Inactive Ingredients (Inactive ingredients)

corn starch, crospovidone, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polysorbate 80, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide

Questions Or Comments? (Questions or comments?)

1-800-426-9391

Principal Display Panel

11822-0640-8

Compare to the active

ingredients in Vicks®

DayQuil® VapoCOOL®

SEVERE COLD & FLU

+ CONGESTION*  
           

MAXIMUM STRENGTH

SEVERE

COLD & FLU RELIEF

DAY

ACETAMINOPHEN

PAIN RELIEVER / FEVER REDUCER

DEXTROMETHORPHAN HBr

COUGH SUPPRESSANT

GUAIFENESIN • PHENYLEPHRINE HCl

EXPECTORANT • NASAL DECONGESTANT

Temporarily relieves headache, fever,

sore throat, minor aches & pains, nasal/sinus

congestion & sinus pressure,

cough, chest congestion

ACTUAL SIZE

24

CAPLETS

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 The Procter & Gamble

Company, owner of the registered trademark Vicks® DayQuil® VapoCOOL®

SEVERE COLD & FLU + CONGESTION.

50844      REV0722C64008

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.

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

Rite Aid 44-640
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, nasal congestion, or cough 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

  • cough comes back or occurs with rash or headache that lasts. 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 Caplet) (Active ingredients (in each caplet))

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 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
  • diabetes

  • heart disease
  • high blood pressure

  • difficulty in urination due to enlargement of the prostate gland 
  • cough that occurs with too much phlegm (mucus)

  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

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.


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Raw Label Data

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