Drug Facts

Drug Facts

SPL v1

SPL

SPL Set ID e1fa0f51-6a68-4f6f-8988-0949d1942c2f

Route

ORAL

Published

Effective Date 2024-04-18

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Dextromethorphan (30 mg) Doxylamine (12.5 mg)

Inactive Ingredients

Alcohol Anhydrous Citric Acid Fd&c Blue No. 1 Fd&c Red No. 40 High Fructose Corn Syrup Polyethylene Glycol, Unspecified Propylene Glycol Water Saccharin Sodium Trisodium Citrate Dihydrate

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2024-07-31

Description

Dextromethorphan HBr 30 mg Doxylamine succinate 12.5 mg

Purpose

Cough suppressant Antihistamine

Medication Information

Purpose

Cough suppressant

Antihistamine

Description

Dextromethorphan HBr 30 mg Doxylamine succinate 12.5 mg

Uses

temporarily relieves cold symptoms
- cough due to minor throat and bronchial irritation
- runny nose and sneezing

Directions

do not take more than 4 doses in any 24-hour period
measure only with dosing cup provided. Do not use any other dosing device
keep dosing cup with product
take only as directed
mL = milliliter
adults and children 12 years and over: 30 mL every 6 hours
children under 12 years of age: do not use

Do Not Use

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.

Product Label

QUALITY CHOICE Nighttime Cough Relief Cherry Flavor

Other Information

each 30 mL contains; sodium 29 mg
store between 20-25ºC (68-77º). Do not refrigerate.

Inactive Ingredients

alcohol, citric acid, FD&C blue 1, FD&C red 40, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate

Questions Or Comments?

Call

Principal Display Panel

Nighttime Cough Relief

Dextromethorphan HBr 30 mg

Cough suppressant

Doxylamine succinate 12.5 mg

Antihistamine

relieves

Cough
Runny nose
Sneezing

For ages12 years and over

Nighttime relief

Alcohol 10%

CHERRY FLAVOR

FL OZ (mL)

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

Distributed by:

When Using This Product

excitability may occur, especially in children
marked drowsiness may occur
avoid alcoholic drinks
alcohol, sedatives, and tranquilizers may increase drowsiness
be careful when driving a motor vehicle or operating machinery

Stop Use and Ask A Doctor If

Cough lasts more than 7 days,come back, or is accompanied by fever, rash, or persistent headache. 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.

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

Active Ingredients (in Each 30 Ml)

Dextromethorphan HBr 30 mg

Doxylamine succinate 12.5 mg

Ask A Doctor Before Use If You Have

glaucoma
cough that occurs with too much phlegm(mucus)
a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis,or emphysema
trouble urinating due to enlarged prostate gland

Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers.

Structured Label Content

Uses

temporarily relieves cold symptoms
- cough due to minor throat and bronchial irritation
- runny nose and sneezing

Purpose

Cough suppressant

Antihistamine

Directions

do not take more than 4 doses in any 24-hour period
measure only with dosing cup provided. Do not use any other dosing device
keep dosing cup with product
take only as directed
mL = milliliter
adults and children 12 years and over: 30 mL every 6 hours
children under 12 years of age: do not use

Do Not Use (Do not use)

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.

Product Label

QUALITY CHOICE Nighttime Cough Relief Cherry Flavor

Other Information (Other information)

each 30 mL contains; sodium 29 mg
store between 20-25ºC (68-77º). Do not refrigerate.

Inactive Ingredients (Inactive ingredients)

alcohol, citric acid, FD&C blue 1, FD&C red 40, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate

Questions Or Comments? (Questions or comments?)

Call

Principal Display Panel

Nighttime Cough Relief

Dextromethorphan HBr 30 mg

Cough suppressant

Doxylamine succinate 12.5 mg

Antihistamine

relieves

Cough
Runny nose
Sneezing

For ages12 years and over

Nighttime relief

Alcohol 10%

CHERRY FLAVOR

FL OZ (mL)

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

Distributed by:

When Using This Product (When using this product)

excitability may occur, especially in children
marked drowsiness may occur
avoid alcoholic drinks
alcohol, sedatives, and tranquilizers may increase drowsiness
be careful when driving a motor vehicle or operating machinery

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

Cough lasts more than 7 days,come back, or is accompanied by fever, rash, or persistent headache. 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.)

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

Active Ingredients (in Each 30 Ml) (Active ingredients (in each 30 mL))

Dextromethorphan HBr 30 mg

Doxylamine succinate 12.5 mg

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

glaucoma
cough that occurs with too much phlegm(mucus)
a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis,or emphysema
trouble urinating due to enlarged prostate gland

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking sedatives or tranquilizers.

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves cold symptoms cough due to minor throat and bronchial irritation runny nose and sneezing", "Purpose": "Cough suppressant Antihistamine", "Directions": "do not take more than 4 doses in any 24-hour period measure only with dosing cup provided. Do not use any other dosing device keep dosing cup with product take only as directed mL = milliliter adults and children 12 years and over: 30 mL every 6 hours children under 12 years of age: do not use", "Do not use": "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.", "Product Label": "QUALITY CHOICE Nighttime Cough Relief Cherry Flavor", "Other information": "each 30 mL contains ; sodium 29 mg store between 20-25ºC (68-77º). Do not refrigerate.", "Inactive ingredients": "alcohol, citric acid, FD&C blue 1, FD&C red 40, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate", "Questions or comments?": " Call", "Principal Display Panel": "Nighttime Cough Relief Dextromethorphan HBr 30 mg Cough suppressant Doxylamine succinate 12.5 mg Antihistamine relieves Cough Runny nose Sneezing For ages12 years and over Nighttime relief Alcohol 10% CHERRY FLAVOR FL OZ (mL) TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND DOSAGE CUP OR UNDER CAP IS BROKEN OR MISSING. Distributed by:", "When using this product": "excitability may occur, especially in children marked drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery", "Stop use and ask a doctor if": "Cough lasts more than 7 days,come back, or is accompanied by fever, rash, or persistent headache. 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.": "In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.", "Active ingredients (in each 30 mL)": "Dextromethorphan HBr 30 mg Doxylamine succinate 12.5 mg", "Ask a doctor before use if you have": "glaucoma cough that occurs with too much phlegm(mucus) a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis,or emphysema trouble urinating due to enlarged prostate gland", "Ask a doctor or pharmacist before use if you are": "taking sedatives or tranquilizers."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:21.370675 · Updated: 2026-03-14T23:03:22.878855