Robafen Cough Formula
FDA Label NDC 61786-963

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Remedyrepack Inc. for the product Robafen Cough Formula (NDC 61786-963). 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, active ingredient (in each 2 tsp (10 ml) ), purpose, uses, 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
MAJOR ® PHARMACEUTICALS
17177 N Laurel Park Drive, Suite 233,
Livonia, MI 48152

Active Ingredient (In Each 2 Tsp (10 Ml) )

Guaifenesin USP 200 mg

Purpose

Expectorant

Uses

helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

Ask A Doctor Before Use If You Have

  • a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
  • a cough occurs with too much phlegm (mucus)

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 the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

  • do not take more than 6 doses in any 24 hour period
  • this product is not intended for use in children under 12 years of age
  • TSP = teaspoonful
    • adults and children 12 years and over2 - 4 TSP every 4 hours
    children under 12 yearsdo not use

Other Information

  • each TSP (5 mL) contains: sodium 3 mg
  • store at 20°-25°C (68°-77°F). Do not refrigerate.

Inactive Ingredients

caramel powder, citric acid, corn syrup, FD&C Red #40, glycerin, menthol, propylene glycol, purified water, saccharin sodium, sodium benzoate

Questions Or Comments?

(800) 616-2471

Package Label.Principal Display Panel

DRUG: ROBAFEN COUGH FORMULA

GENERIC: Guaifenesin

DOSAGE: SYRUP

ADMINSTRATION: ORAL

NDC: 61786-963-45

COLOR: brown

FLAVOR: MENTHOL

PACKAGING: 118 mL in 1 BOTTLE

ACTIVE INGREDIENT(S):

  • Guaifenesin 100mg in 5mL

    • INACTIVE INGREDIENT(S):

    • Corn Syrup
    • FD&C Red no. 40
    • Menthol, Unspecified Form
    • Caramel
    • Water
    • Glycerin
    • Sodium Benzoate
    • Propylene Glycol
    • Anhydrous Citric Acid
    • Saccharin Sodium

      • Remedy_label (Remedy Label)

      Remedy_label (Remedy Label)

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