Recall of Robitussin DM

July 09, 2012

Last July 6, 2012, DOH-FDA released their advisory regarding the voluntary recall of Robitussin DM by Pfizer Consumer Healthcare. The said product was withdrawn from the market due to error found in its primary and carton label. The erroneous label was specifically seen in the dosage instruction for age group 2 to under 6 years old. 2.5 ml is equivalent to 1/2 teaspoonful and NOT 1 teaspoonful.

DOH-FDA advised the public to contact the said establishment if they have bought the affected products. For pharmacist and pharmacy owners, please check your stock and coordinate with your supplier. 
You may contact Pfizer, Inc.for more details.
23/F Ayala Life-FGU Center,
6811 Ayala Ave., Makati City.
Trunkline: +63 2 451-9200
Pfizer Healthline

Metro Manila: +63 2 671-1000 PLDT Provincial Tollfree: 1-800-10-6711000 Digitel Provincial Tollfree: 1-800-3-6711000 _____________________________

Product Information

Generic Name: Dextromethorphan HBr, Guiafenesin 

Brand Name: Robitussin DM

Contents: In every 5 ml of the syrup, 15 mg of Detromethorphan HBr, 100 mg of Guiafenesin, 1.4% Alcohol

Indication and Usage:

Robitussin DM is can be bought over-the-counter. It is commonly given if coughs is associated with acute head/chest cold, bronchitis, laryngitis, pharyngitis, tracheitis, pertussis, influenza, and measles. It acts by loosening and clearing chest congestion and by reducing the frequency of coughing. Robirussin DM can be taken with or without food with the following dosage:

• Adult: 1-2 teaspoon every 6 hours (maximum of 8 tsp/day)
• Children 6 to 12 years old: 1 teaspoon every 6 (maximum of 4 tsp/day)
• 2-6 years old: 1/2 teaspoon every 6 hours or as directed

Contraindication: 

It is contraindicated for patients receiving Monoamine oxidase inhibitors (MAOIs) or within two weeks of taking MAOIs.

Adverse Drug Reactions:

Nausea, vomiting, somnolence, hypersensitivity, dizzines and excitability. Altered sensory perception, ataxia, slurred speech and dysphoria may experience in the event of overdose in adult. While overdose in children may result to ataxia, respiratory depression and convulsion.

Packaging:

Robitussin DM Syrup can be bought in 60ml or 120 ml.

Source: DOH-FDA Advisory 2012-006

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