Active Ingredient - (Per Tablet)
Dextromethorphan Hydrobromide 20mg Cough Suppressant
Guaifenesin 400mg Expectorant
Reeses Tabtussin
FDA Label NDC 10956-161
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Reese Pharmaceutical Co for the product Reeses Tabtussin (NDC 10956-161). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient - (per tablet), ask doctor before use if you have, stop use and ask doctor if, do not use, keep out of reach of children, if pregnant or breastfeeding, inactive ingredients, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Ask Doctor Before Use If You Have
persistent or chronic cough, such as occurs with smoking, asthma, bronchitis or emphysma
cough is accompanied by excessive phlegm (mucous)
Stop Use And Ask Doctor If
Symptoms are accompanied by fever, rash or persistent headache
cough persists for more than 1 week or tends to recur
A persistent cough may be a sign of a serious condition
Do Not Use
If you are now taking a prescription monoamine oxidase (inhiMor~MAIO)
Certain drugs for depression, psychiatric or emotional conditioners or Parkinson's disease
or for 2 weeks after stopping MAIO drug, If you do not know if your prescription drug contains
an MAIO, ask your doctor or pharmacist before using this product.
Keep Out Of Reach Of Children
In ase of overdose, get medical help or contact a Poison Center immediately
If Pregnant Or Breastfeeding
Ask a health professional before use.
Inactive Ingredients
magnesium stearate, maltodextrin, microcrystalline cellulose, povidone K30, povidone 90F, silicon dioxide, stearic acid.
Directions
• Adults and children 12 years of age and over: take 1 tablet every 4 hours as needed
• Children 610 under 12 years of age: take 1/2 tablet every 4 hours as needed
• Children under 6 years of age: consult a doctor
Do not exceed 6 doses in a 24 hour period or as directed by a doctor
Other information store at 15'- 30' C (59'- 86'F) Rev 10/U9 RCCF
Uses
Temporarily relieves cough due to minor throat and bronchial irritation
as may occur with a common cold • helps loosen phlegm (mucus) and thin
bronchial secretions to rid the bronchial passageways of bothersome mucus
• helps make coughs more productive
Purpose
Cough Suppressant
Expectorant
Warnings
Do not use if you are now taking a prescription monoamine oxidase (inhiMor~MAIO)
Certain drugs for depression, psychiatric or emotional conditioners or Parkinson's disease
or for 2 weeks after stopping MAIO drug, If you do not know if your prescription drug contains
an MAIO, ask your doctor or pharmacist before using this product.
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Package Label (Carton)
Distributed By
Reese Pharmaceutical Company
10617 Frank Ave., Cleveland, Ohio 44106 • 1-800-321-7178
www.reesepharmaceutical.com • [email protected]
REV 3/21 TDMTR
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