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

Active Ingredient

Dextromethorphan HBr 20 mg Guaifenesin 200 mg

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


Structured Label Content

Active Ingredient (55106-9)

Dextromethorphan HBr 20 mg Guaifenesin 200 mg

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


Raw Label Data

All Sections (JSON)