tussin nighttime cough

DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE ORAL HUMAN OTC DRUG

tussin nighttime cough is an FDA drug label for the active ingredient DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE manufactured by Rite Aid Corporation administered by ORAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20260904.

Generic name
DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE
Manufacturer
Rite Aid Corporation
Product type
HUMAN OTC DRUG
Route
ORAL
Dosage form
N/A
NDC
11822-6005
Application
M012
Label effective
20260904

About this product

tussin nighttime cough is an FDA-registered drug product whose active ingredient is DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE. It is labelled by Rite Aid Corporation taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 11822-6005, application M012, label effective 20260904. It is one of 3 FDA drug label records sharing the active ingredient DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

What it is used for

Across FDA labelling, products containing DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE are most often described in connection with: temporarily relieves, cough due, minor throat, bronchial irritation, hay fever, upper respiratory, allergies runny, nose sneezing. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Active ingredients

Active ingredients (in each 20 mL) Dextromethorphan HBr, USP 30 mg Doxylamine succinate, USP 12.5 mg

Indications & Usage

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

Dosage & Administration

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

Warnings

Warnings 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. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

More products with the same ingredient

DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE

NIGHTTIME COUGH DM

CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED View label

nighttime cough dm

Meijer, Inc. View label

How products containing DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE compare

FDA lists 3 drug label records with DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

Dosage formProductsManufacturerProducts
— — CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED 1
— — Meijer, Inc. 1
— — Rite Aid Corporation 1
— — — —
— — — —

Frequently asked questions

What is tussin nighttime cough used for?
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

Who makes tussin nighttime cough?
Rite Aid Corporation is the labeler of record for tussin nighttime cough. 3 FDA label records share the active ingredient DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does tussin nighttime cough come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is tussin nighttime cough prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE?
Yes. 3 FDA drug label records list DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has tussin nighttime cough been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.

This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.