Drug Facts

Drug Facts

SPL v4

SPL

SPL Set ID aaccafe6-2e76-4023-a5d8-bcec27f60f08

Route

ORAL

Published

Effective Date 2024-03-22

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

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

Inactive Ingredients

Anhydrous Citric Acid Edetate Disodium Fd&c Blue No. 1 Fd&c Red No. 40 Glycerin Propyl Gallate Propylene Glycol Water Sodium Benzoate Trisodium Citrate Dihydrate Sorbitol Sucralose Xanthan Gum

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2018-04-30

Description

Acetaminophen 650 mg Guaifenesin 400 mg Phenylephrine HCl 10 mg

Purpose

Pain reliever Expectorant Nasal decongestant

Medication Information

Purpose

Pain reliever Expectorant Nasal decongestant

Description

Acetaminophen 650 mg Guaifenesin 400 mg Phenylephrine HCl 10 mg

Uses

temporarily relieves
- headache
- nasal congestion
- minor aches and pains
- sinus congestion and pressure
- temporarily 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

Purposes

Pain reliever

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 daily while using this product

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

skin reddening
blisters
rash

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

Directions

do not take more than directed (see Overdose warning)
do not take more than 6 doses in any 24-hour period
measure only with dosing cup provided. Do not use any other dosing device.
keep dosing cup with product
mL=milliliter
dose as follows or as directed by a doctor
adults and children 12 years and older: 20 mL every 4 hours
children under 12 years of age: 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.
for children under 12 years of age
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.

Package Label

EQUATE Severe Congestion & Sinus Relief

Other Information

each 20 mL contains: sodium 12 mg
store between 20-25ºC (68-77ºF). Do not refrigerate.

Inactive Ingredients

anhydrous citric acid, EDTA disodium, FD&C blue #1, FD&C red #40, flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate, xanthan gum

Questions Or Comments?

Call 1-888-287-1915

Principal Display Panel

Compare to Maximum Strength Mucinex® Sinus-Max® Severe Congestion Relief active ingredients*

Severe Congestion & Sinus Relief

Acetaminophen - Pain Reliever

Guaifenesin - Expectorant

Phenylephrine HCI - Nasal Decongestant

MAXIMUM STRENGTH

Multi-Symptom Relief

Clear sinus congestion
Relieves headache
Thins & loosens mucus

For Ages 12+

FL OZ (mL)

*This product is not manufactured or distributed by Reckitt Benckiser, distributor of Maximum Strength Mucinex® Sinus-Max® Severe Congestion Relief.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND OR UNDER CAP IS BROKEN OR MISSING.

DISTRIBUTED BY: Walmart Inc.,

Bentonville, AR 72716

When Using This Product,

do not use more than directed.

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 last 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.

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick 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

Guaifenesin 400 mg

Phenylephrine HCl 10 mg

Ask A Doctor Before Use If You Have

liver disease
heart disease
diabetes
thyroid disease
high blood pressure
trouble urinating due to an enlarged prostate gland
persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
cough that occur 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
- headache
- nasal congestion
- minor aches and pains
- sinus congestion and pressure
- temporarily 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

Purposes

Pain reliever

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 daily while using this product

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

skin reddening
blisters
rash

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

Directions

do not take more than directed (see Overdose warning)
do not take more than 6 doses in any 24-hour period
measure only with dosing cup provided. Do not use any other dosing device.
keep dosing cup with product
mL=milliliter
dose as follows or as directed by a doctor
adults and children 12 years and older: 20 mL every 4 hours
children under 12 years of age: 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.
for children under 12 years of age
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.

Package Label

EQUATE Severe Congestion & Sinus Relief

Other Information (Other information)

each 20 mL contains: sodium 12 mg
store between 20-25ºC (68-77ºF). Do not refrigerate.

Inactive Ingredients (Inactive ingredients)

Questions Or Comments? (Questions or comments?)

Call 1-888-287-1915

Principal Display Panel

Compare to Maximum Strength Mucinex® Sinus-Max® Severe Congestion Relief active ingredients*

Severe Congestion & Sinus Relief

Acetaminophen - Pain Reliever

Guaifenesin - Expectorant

Phenylephrine HCI - Nasal Decongestant

MAXIMUM STRENGTH

Multi-Symptom Relief

Clear sinus congestion
Relieves headache
Thins & loosens mucus

For Ages 12+

FL OZ (mL)

*This product is not manufactured or distributed by Reckitt Benckiser, distributor of Maximum Strength Mucinex® Sinus-Max® Severe Congestion Relief.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND OR UNDER CAP IS BROKEN OR MISSING.

DISTRIBUTED BY: Walmart Inc.,

Bentonville, AR 72716

When Using This Product, (When using this product,)

do not use more than directed.

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 last 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 20 Ml) (Active ingredients (in each 20 mL))

Acetaminophen 650 mg

Guaifenesin 400 mg

Phenylephrine HCl 10 mg

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

liver disease
heart disease
diabetes
thyroid disease
high blood pressure
trouble urinating due to an enlarged prostate gland
persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
cough that occur 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

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Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves headache nasal congestion minor aches and pains sinus congestion and pressure temporarily 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 ", "Purposes": "Pain reliever 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 daily while using this product Allergy alert : Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away.", "Directions": "do not take more than directed (see Overdose warning) do not take more than 6 doses in any 24-hour period measure only with dosing cup provided. Do not use any other dosing device. keep dosing cup with product mL=milliliter dose as follows or as directed by a doctor adults and children 12 years and older: 20 mL every 4 hours children under 12 years of age: 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. for children under 12 years of age 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.", "Package Label": "EQUATE Severe Congestion & Sinus Relief", "Other information": "each 20 mL contains : sodium 12 mg store between 20-25ºC (68-77ºF). Do not refrigerate.", "Inactive ingredients": "anhydrous citric acid, EDTA disodium, FD&C blue #1, FD&C red #40, flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate, xanthan gum", "Questions or comments?": " Call 1-888-287-1915", "Principal Display Panel": "Compare to Maximum Strength Mucinex® Sinus-Max® Severe Congestion Relief active ingredients* Severe Congestion & Sinus Relief Acetaminophen - Pain Reliever Guaifenesin - Expectorant Phenylephrine HCI - Nasal Decongestant MAXIMUM STRENGTH Multi-Symptom Relief Clear sinus congestion Relieves headache Thins & loosens mucus For Ages 12+ FL OZ (mL) *This product is not manufactured or distributed by Reckitt Benckiser, distributor of Maximum Strength Mucinex® Sinus-Max® Severe Congestion Relief. TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND OR UNDER CAP IS BROKEN OR MISSING. DISTRIBUTED BY: Walmart Inc., Bentonville, AR 72716", "When using this product,": "do not use more than directed.", "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 last 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.": "Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick 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 Guaifenesin 400 mg Phenylephrine HCl 10 mg", "Ask a doctor before use if you have": "liver disease heart disease diabetes thyroid disease high blood pressure trouble urinating due to an enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough that occur with too much phlegm (mucus)", "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: 2026-02-15T12:02:53.969522 · Updated: 2026-03-14T23:02:42.365017