Buckleys 44-005

SPL v5

SPL

SPL Set ID a81fc021-9a9f-4cec-a1a6-73e3f983b78d

Route

ORAL

Published

Effective Date 2025-12-12

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (650 mg) Dextromethorphan (20 mg) Guaifenesin (400 mg) Phenylephrine (10 mg)

Inactive Ingredients

Anhydrous Citric Acid Fd&c Blue No. 1 Fd&c Red No. 40 Glycerin Polyethylene Glycol, Unspecified Propylene Glycol Water Sodium Benzoate Trisodium Citrate Dihydrate Sodium Metabisulfite Sorbitol Sucralose

Identifiers & Packaging

Pill Appearance

Color: blue

Marketing Status

OTC MONOGRAPH DRUG Active Since 2022-02-23

Description

Acetaminophen 650 mg Dextromethorphan HBr 20 mg Guaifenesin 400 mg Phenylephrine HCl 10 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 650 mg Dextromethorphan HBr 20 mg Guaifenesin 400 mg Phenylephrine HCl 10 mg

Uses

temporarily relieves these common cold and flu symptoms:
- minor aches and pains
- sinus congestion and pressure
- stuffy nose
- nasal congestion
- sore throat
- cough
- headache
temporarily promotes nasal and/or sinus drainage
temporarily reduces fever
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 6 doses in any 24-hour period
mL = milliliter
only use the dose cup provided
dose as follows or as directed by a doctor
adults and children 12 years and over: 20 mL in dosing cup provided every 4 hours
children under 12 years: 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

each 20 mL contains: sodium 10 mg
store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
use by expiration date on package

Inactive Ingredients

anhydrous citric acid, FD&C blue #1, FD&C red #40, flavors, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sodium metabisulfite, sorbitol, sucralose

Questions Or Comments?

1-888-779-2877 M-F 9AM-5PM EST

Principal Display Panel

Belmora LLC

NDC 27854-299-00

MAXIMUM STRENGTH

Buckleys

COMPLETE COLD RELIEF

ACETAMINOPHEN -

PAIN RELIEVER/FEVER REDUCER

DEXTROMETHORPHAN HBr - COUGH SUPPRESSANT

GUAIFENESIN - EXPECTORANT

PHENYLEPHRINE HCl - NASAL DECONGESTANT

RELIEVES:

✓HEADACHE, FEVER & SORE THROAT

✓SINUS PRESSURE AND CONGESTION

✓CONTROLS COUGH, THINS & LOOSENS MUCUS

AGES 12 & OVER

F-005-45 REV A

6 FL OZ (177 mL)

MIXED BERRY FLAVORED

TAMPER EVIDENT: DO NOT USE IF IMPRINTED

SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

Distributed by: Belmora LLC, 3033 Wilson Blvd. Suite 700

Arlington, VA 22201 50844 REV0523A00545

Buckleys 44-005

When Using This Product

do not exceed recommended dosage.

Stop Use and Ask A Doctor If

pain, nasal congestion, or cough gets worse or lasts more than 7 days
new symptoms occur
nervousness, dizziness, or sleeplessness occur
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.
redness or swelling is present

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 20 Ml)

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Phenylephrine HCl 10 mg

Ask A Doctor Before Use If You Have

cough that occurs with too much phlegm (mucus)
liver disease
thyroid disease
heart disease
difficulty in urination due to enlargement of the prostate gland
high blood pressure
diabetes
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 these common cold and flu symptoms:
- minor aches and pains
- sinus congestion and pressure
- stuffy nose
- nasal congestion
- sore throat
- cough
- headache
temporarily promotes nasal and/or sinus drainage
temporarily reduces fever
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 6 doses in any 24-hour period
mL = milliliter
only use the dose cup provided
dose as follows or as directed by a doctor
adults and children 12 years and over: 20 mL in dosing cup provided every 4 hours
children under 12 years: do not use

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 20 mL contains: sodium 10 mg
store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
use by expiration date on package

Inactive Ingredients (Inactive ingredients)

Questions Or Comments? (Questions or comments?)

