Quality Plus 44-043

Quality Plus 44-043
SPL v7
SPL
SPL Set ID 75a9c736-bc7e-4b7f-84ea-9474a37508ec
Route
ORAL
Published
Effective Date 2025-06-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (30 mg) Doxylamine (12.5 mg)
Inactive Ingredients
Anhydrous Citric Acid Fd&c Blue No. 1 Fd&c Red No. 40 Glycerin High Fructose Corn Syrup Polyethylene Glycol, Unspecified Propylene Glycol Water Sodium Benzoate Sodium Chloride Trisodium Citrate Dihydrate Sucralose Sucrose Xanthan Gum

Identifiers & Packaging

Pill Appearance
Color: red
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-07-16

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 cough due to minor throat and bronchial irritation as may occur with a cold

  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

    • itching of the nose or throat 
    • sneezing

    • itchy, watery eyes
    • runny nose

  • controls the impulse to cough to help you sleep

Directions
  • do not take more than directed
  • do not take more than 4 doses in any 24-hour period

  • mL = milliliter

  • only use the dose cup provided
  • adults and children 12 years and over: 20 mL in dosing cup provided every 6 hours

  • children under 12 years: 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.

Other Information
  • each 20 mL contains: sodium 14 mg

  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

  • see end flap for expiration date and lot number

Inactive Ingredients

anhydrous citric acid, FD&C blue #1, FD&C red #40, flavors, glycerin, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sucralose, sugar, xanthan gum

Questions Or Comments?

1-800-426-9391

Principal Display Panel

NDC 50844-043-36

Quality 

+Plus 

Compare to the active ingredients

in Robitussin® MAXIMUM STRENGTH

Nighttime Cough DM*

MAXIMUM STRENGTH

NIGHTTIME

COUGH DM

DEXTROMETHORPHAN HBr

Cough suppressant

DOXYLAMINE SUCCINATE

Antihistamine

• Controls cough

• Relieves runny

nose & sneezing

Menthol-Berry

Flavor

Ages 12 Years and Over

Dosage cup

included

4 FL OZ (118 mL)

TAMPER EVIDENT: DO NOT USE IF PRINTED

NECK WRAP IS BROKEN OR MISSING

TAMPER EVIDENT: DO NOT USE IF IMPRINTED

SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

*This product is not manufactured or distributed by

GlaxoSmithKline Consumer Healthcare Holdings (US) LLC,

owner of the registered trademark Robitussin® MAXIMUM

STRENGTH Nighttime Cough DM.

50844        REV0123A04336

Distributed by

LNK INTERNATIONAL, INC.

60 Arkay Drive

Hauppauge, NY 11788

USA

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

Quality Plus 44-043

When Using This Product
  • marked drowsiness may occur

  • alcohol, sedatives, and tranquilizers may increase drowsiness

  • avoid alcoholic drinks

  • use caution when driving a motor vehicle or operating machinery

  • excitability may occur, especially in children

Stop Use and Ask A Doctor If

cough persists more than 7 days, tends to recur, or is accompanied by a 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 right away.

Active Ingredients (in Each 20 Ml)

Dextromethorphan HBr 30 mg

Doxylamine succinate 12.5 mg

Ask A Doctor Before Use If You Have
  • a cough that occurs with too much phlegm (mucus)
  • glaucoma

  • difficulty in urination due to enlargement of the prostate gland

  • a breathing problem or persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema

Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers.


Structured Label Content

Uses
  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold

  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

    • itching of the nose or throat 
    • sneezing

    • itchy, watery eyes
    • runny nose

  • controls the impulse to cough to help you sleep

Purpose

Cough suppressant

Antihistamine

Directions
  • do not take more than directed
  • do not take more than 4 doses in any 24-hour period

  • mL = milliliter

  • only use the dose cup provided
  • adults and children 12 years and over: 20 mL in dosing cup provided every 6 hours

  • children under 12 years: 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.

Other Information (Other information)
  • each 20 mL contains: sodium 14 mg

  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

  • see end flap for expiration date and lot number

Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, FD&C blue #1, FD&C red #40, flavors, glycerin, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sucralose, sugar, xanthan gum

Questions Or Comments? (Questions or comments?)

1-800-426-9391

Principal Display Panel (Principal display panel)

NDC 50844-043-36

Quality 

+Plus 

Compare to the active ingredients

in Robitussin® MAXIMUM STRENGTH

Nighttime Cough DM*

MAXIMUM STRENGTH

NIGHTTIME

COUGH DM

DEXTROMETHORPHAN HBr

Cough suppressant

DOXYLAMINE SUCCINATE

Antihistamine

• Controls cough

• Relieves runny

nose & sneezing

Menthol-Berry

Flavor

Ages 12 Years and Over

Dosage cup

included

4 FL OZ (118 mL)

TAMPER EVIDENT: DO NOT USE IF PRINTED

NECK WRAP IS BROKEN OR MISSING

TAMPER EVIDENT: DO NOT USE IF IMPRINTED

SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

*This product is not manufactured or distributed by

GlaxoSmithKline Consumer Healthcare Holdings (US) LLC,

owner of the registered trademark Robitussin® MAXIMUM

STRENGTH Nighttime Cough DM.

50844        REV0123A04336

Distributed by

LNK INTERNATIONAL, INC.

60 Arkay Drive

Hauppauge, NY 11788

USA

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

Quality Plus 44-043

When Using This Product (When using this product)
  • marked drowsiness may occur

  • alcohol, sedatives, and tranquilizers may increase drowsiness

  • avoid alcoholic drinks

  • use caution when driving a motor vehicle or operating machinery

  • excitability may occur, especially in children

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

cough persists more than 7 days, tends to recur, or is accompanied by a 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 right away.

Active Ingredients (in Each 20 Ml) (Active ingredients (in each 20 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)
  • a cough that occurs with too much phlegm (mucus)
  • glaucoma

  • difficulty in urination due to enlargement of the prostate gland

  • a breathing problem or persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema

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


Raw Label Data

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