Giltuss Cough and Cold - Gil Pharmaceutical Corp
- Manufacturer
- Gil Pharmaceutical Corp
- Effective date
- 2026-07-23
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 8
- Source
- daily-update
- Hydrated at
- 2026-07-28 05:10:16
Label at a glance#
ProductGiltuss Cough and Cold
Active ingredientGUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
Label structure10 sections
Contacts and useful links#
Label contents#
Full prescribing information#
Drug Facts
Active Ingredients (in each tablet)
Dextromethorphan HBr, 28 mg
Guaifenesin, 388 mg
Phenylephrine HCl, 10 mg
OTC - PURPOSE SECTION
Purposes
Antitussive
Expectorant
Nasal Decongestant
INDICATIONS & USAGE SECTION
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.
WARNINGS SECTION
Warnings
OTC - DO NOT USE SECTION
Do not usemore 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.
OTC - ASK DOCTOR SECTION
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
OTC - STOP USE SECTION
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.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding,ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of the reach of children.In case of accidental overdose, get medical help or contact a Poison Control Center immediately.
DOSAGE & ADMINISTRATION SECTION
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.
SPL UNCLASSIFIED SECTION
Other information
- Store at room temperature, USP
- Do not use if blister seal is broken
INACTIVE INGREDIENT SECTION
Inactive ingredientsCroscarmellose Sodium, Dicalcium Phosphate, Hypromellose, Magnesium Silicate, Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, Mineral Oil, Polyvinylpyrrolidone, Silica, Sodium Lauryl Sulfate, Stearic Acid, Titanium Dioxide and Triacetin.
OTC - QUESTIONS SECTION
Questions or Comments?Call 787-848-9114, Mon.-Fri. 9:00 a.m. thru 5:00 p.m. EST. Call your doctor for medical advice in the event of side effects.
SPL UNCLASSIFIED SECTION
MANUFACTURED FOR GIL PHARMACEUTICAL CORP.
PONCE, PUERTO RICO 00717-1565
giltuss.com
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
MAXIMUM STRENGTH
Giltuss ®
COUGH & COLD
20 TABLETS
SUGAR FREE. DYE FREE. PRESERVATIVE FREE.
RELIEVES
- COUGH AND COLD
- CHEST CONGESTION
- LOOSENS PHLEGM AND MUCUS
- STUFFY NOSE
- NASAL CONGESTION
- SINUS PRESSURE
DailyMed Product Concepts#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 58552-331-20 | EA - Each | 58552-331 | d108afdb-aecd-4da1-97e1-bd810c74905c | 1 | 2019-04-11 |
Products#
Every source-derived product name is available through these pages.
- Giltuss Cough and Cold
- Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
- GUAIFENESIN
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
- CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE
- HYPROMELLOSE, UNSPECIFIED
- MAGNESIUM STEARATE
- MALTODEXTRIN
- CELLULOSE, MICROCRYSTALLINE
- LIGHT MINERAL OIL
- POVIDONE K30
- SILICON DIOXIDE
- SODIUM LAURYL SULFATE
- STEARIC ACID
- TITANIUM DIOXIDE
- TRIACETIN
- TALC
- CROSCARMELLOSE SODIUM
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 58552-331 | 58552-331-20 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 7 | 2025-10-09 | full-release | 2026-06-01 01:38:35 |
| 6 | 2025-03-10 | full-release | 2026-06-01 00:57:04 |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Giltuss Cough and Cold | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Gil Pharmaceutical Corp | 8590fcc9-c0dd-f43b-e053-2991aa0a692e | 2026-07-23 | Warnings | 58552-331-20 58552-331 58552033120 5746a790-450c-79d7-e063-6394a90a7077 8590fcc9-c0dd-f43b-e053-2991aa0a692e |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.