1-888-779-2877 M-F 9AM-5PM EST

Principal Display Panel (Principal display panel)

Belmora LLC

NDC 27854-299-00

MAXIMUM STRENGTH

Buckleys

COMPLETE COLD RELIEF

ACETAMINOPHEN -

PAIN RELIEVER/FEVER REDUCER

DEXTROMETHORPHAN HBr - COUGH SUPPRESSANT

GUAIFENESIN - EXPECTORANT

PHENYLEPHRINE HCl - NASAL DECONGESTANT

RELIEVES:

✓HEADACHE, FEVER & SORE THROAT

✓SINUS PRESSURE AND CONGESTION

✓CONTROLS COUGH, THINS & LOOSENS MUCUS

AGES 12 & OVER

F-005-45 REV A

6 FL OZ (177 mL)

MIXED BERRY FLAVORED

TAMPER EVIDENT: DO NOT USE IF IMPRINTED

SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

Distributed by: Belmora LLC, 3033 Wilson Blvd. Suite 700

Arlington, VA 22201 50844 REV0523A00545

Buckleys 44-005

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)

pain, nasal congestion, or cough gets worse or lasts more than 7 days
new symptoms occur
nervousness, dizziness, or sleeplessness occur
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.
redness or swelling is present

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.)

Active Ingredients (in Each 20 Ml) (Active ingredients (in each 20 mL))

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Phenylephrine HCl 10 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

cough that occurs with too much phlegm (mucus)
liver disease
thyroid disease
heart disease
difficulty in urination due to enlargement of the prostate gland
high blood pressure
diabetes
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.

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves these common cold and flu symptoms: minor aches and pains sinus congestion and pressure stuffy nose nasal congestion sore throat cough headache temporarily promotes nasal and/or sinus drainage temporarily reduces fever 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 6 doses in any 24-hour period mL = milliliter only use the dose cup provided dose as follows or as directed by a doctor adults and children 12 years and over: 20 mL in dosing cup provided every 4 hours children under 12 years: 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": "each 20 mL contains: sodium 10 mg store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) use by expiration date on package", "Inactive ingredients": "anhydrous citric acid, FD&C blue #1, FD&C red #40, flavors, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sodium metabisulfite, sorbitol, sucralose", "Questions or comments?": "1-888-779-2877 M-F 9AM-5PM EST", "Principal display panel": "Belmora LLC NDC 27854-299-00 MAXIMUM STRENGTH Buckleys COMPLETE COLD RELIEF ACETAMINOPHEN - PAIN RELIEVER/FEVER REDUCER DEXTROMETHORPHAN HBr - COUGH SUPPRESSANT GUAIFENESIN - EXPECTORANT PHENYLEPHRINE HCl - NASAL DECONGESTANT RELIEVES: ✓HEADACHE, FEVER & SORE THROAT ✓SINUS PRESSURE AND CONGESTION ✓CONTROLS COUGH, THINS & LOOSENS MUCUS AGES 12 & OVER F-005-45 REV A 6 FL OZ (177 mL) MIXED BERRY FLAVORED TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING PARENTS: Learn about teen medicine abuse www.StopMedicineAbuse.org Distributed by: Belmora LLC, 3033 Wilson Blvd. Suite 700 Arlington, VA 22201 50844 REV0523A00545 Buckleys 44-005", "When using this product": "do not exceed recommended dosage.", "Stop use and ask a doctor if": "pain, nasal congestion, or cough gets worse or lasts more than 7 days new symptoms occur nervousness, dizziness, or sleeplessness occur 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. redness or swelling is present", "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 20 mL)": "Acetaminophen 650 mg Dextromethorphan HBr 20 mg Guaifenesin 400 mg Phenylephrine HCl 10 mg", "Ask a doctor before use if you have": "cough that occurs with too much phlegm (mucus) liver disease thyroid disease heart disease difficulty in urination due to enlargement of the prostate gland high blood pressure diabetes 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."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:39.707371 · Updated: 2026-03-14T23:11:22.461750