Rite Aid 44-677

Rite Aid 44-677
SPL v8
SPL
SPL Set ID 627beff0-6716-41b3-a69d-8e7a7793cf63
Route
ORAL
Published
Effective Date 2025-08-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Dextromethorphan (10 mg) Doxylamine (6.25 mg) Phenylephrine (5 mg)
Inactive Ingredients
Ferrosoferric Oxide Starch, Corn Crospovidone, Unspecified D&c Yellow No. 10 Aluminum Lake Fd&c Blue No. 1 Aluminum Lake Fd&c Yellow No. 6 Aluminum Lake Magnesium Stearate 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;677 Shape: oval Color: green Size: 19 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-12-10

Description

Acetaminophen 325 mg Dextromethorphan HBr 10 mg Doxylamine succinate 6.25 mg Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer Cough suppressant Antihistamine Nasal decongestant


Medication Information

Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant

Description

Acetaminophen 325 mg Dextromethorphan HBr 10 mg Doxylamine succinate 6.25 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 to help you sleep
    • runny nose and sneezing
    • cough due to minor throat and bronchial irritation
  • reduces swelling of nasal passages
  • promotes nasal and/or sinus drainage
  • temporarily restores freer breathing through the nose
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

black iron oxide, corn starch, crospovidone, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, 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

NDC 11822-0677-8

Compare to the active ingredients in

Vicks® NyQuiVapoCOO

SEVERE COLD & FLU + CONGESTION*

MAXIMUM STRENGTH

SEVERE NIGHTTIME

COLD & FLU
RELIEF

DEXTROMETHORPHAN HBr - COUGH SUPPRESSANT

DOXYLAMINE SUCCINATE -
ANTIHISTAMINE

PHENYLEPHRINE HCl -
NASAL DECONGESTANT

Relieves headache, fever, sore throat,

minor aches & pains, nasal/sinus congestion

& sinus pressure, sneezing, runny nose, cough

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® NyQuil® VapoCOOL®

SEVERE COLD & FLU + CONGESTION.

50844 REV0722C67708

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 44-677


When Using This Product
  • do not exceed recommended dosage
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic beverages
  • be careful when driving a motor vehicle or operating machinery
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.

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

  • heart disease
  • glaucoma
  • high blood pressure

  • difficulty in urination due to enlargement of the prostate gland

  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough that occurs with too much phlegm (mucus)
Active Ingredients (in Each Caplet)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Doxylamine succinate 6.25 mg

Phenylephrine HCl 5 mg

Ask A Doctor Or Pharmacist Before Use If You Are
  • taking sedatives or tranquilizers

  • 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 to help you sleep
    • runny nose and sneezing
    • cough due to minor throat and bronchial irritation
  • reduces swelling of nasal passages
  • promotes nasal and/or sinus drainage
  • temporarily restores freer breathing through the nose
Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

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)

black iron oxide, corn starch, crospovidone, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, 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 (Principal display panel)

NDC 11822-0677-8

Compare to the active ingredients in

Vicks® NyQuiVapoCOO

SEVERE COLD & FLU + CONGESTION*

MAXIMUM STRENGTH

SEVERE NIGHTTIME

COLD & FLU
RELIEF

DEXTROMETHORPHAN HBr - COUGH SUPPRESSANT

DOXYLAMINE SUCCINATE -
ANTIHISTAMINE

PHENYLEPHRINE HCl -
NASAL DECONGESTANT

Relieves headache, fever, sore throat,

minor aches & pains, nasal/sinus congestion

& sinus pressure, sneezing, runny nose, cough

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® NyQuil® VapoCOOL®

SEVERE COLD & FLU + CONGESTION.

50844 REV0722C67708

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 44-677


When Using This Product (When using this product)
  • do not exceed recommended dosage
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic beverages
  • be careful when driving a motor vehicle or operating machinery
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.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • liver disease
  • diabetes
  • thyroid disease

  • heart disease
  • glaucoma
  • high blood pressure

  • difficulty in urination due to enlargement of the prostate gland

  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough that occurs with too much phlegm (mucus)
Active Ingredients (in Each Caplet) (Active ingredients (in each caplet))

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Doxylamine succinate 6.25 mg

Phenylephrine HCl 5 mg

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

  • taking the blood thinning drug warfarin


Advanced Ingredient Data


Raw Label Data

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