Label: ADULT TUSSIN COUGH AND CHEST CONGESTION DM SUGAR FREE- dextromethorphan hbr, guaifenesin liquid
- NDC Code(s): 71399-1006-4, 71399-1006-6, 71399-1006-8
- Packager: Akron Pharma 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 November 11, 2022
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- Official Label (Printer Friendly)
- Active ingredients (in each 10 mL)
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
- cough that occurs with too much phlegm (mucus)
- cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema
Stop use and ask a doctor if
cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
- do not take more than 6 doses in any 24-hour period
- measure only with dosing cup provided
- keep dosing cup with product
- mL= milliliter
- this adult product is not intended for use in children under 12 years of age
- adults and children 12 years and over: 10 mL every 4 hours
- children under 12 years: do not use
- Other information
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
ADULT TUSSIN COUGH AND CHEST CONGESTION DM SUGAR FREE
dextromethorphan hbr, guaifenesin liquid
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71399-1006 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 20 mg in 10 mL GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 200 mg in 10 mL Inactive Ingredients Ingredient Name Strength ACESULFAME POTASSIUM (UNII: 23OV73Q5G9) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) GLYCERIN (UNII: PDC6A3C0OX) MENTHOL (UNII: L7T10EIP3A) WATER (UNII: 059QF0KO0R) SORBITOL SOLUTION 70% (UNII: 8KW3E207O2) SODIUM CITRATE (UNII: 1Q73Q2JULR) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM BENZOATE (UNII: OJ245FE5EU) Product Characteristics Color white (colorless) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71399-1006-4 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/11/2022 2 NDC:71399-1006-8 236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/11/2022 3 NDC:71399-1006-6 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/11/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 11/11/2022 Labeler - Akron Pharma Inc. (067878881) Registrant - SLV PHARMACEUTICALS LLC (081225162) Establishment Name Address ID/FEI Business Operations SLV PHARMACEUTICALS LLC 081225162 manufacture(71399-1006)