Giltuss Cough and Cold

Giltuss Cough and Cold is an FDA-registered drug product whose active ingredient is DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL. It is labelled by Gil Pharmaceutical Corp taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 58552-331, application M012, label effective 20260723. It is one of 14 FDA drug label records sharing the active ingredient DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL are most often described in connection with: temporarily relieves, symptoms associated, common cold, hay fever, upper respiratory, allergies helps, loosen phlegm, mucus loosens. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses Temporarily relieves the symptoms associated with a cough, the common cold, hay fever, or other upper respiratory allergies. Helps loosen phlegm (mucus), loosens nasal congestion, thin bronchial secretions, drain bronchial tubes, make coughs more productive, clear stuffy nose, clear nasal passageways, and shrinks swollen membranes.

Directions • Adults and Children 12 years and over: Take 1 tablet every 6 to 8 hours. Do not take more than 4 tablets in a 24 hour period. • Children 6 to 12 years of age: Take 1/2 tablet every 6 to 8 hours. Do not take more than 2 tablets in a 24-hour period. • Children under 6 years of age: Consult a physician.

Warnings Do not use more than the recommended dosage or 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 are uncertain whether your prescription drug contains an MAOI, ask a health professional. Ask a doctor before use if you have: heart disease excessive phlegm (mucus) high blood pressure diabetes thyroid disease difficulty in urination due to enlargement of the prostate gland persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema Stop use and ask a doctor if: nervousness, dizziness, or sleeplessness occurs symptoms are accompanied by fever, rash, persistent headache, or excessive phlegm (mucus) cough and congestion do not improve within 7 days or tend to recur These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of the reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center immediately.

FDA lists 14 drug label records with DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

What is Giltuss Cough and Cold used for?
Uses Temporarily relieves the symptoms associated with a cough, the common cold, hay fever, or other upper respiratory allergies. Helps loosen phlegm (mucus), loosens nasal congestion, thin bronchial secretions, drain bronchial tubes, make coughs more productive, clear stuffy nose, clear nasal passageways, and shrinks swollen membranes.

Who makes Giltuss Cough and Cold?
Gil Pharmaceutical Corp is the labeler of record for Giltuss Cough and Cold. 14 FDA label records share the active ingredient DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Giltuss Cough and Cold come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Giltuss Cough and Cold prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL?
Yes. 14 FDA drug label records list DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Giltuss Cough and Cold been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.