Maximum Strength Cough Plus Chest Congestion Dm
FDA Label NDC 68210-4107

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Spirit Pharmaceuticals Llc for the product Maximum Strength Cough Plus Chest Congestion Dm (NDC 68210-4107). 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 other, otc - purpose, uses, otc - do not use, ask a doctor before use if you have, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

DISTRIBUTED BY:
SPIRIT PHARMACEUTICALS LLC

RONKONKOMA, NY 11779

Otc - Purpose

Active ingredients (in each softgel)Purposes
Dextromethorphan HBr, USP 10 mgCough suppressant
Guaifenesin, USP 200 mgExpectorant

Uses

  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

Otc - Do Not Use

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

  • cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

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

  • do not take more than 12 softgels 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 over2 softgels every 4 hours
    children under 12 yearsdo not use

Other Information

  • store at 20-25°C (68-77°F).
  • avoid excessive heat above 40°C (104°F).

Inactive Ingredients

FD&C Red-40, gelatin, glycerin, polyethylene glycol 400, povidone K30, propylene glycol, purified water, special sorbitol, titanium dioxide

Questions Or Comments?

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VALUMEDS TM

Compare to the active ingredients in Robitussin® Maximum

Strength Cough+Chest Congestion  DM*

Maximum Strength

Cough + Chest Congestion DM

DEXTROMETHORPHAN HBr / COUGH SUPPRESSANT
GUAIFENESIN/ EXPECTORANT

MAXIMUM STRENGTH

Relieves

  • cough
  •  mucus

    • 10 SOFTGELS
    Liquid Filled capsules

    Image Description (Valumeds)

    Image Description (Valumeds)

* Please review the disclaimer below.