NDC 0031-8758 Robitussin Honey Maximum Strength Nighttime Cough Dm
Dextromethorphan Hbr, Doxylamine Succinate Solution Oral
Product Information
What is NDC 0031-8758?
The NDC code 0031-8758 is assigned by the FDA to the product Robitussin Honey Maximum Strength Nighttime Cough Dm which is a human over the counter drug product labeled by Glaxosmithkline Consumer Healthcare Holdings (us) Llc. The generic name of Robitussin Honey Maximum Strength Nighttime Cough Dm is dextromethorphan hbr, doxylamine succinate. The product's dosage form is solution and is administered via oral form. The product is distributed in 2 packages with assigned NDC codes 0031-8758-12 1 bottle in 1 carton / 118 ml in 1 bottle, 0031-8758-18 1 bottle in 1 carton / 237 ml in 1 bottle. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.
What are the uses for Robitussin Honey Maximum Strength Nighttime Cough Dm?
This product is used as Active ingredients (in each 20 ml)PurposesDextromethorphan HBr, USP 30 mgCough suppressantDoxylamine Succinate, USP 12.5 mgAntihistamine. Temporarily relieves cough due to minor throat and bronchial irritation as may occur with a coldtemporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nosesneezingitchy, watery eyesitching of the nose or throatcontrols the impulse to cough to help you sleep
Product Characteristics
Flavor(s) | BERRY (C73365) |
Product Packages
NDC Code 0031-8758-12
Package Description: 1 BOTTLE in 1 CARTON / 118 mL in 1 BOTTLE
NDC Code 0031-8758-18
Package Description: 1 BOTTLE in 1 CARTON / 237 mL in 1 BOTTLE
Product Details
What are Robitussin Honey Maximum Strength Nighttime Cough Dm Active Ingredients?
- DEXTROMETHORPHAN HYDROBROMIDE 30 mg/20mL - Methyl analog of DEXTRORPHAN that shows high affinity binding to several regions of the brain, including the medullary cough center. This compound is an NMDA receptor antagonist (RECEPTORS, N-METHYL-D-ASPARTATE) and acts as a non-competitive channel blocker. It is one of the widely used ANTITUSSIVES, and is also used to study the involvement of glutamate receptors in neurotoxicity.
- DOXYLAMINE SUCCINATE 12.5 mg/20mL
Robitussin Honey Maximum Strength Nighttime Cough Dm Active Ingredients UNII Codes
- DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH)
- DEXTROMETHORPHAN (UNII: 7355X3ROTS) (Active Moiety)
- DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2)
- DOXYLAMINE (UNII: 95QB77JKPL) (Active Moiety)
NDC to RxNorm Crosswalk
- RxCUI: 1115329 - dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 20 mL Oral Solution
- RxCUI: 1115329 - dextromethorphan hydrobromide 1.5 MG/ML / doxylamine succinate 0.625 MG/ML Oral Solution
- RxCUI: 1115329 - dextromethorphan hydrobromide 30 MG / doxylamine succinate 12.5 MG per 20 ML Oral Solution
- RxCUI: 1115329 - dextromethorphan hydrobromide 7.5 MG / doxylamine succinate 3.125 MG per 5 ML Oral Solution
Robitussin Honey Maximum Strength Nighttime Cough Dm Inactive Ingredients UNII Codes
- ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
- CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
- GLYCERIN (UNII: PDC6A3C0OX)
- LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)
- HONEY (UNII: Y9H1V576FH)
- POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
- PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
- WATER (UNII: 059QF0KO0R)
- SODIUM BENZOATE (UNII: OJ245FE5EU)
- SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
- SODIUM GLUCONATE (UNII: R6Q3791S76)
- SUCRALOSE (UNII: 96K6UQ3ZD4)
- XANTHAN GUM (UNII: TTV12P4NEE)
- ZINC GLUCONATE (UNII: U6WSN5SQ1Z)
Pharmacologic Class(es)
- Antihistamine - [EPC] (Established Pharmacologic Class)
- Histamine Receptor Antagonists - [MoA] (Mechanism of Action)
- Sigma-1 Agonist - [EPC] (Established Pharmacologic Class)
- Sigma-1 Receptor Agonists - [MoA] (Mechanism of Action)
- Uncompetitive N-methyl-D-aspartate Receptor Antagonist - [EPC] (Established Pharmacologic Class)
- Uncompetitive NMDA Receptor Antagonists - [MoA] (Mechanism of Action)
* Please review the disclaimer below.
Robitussin Honey Maximum Strength Nighttime Cough Dm Product Label
FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
Product Label Table of Contents
- OTHER
- OTC - PURPOSE
- USES
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- OTC - ASK DOCTOR/PHARMACIST
- WHEN USING THIS PRODUCT
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL - 118 ML BOTTLE LABEL
- PRINCIPAL DISPLAY PANEL - 118 ML BOTTLE CARTON
Other
Drug Facts
Distributed by: Pfizer, Madison, NJ 07940 USA
Otc - Purpose
Active ingredients (in each 20 ml) | Purposes |
---|---|
Dextromethorphan HBr, USP 30 mg | Cough suppressant |
Doxylamine Succinate, USP 12.5 mg | 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 sedate a child or 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
- a cough that occurs with too much phlegm (mucus)
- a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema
Otc - Ask Doctor/Pharmacist
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
Otc - Stop Use
Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - 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.
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 21 mg
- store at 20-25°C (68-77°F)
Inactive Ingredients
anhydrous citric acid, blueberry juice concentrate, carboxymethylcellulose sodium, glycerin, lactic acid, natural and artificial flavors, natural grade A honey, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium gluconate, sucralose, xanthan gum, zinc gluconate
Questions Or Comments?
call weekdays from 9 AM to 5 PM EST at 1-800-762-4675
Principal Display Panel - 118 Ml Bottle Label
ADULT
Robitussin®
Honey
MAXIMUM STRENGTH
Nighttime
Cough DM
DM
NIGHTTIME
MAX
DEXTROMETHORPHAN HBr (Cough Suppressant)
DOXYLAMINE SUCCINATE (Antihistamine)
4 FL OZ (118 ml)
Principal Display Panel - 118 Ml Bottle Carton
ADULT
NEW!
Robitussin®
Honey
Nighttime
Cough DM
DEXTROMETHORPHAN HBr (Cough Suppressant)
DOXYLAMINE SUCCINATE (Antihistamine)
MAXIMUM STRENGTH
✓ Controls Cough✓ Relieves runny nose and sneezing
Taste the
Real Honey
DM
NIGHTTIME
MAX
For Ages 12+
4 FL OZ (118 ml)
* Please review the disclaimer below.