Label: ADULT LONG LASTING-COUGH RELIEF- dextromethorphan hbr,usp capsule
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Contains inactivated NDC Code(s)
NDC Code(s): 68016-026-20 - Packager: Chain Drug Consortium LLC
- Category: HUMAN OTC DRUG LABEL
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 May 21, 2013
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT(S)
- PURPOSE
- USE(S)
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WARNINGS
DO NOT USEYou 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
- STOP USE AND ASK DOCTOR IF
- PREGNANCY/BREASTFEEDING
- KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- STORAGE
- INACTIVE INGREDIENTS
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PRINCIPAL DISPLAY PANEL
CARTON LABEL PDP
NDC # 68016-026-20
Adult Long-Lasting Cough Relief
DEXTROMETHORPHAN HBr, USP 15mg
COUGH SUPPRESSANT
Relieves cough for upto 8 hours
Non-drowsy
Non-Narcotic formula
20 softgels
BOTTLE LABEL PDP
NDC # 68016-026-20
Adult Long-Lasting Cough Relief
DEXTROMETHORPHAN HBr, USP 15mg
COUGH SUPPRESSANT
Relieves cough for about 8 hours
Non-Drowsy
Non-Narcotic Formula
20 Softgels
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INGREDIENTS AND APPEARANCE
ADULT LONG LASTING-COUGH RELIEF
dextromethorphan hbr,usp capsuleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68016-026 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 GELATIN (UNII: 2G86QN327L) SORBITAN (UNII: 6O92ICV9RU) SORBITOL (UNII: 506T60A25R) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) WATER (UNII: 059QF0KO0R) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) POVIDONE K30 (UNII: U725QWY32X) GLYCERIN (UNII: PDC6A3C0OX) FD&C RED NO. 40 (UNII: WZB9127XOA) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) Product Characteristics Color RED Score no score Shape CAPSULE Size 13mm Flavor Imprint Code 26 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68016-026-20 1 in 1 CARTON 1 20 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 05/22/2013 Labeler - Chain Drug Consortium LLC (101668460) Registrant - Chain Drug Consortium LLC (101668460) Establishment Name Address ID/FEI Business Operations Marksans Pharma Limited 925822975 MANUFACTURE(68016-026)