Pulmo Calcio (Deactivated)

Pulmo Calcio by

Drug Labeling and Warnings

Pulmo Calcio by is a Otc medication manufactured, distributed, or labeled by Procaps S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PULMO CALCIO- dextromethorphan hbr, phenylephrine hcl syrup 
Procaps S.A. de C.V.

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Pulmo Calcio (Deactivated)

Drug Facts

Drug Facts

Active ingredients & Purposes

• 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.

Inactive ingredients

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)

PULMO CALCIO 
dextromethorphan hbr, phenylephrine hcl syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76864-464
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color		Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76864-464-03	1 in 1 CARTON	07/01/2021	07/01/2023
1		120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	07/01/2021	07/01/2023

Labeler - Procaps S.A. de C.V. (851259341)

Revised: 1/2024

Document Id: 0e0bfaf5-9e63-5821-e063-6294a90a7e1f

34390-5

Set id: c6b31cfd-a576-1436-e053-2995a90acca4

Version: 5

Effective Time: 20240103