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Drug Facts
Distributed by:
Shield Pharmaceuticals Corp.
Ronkonkoma, NY 11779
Adult Long Lasting Cough Relief Capsule, Liquid Filled
FDA Label NDC 83059-0110
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Shield Pharmaceuticals Corp for the product Adult Long Lasting Cough Relief (NDC 83059-0110). 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 other, active ingredient (in each softgel), purpose, uses, otc - do not use, otc - ask doctor, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each Softgel)
Dextromethorphan HBr, USP 15 mg
Purpose
Cough suppressant
Uses
temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold.
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.
Otc - Ask Doctor
Ask a doctor before use if you have
• a cough that occurs with too much phlegm (mucus)
• a cough that lasts or is chronic as occurs with smoking, asthma, or emphysema
Otc - Stop Use
Stop use and ask a doctor ifcough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. 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).
Directions
do not take more than 8 softgels in any 24-hour period
this adult product is not intended for use in children under 12 years of age
| adults and children 12 years and over | take 2 softgels every 6 to 8 hours, as needed |
| children under 12 years | do not use |
Other Information
• store at controlled room temperature 20-25°C (68-77°F)
• avoid excessive heat above 40°C (104°F)
• protect from light
Questions Or Comments?
1-800-373-6981 (toll-free)
Inactive Ingredients
FD&C blue no. 1, FD&C red no. 40, FD&C yellow 6, gelatin, glycerin, polyethylene glycol 400, povidone (pvp k 30), propylene glycol, purified water, sorbitan, sorbitol solution*. *may contain this inactive ingredient
Principal Display Panel
ValuRx
Compare to the active ingredient in Robitussin® Long-Acting Coughgels®†
Up to 8 Hr. Relief
Adult Long-Lasting
Cough Relief
Dextromethorphan HBr
(Cough Suppressant)
Carton
Carton (Carton)
Label
Label (Label)
* Please review the disclaimer below.
