The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active ingredient (in each 5 mL)Dextromethorphan polistirex equivalent to 30 mg dextromethorphan hydrobromide, USP
Otc - Purpose
Indications & Usage
- Usestemporarily relieves •cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants •the impulse to cough to help you get to sleep
Otc - Do Not Use
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.
Allergy AlertContains sodium metabisulfite, a sulfite that may cause allergic-type reactions.
Distributed by: Pfizer, Madison, NJ 07940 USA © 2016 Pfizer Inc.
Otc - Ask Doctor
- Ask a doctor before use if you have •chronic cough that lasts as occurs with smoking, asthma, or emphysema •cough that occurs with too much phlegm (mucus)
Otc - Stop Use
- Stop use and ask a doctor if •side effects occur. You may report side effects to FDA at 1-800-FDA-1088. •cough lasts more than 7 days, cough comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away 1-800-222-1222.
Dosage & Administration
- Directions •shake bottle well before use •measure only with dosing cup provided. Do not use dosing cup with other products •dose as follows or as directed by doctor •mL = milliliteradults and children 12 years of age and over10 mL every 12 hours, not to exceed 20 mL in 24 hourschildren 6 to under 12 years of age5 mL every 12 hours, not to exceed 10 mL in 24 hourschildren 4 to under 6 years of age2.5 mL every 12 hours, not to exceed 5 mL in 24 hourschildren under 4 years of agedo not use
Storage And Handling
- Other information •each 5 mL contains: sodium 5 mg •store at 20–25°C (68–77°F) •dosing cup provided
Inactive Ingredients (Grape Flavor)
D&C red no. 30, FD&C blue no. 1, flavor, glycerin, high fructose corn syrup, methylparaben, polysorbate 80, polyvinyl acetate, povidone, propylparaben, purified water, sodium metabisulfite, sodium polystyrene sulfonate, sucrose, tartaric acid, tragacanth gum, triacetin, xanthan gum
Inactive Ingredients (Orange Flavor)
D&C red no. 30, D&C yellow no. 10, flavor, glycerin, high fructose corn syrup, methylparaben, polysorbate 80, polyvinyl acetate, povidone, propylparaben, purified water, sodium metabisulfite, sodium polystyrene sulfonate, sucrose, tartaric acid, tragacanth gum, triacetin, xanthan gum
Otc - Questions
Questions?call weekdays from 9 AM to 5 PM EST at 1-800-762-4675.You may also report side effects to this number.For most recent product information, visit www.robitussin.com
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