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

Purpose

Cough suppressant Antihistamine

Description

Dextromethorphan HBr 30 mg Doxylamine succinate 12.5 mg


Medication Information

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

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

Description

Dextromethorphan HBr 30 mg Doxylamine succinate 12.5 mg

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

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.

Questions Or Comments?

1-800-426-9391

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

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

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

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.

Questions Or Comments? (Questions or comments?)

1-800-426-9391

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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