RESFRIDOL ANTITUSSIVE- guaifenesin, dextromethorphan hbr suspension

Resfridol Antitussive by

Drug Labeling and Warnings

Resfridol Antitussive by is a Otc medication manufactured, distributed, or labeled by Laboratorios Alfa. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients and Purposes

• Active ingredients (in each 10 mL): Purposes
• Guaifenesin 200 mg ............................................................................: Expectorant
• Dextromethorphan HBr 30 mg..................................................: Cough suppressant

Uses

Temporarily relieves common cold symptoms:

• cough due to minor throat & bronchial irritation
• helps loosen phlegm (mucus) and thin bronchial secretions to:
• drain bronchial tubes
• make coughs more productive

Warnings

Ask a doctor or pharmacist before 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.
• have a persistent or chronic cough such as occurs with smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus)

Stop use and ask a doctor if

a cough persists for more than 7 days, tends to recur, or is accompanied by fever, rash or persistent headache. These could be signs of a serious condition.

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. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

• do not exceed recommended dosage
• do not exceed 4 doses in a 24-hour period
• adults & children 12 year of age & over: 1 teaspoonful (10 mL), every 6 hours
• children 6 to under 12 years of age: 1/2 teaspoonful (5 mL), every 6 hours
• children under 6 years of age: do not use

Other information

Other information

• store at room temperature between 77-86°F (25-30°C) TAMPER EVIDENT: Do not use if safety seal over cap is broken, torn, or missing.

Other information

• store at room temperature between 77-86°F (25-30°C) TAMPER EVIDENT: Do not use if safety seal over cap is broken, torn, or missing.

Inactive ingredients

artificial flavors, citric acid, FD&C red no.40, sodium benzoate, sorbitol, sucralose, water

Questions?

+1-809-544-0222 (M-F) 9 AM to 5 PM Eastern or www.laboratoriosalfa.com

Principal Display Panel

Resfridol

Antitussive

Syrup

• Cough Suppressant
• Expectorant

Dextromethorphan Hbr and Guaifenesin

4 fl oz (120mL)

INGREDIENTS AND APPEARANCE

RESFRIDOL ANTITUSSIVE 
guaifenesin, dextromethorphan hbr suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72483-100
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	30 mg  in 10 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
FD&C RED NO. 40 (UNII: WZB9127XOA)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72483-100-04	1 in 1 BOX	08/01/2019
1		120 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	08/01/2019

Labeler - Laboratorios Alfa (815941244)