Package Label

Package Label
SPL v3
SPL
SPL Set ID b3fc7747-9994-4848-8d2a-721a489efffb
Route
ORAL
Published
Effective Date 2024-11-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Identifiers & Packaging


Description

Dextromethorphan HBr 20 mg Guaifenesin 200 mg


Medication Information

Indications and Usage

temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

Dosage and Administration

do not take more than 6 doses in any 24-hour period measure only with the dosing cup provided. Do not use any other dosing device. keep dosing cup with product mL= milliliter this adult product is not intended for use in children under 12 years of age adults and children 12 years and over: 10 mL every 4 hours children under 12 years: do not use

Description

Dextromethorphan HBr 20 mg Guaifenesin 200 mg

Section 42229-5

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

Section 44425-7

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 is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

Section 50569-3

cough that occurs with too much phlegm (mucus) cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema

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

acesulfame potassium, anhydrous citric acid, flavor, glycerin, methylparaben, polyethylene glycol, povidone propylene glycol, purified water, saccharin sodium, sodium benzoate

Section 51945-4

Compare to the active ingredients in Robitussin® Peak Cold Sugar-Free Cough-+Chest Congestion DM* FREE   ALCOHOL FREE FROM  SUGAR FREE TUSSIN COUGH + CHEST CONGESTION ADULT NON-DROWSY • ALCOHOL FREE COUGH SUPPRESSANT EXPECTORANT DEXTROMETHORPHAN HBr 20 mg GUAIFENESIN 200 mg Relieves cough, mucus Specially formulated for diabetics For ages 12 years and over DM SUGAR-FREE FL OZ (mL) DOSAGE CUP INCLUDED *This product is not manufactured or distributed by Pfizer Consumer Healthcare, distributors of Robitussin® Peak Cold Sugar-Free Cough + Chest Congestion DM. TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING . DISTRIBUTED BY: RITE AID 30 HUNTER LANE, CAMP HILL, PA 17011 www.riteaid.com

Section 53414-9

ask a health professional before use.

Section 55105-1

Cough suppressant Expectorant

Section 55106-9

Dextromethorphan HBr 20 mg Guaifenesin 200 mg


Structured Label Content

Indications and Usage (34067-9)

temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

Dosage and Administration (34068-7)

do not take more than 6 doses in any 24-hour period measure only with the dosing cup provided. Do not use any other dosing device. keep dosing cup with product mL= milliliter this adult product is not intended for use in children under 12 years of age adults and children 12 years and over: 10 mL every 4 hours children under 12 years: do not use

Section 42229-5 (42229-5)

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

Section 44425-7 (44425-7)

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 is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

Section 50569-3 (50569-3)

cough that occurs with too much phlegm (mucus) cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema

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)

acesulfame potassium, anhydrous citric acid, flavor, glycerin, methylparaben, polyethylene glycol, povidone propylene glycol, purified water, saccharin sodium, sodium benzoate

Section 51945-4 (51945-4)

Compare to the active ingredients in Robitussin® Peak Cold Sugar-Free Cough-+Chest Congestion DM* FREE   ALCOHOL FREE FROM  SUGAR FREE TUSSIN COUGH + CHEST CONGESTION ADULT NON-DROWSY • ALCOHOL FREE COUGH SUPPRESSANT EXPECTORANT DEXTROMETHORPHAN HBr 20 mg GUAIFENESIN 200 mg Relieves cough, mucus Specially formulated for diabetics For ages 12 years and over DM SUGAR-FREE FL OZ (mL) DOSAGE CUP INCLUDED *This product is not manufactured or distributed by Pfizer Consumer Healthcare, distributors of Robitussin® Peak Cold Sugar-Free Cough + Chest Congestion DM. TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING . DISTRIBUTED BY: RITE AID 30 HUNTER LANE, CAMP HILL, PA 17011 www.riteaid.com

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 200 mg


Raw Label Data

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