Drug Facts

Drug Facts

SPL v4

SPL

SPL Set ID f658a03b-6fc2-4b63-b3ab-7e886fbf20b4

Route

ORAL

Published

Effective Date 2024-05-15

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 2018-01-31

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-hours 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

SIGNATURE CARE Nighttime Cough Relief

Other Information

each 30 mL contains; sodium 29 mg
store between 20-25ºC (68-77ºF). 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 1-888-723-3929 Monday-Friday 7AM-6PM PST

Principal Display Panel

Compare to Vicks® NyQuil® Cough active ingredients*

NightTime Cough Relief

DEXTROMETHORPHAN HBr 30 mg - Cough Suppressant

DOXYLAMINE SUCCINATE 12.5 mg - Antihistamine

CHERRY FLAVOR

Sneezing, runny nose, cough
For ages 12 years & over
Nighttime relief
Alcohol 10%

FL OZ (mL)

*This product is not manufactured or distributed by The Proctor & Gamble Company, Vicks® and NyQuil® are registered trademarks of The Procter & Gamble Company.

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

DISTREBUTED BY BETTER LIVING BRANDS LLC

P.O. BOX 99, PLEASANTON, CA 94566-0009

www.betterlivingbrandsLLC.com

When Using This Product

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

Stop Use and Ask A Doctor If

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

These could be sign 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-hours 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

SIGNATURE CARE Nighttime Cough Relief

Other Information (Other information)

each 30 mL contains; sodium 29 mg
store between 20-25ºC (68-77ºF). 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 1-888-723-3929 Monday-Friday 7AM-6PM PST

Principal Display Panel

Compare to Vicks® NyQuil® Cough active ingredients*

NightTime Cough Relief

DEXTROMETHORPHAN HBr 30 mg - Cough Suppressant

DOXYLAMINE SUCCINATE 12.5 mg - Antihistamine

CHERRY FLAVOR

Sneezing, runny nose, cough
For ages 12 years & over
Nighttime relief
Alcohol 10%

FL OZ (mL)

*This product is not manufactured or distributed by The Proctor & Gamble Company, Vicks® and NyQuil® are registered trademarks of The Procter & Gamble Company.

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

DISTREBUTED BY BETTER LIVING BRANDS LLC

P.O. BOX 99, PLEASANTON, CA 94566-0009

www.betterlivingbrandsLLC.com

When Using This Product (When using this product)

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

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

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

These could be sign 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-hours 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": "SIGNATURE CARE Nighttime Cough Relief", "Other information": "each 30 mL contains ; sodium 29 mg store between 20-25ºC (68-77ºF). 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 1-888-723-3929 Monday-Friday 7AM-6PM PST", "Principal Display Panel": "Compare to Vicks® NyQuil® Cough active ingredients* NightTime Cough Relief DEXTROMETHORPHAN HBr 30 mg - Cough Suppressant DOXYLAMINE SUCCINATE 12.5 mg - Antihistamine CHERRY FLAVOR Sneezing, runny nose, cough For ages 12 years & over Nighttime relief Alcohol 10% FL OZ (mL) *This product is not manufactured or distributed by The Proctor & Gamble Company, Vicks® and NyQuil® are registered trademarks of The Procter & Gamble Company. TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND DOSAGE CUP OR UNDER CAP IS BROKEN OR MISSING. DISTREBUTED BY BETTER LIVING BRANDS LLC P.O. BOX 99, PLEASANTON, CA 94566-0009 www.betterlivingbrandsLLC.com", "When using this product": "excitability may occur, especially in children marked drowsiness may occur avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery alcohol, sedatives, and tranquilizers may increase drowsiness", "Stop use and ask a doctor if": "cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be sign 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

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:03:06.150523 · Updated: 2026-03-14T23:02:57.214195