Label: AKIN DM- dextromethorphan guaifenesin liquid
- NDC Code(s): 69822-201-04
- Packager: Southern Sales & Service, Inc.
- 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 January 4, 2017
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- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
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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 you are taking a prescription drug that contains an MAOI, ask a doctor or pharmacist before taking this product.
Ask a doctor before use if ° you have a cough that lasts or a chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema - cough occurs with too much phlegm (mucus) - Ask a doctor before use if
- Stop use and ask a doctor if
- If pregnant or breast-feeding
- DOSAGE & ADMINISTRATION
- PURPOSE
- Other Information
- Akin Cough Formula DM
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INGREDIENTS AND APPEARANCE
AKIN DM
dextromethorphan guaifenesin liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69822-201 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 5 mg in 5 mL GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 100 mg in 5 mL Inactive Ingredients Ingredient Name Strength PROPYLENE GLYCOL (UNII: 6DC9Q167V3) GLYCERIN (UNII: PDC6A3C0OX) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) SUCRALOSE (UNII: 96K6UQ3ZD4) SODIUM CITRATE (UNII: 1Q73Q2JULR) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) CHERRY (UNII: BUC5I9595W) MENTHOL (UNII: L7T10EIP3A) FD&C RED NO. 40 (UNII: WZB9127XOA) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69822-201-04 1 in 1 BOX 01/01/2015 1 118 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 01/04/2014 Labeler - Southern Sales & Service, Inc. (013114906) Establishment Name Address ID/FEI Business Operations Southern Sales & Service, Inc. 013114906 LABEL(69822-201) Establishment Name Address ID/FEI Business Operations GADAL Laboratories, Inc 841305639 MANUFACTURE(69822-201)