Package Label

Package Label
SPL v6
SPL
SPL Set ID 552c942a-ae19-4e48-8bb7-198cd4e24a12
Route
ORAL
Published
Effective Date 2026-01-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Identifiers & Packaging


Description

Dextromethorphan HBr 20 mg Guaifenesin 400 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 cough the impulse to cough to help you get to sleep

Dosage and Administration

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 of age and older: 20 mL every 4 hours children under 12 years of age : do not use

Description

Dextromethorphan HBr 20 mg Guaifenesin 400 mg

Section 42229-5

each 20 mL contains : sodium 20 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

cough lasts more than 7 days, comes back, or occurs with fever, rash or persistent headache. These could be signs of a serious condition.

Section 50567-7

do not use more than directed

Section 50569-3

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

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

citric acid, disodium EDTA, FD & C red 40, flavors, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum

Section 51945-4

Compare to the active ingredients in Maximum Strength Mucinex® Fast-Max® DM Max* MAXIMUM STRENGTH MUCUS RELIEF DM MAX MULTI-SYMPTOM RELIEF COUGH SUPPRESSANT EXPECTORANT DEXTROMETHORPHAN HBr 20 mg GUAIFENESIN 400 mg Controls cough Relieves chest congestion Thins & loosen mucus For ages 12 & over 4-hour dosing For ages 12 and over FL OZ(mL) TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND OR UNDER CAP IS BROKEN OR MISSING. *This product is not manufactured or distributed by Reckitt Benckiser, distributor of Maximum Strength Mucinex® Fast-Max® DM Max. 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

Section 55106-9

Dextromethorphan HBr 20 mg Guaifenesin 400 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 cough the impulse to cough to help you get to sleep

Dosage and Administration (34068-7)

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 of age and older: 20 mL every 4 hours children under 12 years of age : do not use

Section 42229-5 (42229-5)

each 20 mL contains : sodium 20 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)

cough lasts more than 7 days, comes back, or occurs with fever, rash or persistent headache. These could be signs of a serious condition.

Section 50567-7 (50567-7)

do not use more than directed

Section 50569-3 (50569-3)

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)

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)

citric acid, disodium EDTA, FD & C red 40, flavors, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum

Section 51945-4 (51945-4)

Compare to the active ingredients in Maximum Strength Mucinex® Fast-Max® DM Max* MAXIMUM STRENGTH MUCUS RELIEF DM MAX MULTI-SYMPTOM RELIEF COUGH SUPPRESSANT EXPECTORANT DEXTROMETHORPHAN HBr 20 mg GUAIFENESIN 400 mg Controls cough Relieves chest congestion Thins & loosen mucus For ages 12 & over 4-hour dosing For ages 12 and over FL OZ(mL) TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND OR UNDER CAP IS BROKEN OR MISSING. *This product is not manufactured or distributed by Reckitt Benckiser, distributor of Maximum Strength Mucinex® Fast-Max® DM Max. 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

Section 55106-9 (55106-9)

Dextromethorphan HBr 20 mg Guaifenesin 400 mg


Raw Label Data

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