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Up and up nighttime cough control dm max - Medication Information

Product NDC Code 11673-719
Drug Name

Up and up nighttime cough control dm max

Type Brand
Pharm Class Antihistamine [EPC],
Histamine Receptor Antagonists [MoA],
Sigma-1 Agonist [EPC],
Sigma-1 Receptor Agonists [MoA],
Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC],
Uncompetitive NMDA Receptor Antagonists [MoA]
Active Ingredients
Dextromethorphan hydrobromide 30 mg/20ml
Doxylamine succinate 12.5 mg/20ml
Route ORAL
Dosage Form SOLUTION
RxCUI drug identifier 1115329
Application Number part341
Labeler Name Target Corporation
Packages
Package NDC Code Description
11673-719-34 1 bottle in 1 carton (11673-719-34) / 237 ml in 1 bottle
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredients (in each 20 mL) Dextromethorphan HBr, USP 30 mg Doxylamine succinate, USP 12.5 mg

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
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
age dose
adults and children 12 years and over 20 mL every 6 hours
children under 12 years do not use

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
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

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
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

Purpose

Information about the drug product’s indications for use.
Purposes Cough suppressant Antihistamine

Spl product data elements

Usually a list of ingredients in a drug product.
up and up nighttime cough control dm max Dextromethorphan HBr, Doxylamine succinate DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN DOXYLAMINE SUCCINATE DOXYLAMINE ANHYDROUS CITRIC ACID BENZOIC ACID BENZYL ALCOHOL CARBOXYMETHYLCELLULOSE SODIUM FD&C BLUE NO. 1 FD&C RED NO. 40 GLYCERIN MENTHOL POLYETHYLENE GLYCOL PROPYLENE GLYCOL WATER SODIUM BENZOATE SORBITOL SUCRALOSE XANTHAN GUM

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
Package/Label Principal Display Panel see new dosing Compare to active ingredients in Robitussin® Maximum Strength Nighttime Cough DM maximum strength nighttime cough control DM MAX dextromethorphan HBr (cough suppressant) doxylamine succinate (antihistamine) relieves cough, itchy throat and runny nose for adults AGES 12 + YEARS 8 FL OZ (237 mL) nighttime-cough-control-dm-max-image

Ask doctor

Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.
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 doctor or pharmacist

Information about when a doctor or pharmacist should be consulted about drug/drug or drug/food interactions before using a drug product.
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

Do not use

Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.
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.

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
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).

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions or comments? 1-888-547-7400

Stop use

Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.
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.

When using

Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug 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

Pregnancy or breast feeding

Pregnancy or Breast feeding
If pregnant or breast-feeding, ask a health professional before use.

Storage and handling

Information about safe storage and handling of the drug product.
Other information • each 20 mL contains: sodium 11 mg • store at 20-25°C (68-77°F)

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
Warnings

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API