Indications and uses
Temporarily relieves common cold/flu symptoms: ■ cough due to minor throat & bronchial irritation ■ nasal congestion due to hay fever ■ other upper respiratory allergies ■ sinus congestion and pressure ■ stuffy nose
Pulmo Calcio
- Manufacturer
- Procaps S.A. de C.V.
- Effective date
- 2022-06-27
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 21:58:01
Label at a glance#
ProductPulmo Calcio
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
Label structure8 sections
Dosage and administration
■ do not exceed recommended dosage ■ SHAKE WELL BEFORE USE ■ take every 4 hours; do not exceed 6 doses in a 24-hour period ■ adults and children 12 years of age and over: 1 teaspoonful (5mL), every 4 hours ■ children 12-6 years of age: ó teaspoon (2.5mL), every 4 hours ■ children under 6 years of age: do not use
Contacts and useful links#
Label contents#
Full prescribing information#
Drug Facts
Drug Facts
OTC - PURPOSE SECTION
Active ingredients (in each 1 teaspoonful (5mL)) | Purposes |
| Dextromethorphan HBr 20mg ................. | Cough suppressant |
| Phenylephrine HCl 10mg ........................ | Nasal decongestant |
Uses
Temporarily relieves common cold/flu symptoms:
■ cough due to minor throat &
bronchial irritation
■ nasal congestion due to hay fever
■ other upper respiratory allergies
■ sinus congestion and pressure
■ stuffy nose
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
■ heart disease
■ high blood pressure
■ thyroid disease
■ diabetes
■ a cough that is accompanied by excessive phlegm (mucus)
■ a persistent orchronic cough as occurs with smoking, asthma or emphysema
■ trouble urinating due toenlarged prostate gland
Stop Use and ask a Doctor if
■ a persistent cough or symptoms do not improve within 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
■ new symptoms occur
■ nervousness, dizziness, or sleeplessness occur
If pregnant or breast-feeding,
ask a health professional before use.
KEEP OUT OF REACH OF CHILDREN.
In case of accidental overdose, get medical help or contact a Poison Control Center right away.
Directions
■ do not exceed recommended dosage ■ SHAKE WELL BEFORE USE
■ take every 4 hours; do not exceed 6 doses in a 24-hour period
■ adults and children 12 years of age and over: 1 teaspoonful (5mL), every 4 hours
■ children 12-6 years of age: ó teaspoon (2.5mL), every 4 hours
■ children under 6 years of age: do not use
Other information
■ each teaspoonful (5mL) contains: sodium 4.7 mg
■ store at room temperature 59-86°F (15-30°C)
■ protect from excessive heat
Tamper evident: Do not use if the seal over the cap is broken.
Questions & Comments
Customer.Service@LabLopez.com.sv
+1-754-260-6479
Manufactured for/ Fabricado para: Procaps S.A de C.V., San Salvador, El Salvador Tel: (503) 2227-1934
Distributed by/ Distribuido por: Sofgen Pharmaceutical, Aventura, FL 33180
Package Label & Principal Display Panel
• Sugar FREE • Alcohol FREE
NDC 76864-464-03
Pulmo Calcio ®
Syrup
- Dextromethorphan HBr
- Phenylephrine HCl
Grape Flavor
4 fl.oz. (120 mL)
Products#
Every source-derived product name is available through these pages.
- Pulmo Calcio
- DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCl
- ANHYDROUS CITRIC ACID
- SODIUM CITRATE
- GLYCERIN
- METHYLPARABEN
- PROPYLENE GLYCOL
- PROPYLPARABEN
- WATER
- SUCRALOSE
- XANTHAN GUM
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 76864-464 | 76864-464-03 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| SODIUM CITRATE | 1Q73Q2JULR | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
| WATER | 059QF0KO0R | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| XANTHAN GUM | TTV12P4NEE | IACT |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| PHENYLEPHRINE HYDROCHLORIDE | 04JA59TNSJ | ACTIB |
Source Document#
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 |
|---|---|---|---|---|---|---|
| 0e0bfaf5-9e63-5821-e063-6294a90a7e1f | c6b31cfd-a576-1436-e053-2995a90acca4 | 2024-01-03 | Warnings | c6b31cfd-a576-1436-e053-2995a90acca4 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.