Label: COUGH RELIEF 15 MG- dextromethorphan hbr capsule, liquid filled
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- NDC Code(s): 81179-015-00
- Packager: YET HEALTH GROUP LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated September 22, 2021
If you are a consumer or patient please visit this version.
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Warnings
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.
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
Stop use and ask a doctor if cough 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.
If pregnant or breast-feeding, ask a health professional before use.
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INGREDIENTS AND APPEARANCE
COUGH RELIEF 15 MG
dextromethorphan hbr capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81179-015 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 15 mg Inactive Ingredients Ingredient Name Strength FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) POVIDONE (UNII: FZ989GH94E) WATER (UNII: 059QF0KO0R) SORBITOL SOLUTION 70% (UNII: 8KW3E207O2) SORBITAN (UNII: 6O92ICV9RU) SORBITOL (UNII: 506T60A25R) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color red Score no score Shape OVAL Size 13mm Flavor Imprint Code IS3 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81179-015-00 150 in 1 BOTTLE; Type 0: Not a Combination Product 05/05/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 05/05/2021 Labeler - YET HEALTH GROUP LLC (117763296)
