Kirkland 44-795796-81

Kirkland 44-795796-81
SPL v4
SPL
SPL Set ID 5180abbc-c6c4-4b82-b6e7-4504e3bcff0f
Route
ORAL
Published
Effective Date 2025-04-26
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) Doxylamine (6.25 mg)
Inactive Ingredients
Benzyl Alcohol 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 Propylene Glycol Silicon Dioxide Sodium Starch Glycolate Type A Potato Stearic Acid Sucralose Talc Titanium Dioxide Ferrosoferric Oxide D&c Yellow No. 10 Aluminum Lake Fd&c Blue No. 1 Aluminum Lake

Identifiers & Packaging

Pill Appearance
Imprint: 44;796 Shape: oval Color: orange Color: green Size: 19 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-06-30

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:
    • nasal congestion
    • sore throat
    • minor aches and pains
    • headache
    • sinus congestion and pressure
    • cough due to minor throat and bronchial irritation
    • reduces swelling of nasal passages
  • temporarily reduces fever
  • 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
  • see end flap for expiration date and lot number
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
Inactive Ingredients

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

Questions Or Comments?

1-800-426-9391

Principal Display Panel

KIRKLAND

Signature

COMPARE TO VICKS® DAYQUIL® & NYQUIL® VAPOCOOL®

SEVERE COLD & FLU + CONGESTION

active ingredients*

NDC 63981-795-81

ITM. / ART. 1729556

COOL BLAST

SEVERE COLD & FLU

PLUS CONGESTION

Acetaminophen 325 mg,

Dextromethorphan HBr 10 mg, Guaifenesin 200 mg,

Phenylephrine HCl 5 mg

Pain Reliever • Fever Reducer • Cough Suppressant

Expectorant • Nasal Decongestant

Relieves:

Headache, Fever, Sore Throat,

Minor Aches & Pains

Chest Congestion, Thins &

Loosens Mucus

Nasal Congestion, Sinus Pressure

Cough

Actual

Size

112 DAY COATED CAPLETS

Acetaminophen 325 mg,

Dextromethorphan HBr 10 mg, Doxylamine succinate 6.25 mg,

Phenylephrine HCl 5 mg

Pain Reliever • Fever Reducer • Cough Suppressant

Antihistamine • Nasal Decongestant

Relieves:

Headache, Fever, Sore Throat,

Minor Aches & Pains

Nasal Congestion,

Sinus Pressure

Sneezing, Runny Nose

Cough

Actual

Size

56 NIGHT COATED CAPLETS

168

TOTAL CAPLETS

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER

UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

Do Not Take Daytime and Nighttime Products at the Same Time.

*This product is not manufactured or distributed by The Procter & Gamble Company, owner of the

registered trademark Vicks® DayQuil® and NyQuil® VapoCOOL® Severe Cold & Flu + Congestion.

50844        REV0223A79579681

Manufactured by: LNK INTERNATIONAL, INC.

60 Arkay Drive, Hauppauge, NY 11788 USA

For: Costco Wholesale Corporation

999 Lake Drive, Issaquah, WA 98027 USA

www.costco.com

23V08014a

Kirkland 44-795796
When Using This Product

do not exceed recommended dosage.

Stop Use and Ask A Doctor If
  • nervousness, dizziness, or sleeplessness occur
  • redness or swelling is present
  • new symptoms occur
  • pain, nasal congestion, or cough gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
  • 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
  • diabetes
  • thyroid disease
  • heart disease
  • high blood pressure
  • difficulty in urination due to enlargement of the prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough that occurs with too much phlegm (mucus)
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:
    • nasal congestion
    • sore throat
    • minor aches and pains
    • headache
    • sinus congestion and pressure
    • cough due to minor throat and bronchial irritation
    • reduces swelling of nasal passages
  • temporarily reduces fever
  • 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
  • see end flap for expiration date and lot number
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

1-800-426-9391

Principal Display Panel (Principal display panel)

KIRKLAND

Signature

COMPARE TO VICKS® DAYQUIL® & NYQUIL® VAPOCOOL®

SEVERE COLD & FLU + CONGESTION

active ingredients*

NDC 63981-795-81

ITM. / ART. 1729556

COOL BLAST

SEVERE COLD & FLU

PLUS CONGESTION

Acetaminophen 325 mg,

Dextromethorphan HBr 10 mg, Guaifenesin 200 mg,

Phenylephrine HCl 5 mg

Pain Reliever • Fever Reducer • Cough Suppressant

Expectorant • Nasal Decongestant

Relieves:

Headache, Fever, Sore Throat,

Minor Aches & Pains

Chest Congestion, Thins &

Loosens Mucus

Nasal Congestion, Sinus Pressure

Cough

Actual

Size

112 DAY COATED CAPLETS

Acetaminophen 325 mg,

Dextromethorphan HBr 10 mg, Doxylamine succinate 6.25 mg,

Phenylephrine HCl 5 mg

Pain Reliever • Fever Reducer • Cough Suppressant

Antihistamine • Nasal Decongestant

Relieves:

Headache, Fever, Sore Throat,

Minor Aches & Pains

Nasal Congestion,

Sinus Pressure

Sneezing, Runny Nose

Cough

Actual

Size

56 NIGHT COATED CAPLETS

168

TOTAL CAPLETS

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER

UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

Do Not Take Daytime and Nighttime Products at the Same Time.

*This product is not manufactured or distributed by The Procter & Gamble Company, owner of the

registered trademark Vicks® DayQuil® and NyQuil® VapoCOOL® Severe Cold & Flu + Congestion.

50844        REV0223A79579681

Manufactured by: LNK INTERNATIONAL, INC.

60 Arkay Drive, Hauppauge, NY 11788 USA

For: Costco Wholesale Corporation

999 Lake Drive, Issaquah, WA 98027 USA

www.costco.com

23V08014a

Kirkland 44-795796
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
  • redness or swelling is present
  • new symptoms occur
  • pain, nasal congestion, or cough gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
  • 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
  • diabetes
  • thyroid disease
  • heart disease
  • high blood pressure
  • difficulty in urination due to enlargement of the prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough that occurs with too much phlegm (mucus)
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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