Nighttime Cough Solution
FDA Label NDC 51316-062

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cvs Woonsocket Prescription Center, Incorporated for the product Nighttime Cough (NDC 51316-062). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients (in each 20 ml), purposes, uses, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients (In Each 20 Ml)

Dextromethorphan HBr, USP 30 mg

Doxylamine succinate, USP 12.5 mg

Purposes

Cough suppressant

Antihistamine

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

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.

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

Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers

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.

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

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

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

Nighttime Cough Carton (Af73717c1 6w6)

Nighttime Cough Carton (Af73717c1 6w6)

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