Package Label

Package Label
SPL v6
SPL
SPL Set ID e85bbc70-c7f8-455d-8c0f-0c3c4ce8d5ac
Route
ORAL
Published
Effective Date 2025-12-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Identifiers & Packaging


Description

Dextromethorphan HBr 20 mg Guaifenesin 400 mg Phenylephrine HCL 10 mg


Medication Information

Indications and Usage

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive   temporarily relieves: cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants the intensity of coughing the impulse to cough to help you get to sleep nasal congestion due to a cold

Dosage and Administration

do not take more than 6 doses in a 24-hour period measure only with dosing cup provided Do not use any other dosing device. keep dosing cup with product mL=milliliter shake well before using adults and children 12 years of age and older: 20 mL in dosing cup provided every 4 hours children under 12 years of age: do not use

Description

Dextromethorphan HBr 20 mg Guaifenesin 400 mg Phenylephrine HCL 10 mg

Section 42229-5

each 20 mL contains : sodium 17 mg store between 20-25ºC (68-77ºF). Do not refrigerate.

Section 50565-1

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 50566-9

nervousness, dizziness or sleeplessness occur symptoms do not get better within 7 days or occur with a fever cough comes back, or occurs with fever, rash or headache that lasts These could be signs of a serious condition.

Section 50567-7

do not use more than directed.

Section 50569-3

heart disease thyroid disease diabetes 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 occurs with too much phlegm (mucus)

Section 50570-1

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.

Section 51727-6

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

Section 51945-4

Compare to the active ingredients in Maximum Strength Mucinex® Fast-Max® Severe Congestion & Cough* MAXIMUM STRENGTH MUCUS RELIEF SEVERE COUGH & CONGESTION MULTI-SYMPTOM RELIEF COUGH SUPPRESSANT EXPECTORANT NASAL DECONGESTANT DEXTROMETHORPHAN HBr 20 mg GUAIFENESIN 400 mg PHENYLEPHRINE HCL 10 MG Temporarily controls cough Relieves nasal & chest congestion Thins & loosens mucus For ages 12 & over FL OZ (mL) *This product is not manufactured or distributed by Reckitt Benckiser, distributor of Maximum Strength Mucinex® Fast-Max® Severe Congestion & Cough. TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND OR UNDER CAP IS BROKEN OR MISSING. DISTRIBUTED BY: RITE AID, 30 HUNTER LANE CAMP HILL, PA 17011 www.riteaid.com

Section 53413-1

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Section 53414-9

ask a health professional before use.

Section 55105-1

Cough suppressant Expectorant Nasal Decongestant

Section 55106-9

Dextromethorphan HBr 20 mg Guaifenesin 400 mg Phenylephrine HCL 10 mg


Structured Label Content

Indications and Usage (34067-9)

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive   temporarily relieves: cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants the intensity of coughing the impulse to cough to help you get to sleep nasal congestion due to a cold

Dosage and Administration (34068-7)

do not take more than 6 doses in a 24-hour period measure only with dosing cup provided Do not use any other dosing device. keep dosing cup with product mL=milliliter shake well before using adults and children 12 years of age and older: 20 mL in dosing cup provided every 4 hours children under 12 years of age: do not use

Section 42229-5 (42229-5)

each 20 mL contains : sodium 17 mg store between 20-25ºC (68-77ºF). Do not refrigerate.

Section 50565-1 (50565-1)

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 50566-9 (50566-9)

nervousness, dizziness or sleeplessness occur symptoms do not get better within 7 days or occur with a fever cough comes back, or occurs with fever, rash or headache that lasts These could be signs of a serious condition.

Section 50567-7 (50567-7)

do not use more than directed.

Section 50569-3 (50569-3)

heart disease thyroid disease diabetes 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 occurs with too much phlegm (mucus)

Section 50570-1 (50570-1)

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.

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

Compare to the active ingredients in Maximum Strength Mucinex® Fast-Max® Severe Congestion & Cough* MAXIMUM STRENGTH MUCUS RELIEF SEVERE COUGH & CONGESTION MULTI-SYMPTOM RELIEF COUGH SUPPRESSANT EXPECTORANT NASAL DECONGESTANT DEXTROMETHORPHAN HBr 20 mg GUAIFENESIN 400 mg PHENYLEPHRINE HCL 10 MG Temporarily controls cough Relieves nasal & chest congestion Thins & loosens mucus For ages 12 & over FL OZ (mL) *This product is not manufactured or distributed by Reckitt Benckiser, distributor of Maximum Strength Mucinex® Fast-Max® Severe Congestion & Cough. TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND OR UNDER CAP IS BROKEN OR MISSING. DISTRIBUTED BY: RITE AID, 30 HUNTER LANE CAMP HILL, PA 17011 www.riteaid.com

Section 53413-1 (53413-1)

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Section 53414-9 (53414-9)

ask a health professional before use.

Section 55105-1 (55105-1)

Cough suppressant Expectorant Nasal Decongestant

Section 55106-9 (55106-9)

Dextromethorphan HBr 20 mg Guaifenesin 400 mg Phenylephrine HCL 10 mg


Raw Label Data

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