Robotablets Tablet
FDA Label NDC 71598-015

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dxm Pharmaceutical, Inc for the product Robotablets (NDC 71598-015). 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, purpose, uses, warnings, otc - keep out of reach of children, directions, inactive ingredients, image, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Dextromethorphan 30 mg

Purpose

Cough suppressant 

Uses

Temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold.

Warnings

Do not use 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

  • a cough that is accompanied by excessive phlegm (mucus), or
  • a persistent or chronic cough such as occurs with smoking, asthma, or emphysema.

    • Stop use and ask a doctor if a cough persists for more than 1 week, tends to recur, 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.

Otc - Keep Out Of Reach Of Children

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

Directions

  • only use this product according to these directions or as directed by a doctor
  • do not exceed 4 tablets in any 24-hour period
  • this adult product is not intended for use in children under 12 years of age
    • AgeDose
     adults and children 12 years and over take 1 tablet every 6 to 8 hours, as needed
     children under 12 years do not use
    • Other Information
    • store at 20-25°C (68-77°F).
    • TAMPER EVIDENT: Do not use if safety seal under child-resistant cap is broken or missing.

Inactive Ingredients

magnesium stearate, microcrystalline cellulose, sodium starch glycolate.

Questions or comments?
Call weekdays between 10 a.m. to 4 p.m. CST, at 833-289-7626 or visit our website www.RoboCough.com to report serious adverse events associated with the use of this product. Please call a doctor for medical advice.

Distributed by:
DXM Pharmaceutical, Inc. 2717 Commercial Center Blvd., Suite E200
Katy, TX 77 494
www.RoboCough.com Patent Pending.

Image

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