Dollar General 44-617 Sppc

SPL v4

SPL

SPL Set ID 259b6f12-50c0-4e7a-9a44-bdf7e9a20a56

Route

ORAL

Published

Effective Date 2025-06-07

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 Polyvinyl Alcohol, Unspecified Povidone, Unspecified Silicon Dioxide Sodium Starch Glycolate Type A Potato Stearic Acid Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance

Imprint: 44;617 Shape: oval Color: red 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 Cough suppressant Expectorant Nasal decongestant

Medication Information

Purpose

Pain reliever

Cough suppressant

Expectorant

Nasal decongestant

Description

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

Uses

temporarily relieves:
- nasal congestion
- headache
- sinus congestion and pressure
- minor aches and pains
- cough due to the common cold
helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
temporarily promotes nasal and/or sinus drainage

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.

Directions

do not take more than directed
do not take more than 12 caplets in any 24-hour period
adults and children 12 years and over: take 2 caplets 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 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

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

Questions Or Comments?

1-888-309-9030

Principal Display Panel

DG™ | health

Compare to active

ingredients of

Maximum Strength

Mucinex^® SINUS-MAX^®

Pressure, Pain & Cough*

Maximum Strength

Sinus Pressure,

Pain & Cough

Acetaminophen • Pain Reliever

Dextromethorphan HBr • Cough Suppressant

Guaifenesin • Expectorant

Phenylephrine HCl • Nasal Decongestant

20 Caplets

Actual Caplet Size

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS

OPENED OR IF BLISTER UNIT IS TORN, BROKEN

OR SHOWS ANY SIGNS OF TAMPERING

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

*This product is not manufactured or distributed by RB

Health (US) LLC, owner of the registered trademark

Maximum Strength Mucinex^® SINUS-MAX^® Pressure,

Pain & Cough.

50844 REV0823A61709

DISTRIBUTED BY

OLD EAST MAIN CO.

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072

100%

Satisfaction

Guaranteed!

(888) 309-9030

Dollar General 44-617

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

heart disease
diabetes
thyroid disease
persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
liver disease
high blood pressure
cough that occurs with too much phlegm (mucus)
difficulty in urination due to enlargement of the prostate gland

Ask A Doctor Or Pharmacist Before Use If You Are

taking the blood thinning drug warfarin.

Structured Label Content

Uses

temporarily relieves:
- nasal congestion
- headache
- sinus congestion and pressure
- minor aches and pains
- cough due to the common cold
helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
temporarily promotes nasal and/or sinus drainage

Purpose

Pain reliever

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.

Directions

do not take more than directed
do not take more than 12 caplets in any 24-hour period
adults and children 12 years and over: take 2 caplets 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 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)

Questions Or Comments? (Questions or comments?)

1-888-309-9030

Principal Display Panel (Principal display panel)

DG™ | health

Compare to active

ingredients of

Maximum Strength

Mucinex^® SINUS-MAX^®

Pressure, Pain & Cough*

Maximum Strength

Sinus Pressure,

Pain & Cough

Acetaminophen • Pain Reliever

Dextromethorphan HBr • Cough Suppressant

Guaifenesin • Expectorant

Phenylephrine HCl • Nasal Decongestant

20 Caplets

Actual Caplet Size

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS

OPENED OR IF BLISTER UNIT IS TORN, BROKEN

OR SHOWS ANY SIGNS OF TAMPERING

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

*This product is not manufactured or distributed by RB

Health (US) LLC, owner of the registered trademark

Maximum Strength Mucinex^® SINUS-MAX^® Pressure,

Pain & Cough.

50844 REV0823A61709

DISTRIBUTED BY

OLD EAST MAIN CO.

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072

100%

Satisfaction

Guaranteed!

(888) 309-9030

Dollar General 44-617

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.)

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)

heart disease
diabetes
thyroid disease
persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
liver disease
high blood pressure
cough that occurs with too much phlegm (mucus)
difficulty in urination due to enlargement of the prostate gland

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: nasal congestion headache sinus congestion and pressure minor aches and pains cough due to the common cold helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive temporarily promotes nasal and/or sinus drainage", "Purpose": "Pain reliever 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.", "Directions": "do not take more than directed do not take more than 12 caplets in any 24-hour period adults and children 12 years and over: take 2 caplets 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 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": "corn starch, crospovidone, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide", "Questions or comments?": "1-888-309-9030", "Principal display panel": "DG™ | health Compare to active ingredients of Maximum Strength Mucinex ® SINUS-MAX ® Pressure, Pain & Cough* Maximum Strength Sinus Pressure, Pain & Cough Acetaminophen • Pain Reliever Dextromethorphan HBr • Cough Suppressant Guaifenesin • Expectorant Phenylephrine HCl • Nasal Decongestant 20 Caplets Actual Caplet Size TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING PARENTS: Learn about teen medicine abuse www.StopMedicineAbuse.org *This product is not manufactured or distributed by RB Health (US) LLC, owner of the registered trademark Maximum Strength Mucinex ® SINUS-MAX ® Pressure, Pain & Cough. 50844 REV0823A61709 DISTRIBUTED BY OLD EAST MAIN CO. 100 MISSION RIDGE GOODLETTSVILLE, TN 37072 100% Satisfaction Guaranteed! (888) 309-9030 Dollar General 44-617", "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": "heart disease diabetes thyroid disease persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema liver disease high blood pressure cough that occurs with too much phlegm (mucus) difficulty in urination due to enlargement of the prostate gland", "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: 2026-02-15T12:06:15.499634 · Updated: 2026-03-14T23:08:56.104871