Cvs Pharmacy, Inc. Nighttime Cough Drug Facts

Cvs Pharmacy, Inc. Nighttime Cough Drug Facts
SPL v2
SPL
SPL Set ID 45471fdd-c4cd-46ad-a932-aa37327e8a41
Route
ORAL
Published
Effective Date 2024-10-16
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 Benzoic Acid Benzyl Alcohol Carboxymethylcellulose Sodium, Unspecified Fd&c Blue No. 1 Fd&c Red No. 40 Glycerin Menthol, Unspecified Form Polyethylene Glycol, Unspecified Propylene Glycol Water Sodium Benzoate Sorbitol Solution Sucralose Xanthan Gum

Identifiers & Packaging

Pill Appearance
Color: red
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-06-12

Description

Dextromethorphan HBr, USP 30 mg Doxylamine succinate, USP 12.5 mg

Purpose

Cough suppressant Antihistamine


Medication Information

Purpose

Cough suppressant Antihistamine

Description

Dextromethorphan HBr, USP 30 mg Doxylamine succinate, USP 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:
  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat
  • controls the impulse to cough to help you sleep
Purposes

Cough suppressant

Antihistamine

Directions
  • measure only with dosing cup provided
  • keep dosing cup with product
  • mL = milliliter
  • do not take more than 4 doses in any 24-hour period
  • this adult product is not intended for use in children under 12 years of age

age

dose

adults and children 12 years and over

20 mL every 6 hours

children under 12 years

do not use

Do Not Use
  • to make a child sleepy
  • 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 11 mg
  • store at 20-25°C (68-77°F)
Inactive Ingredients

anhydrous citric acid, benzoic acid, benzyl alcohol, carboxymethylcellulose sodium, FD&C blue #1, FD&C red #40, flavor, glycerin, menthol, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum

Questions Or Comments?

1-800-719-9260

When Using This Product
  • do not use more than directed
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children
Stop Use and Ask A Doctor If

cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.

If Pregnant Or Breast Feeding,

ask a health professional before use.

Active Ingredients (in Each 20 Ml)

Dextromethorphan HBr, USP 30 mg

Doxylamine succinate, USP 12.5 mg

Ask A Doctor Before Use If You Have
  • trouble urinating due to an enlarged prostate gland
  • glaucoma
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem such as emphysema or chronic bronchitis
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
Package/label Principal Display Panel

CVSHealth®

ADULT

MAXIMUM STRENGTH

NIGHTTIME COUGH

DEXTROMETHORPHAN HBr

Cough Suppressant

DOXYLAMINE SUCCINATE

Antihistamine

MULTI-SYMPTOM RELIEF

Controls cough

Relieves runny nose & sneezing

See New Dosing

Compare to the active ingredients in Robitussin® Maximum Strength Nighttime Cough DM

4 FL OZ (118 mL)

Raspberry, Blackberry & Menthol Flavor

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:
  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat
  • controls the impulse to cough to help you sleep
Purposes

Cough suppressant

Antihistamine

Directions
  • measure only with dosing cup provided
  • keep dosing cup with product
  • mL = milliliter
  • do not take more than 4 doses in any 24-hour period
  • this adult product is not intended for use in children under 12 years of age

age

dose

adults and children 12 years and over

20 mL every 6 hours

children under 12 years

do not use

Do Not Use (Do not use)
  • to make a child sleepy
  • 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 11 mg
  • store at 20-25°C (68-77°F)
Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, benzoic acid, benzyl alcohol, carboxymethylcellulose sodium, FD&C blue #1, FD&C red #40, flavor, glycerin, menthol, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum

Questions Or Comments? (Questions or comments?)

1-800-719-9260

When Using This Product (When using this product)
  • do not use more than directed
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful 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 lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Active Ingredients (in Each 20 Ml) (Active ingredients (in each 20 mL))

Dextromethorphan HBr, USP 30 mg

Doxylamine succinate, USP 12.5 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • trouble urinating due to an enlarged prostate gland
  • glaucoma
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem such as emphysema or chronic bronchitis
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
Package/label Principal Display Panel (Package/Label Principal Display Panel)

CVSHealth®

ADULT

MAXIMUM STRENGTH

NIGHTTIME COUGH

DEXTROMETHORPHAN HBr

Cough Suppressant

DOXYLAMINE SUCCINATE

Antihistamine

MULTI-SYMPTOM RELIEF

Controls cough

Relieves runny nose & sneezing

See New Dosing

Compare to the active ingredients in Robitussin® Maximum Strength Nighttime Cough DM

4 FL OZ (118 mL)

Raspberry, Blackberry & Menthol Flavor

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

All Sections (JSON)