Label: TUSSIN CF- dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride liquid
- 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.
Updated December 30, 2013
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- ACTIVE INGREDIENT
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) or a cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema, trouble urinating due to an enlarged prostate gland
Do not exceed recommended dose
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.
- Other information
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 237 mL Bottle Label
INGREDIENTS AND APPEARANCE
dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride liquid
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76140-105 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide 10 mg in 5 mL Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin 100 mg in 5 mL Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride 5 mg in 5 mL Inactive Ingredients Ingredient Name Strength Sodium Benzoate (UNII: OJ245FE5EU) Citric Acid Monohydrate (UNII: 2968PHW8QP) Sorbitol (UNII: 506T60A25R) Saccharin Sodium (UNII: SB8ZUX40TY) Sucralose (UNII: 96K6UQ3ZD4) FD&C Red NO. 40 (UNII: WZB9127XOA) Propylene Glycol (UNII: 6DC9Q167V3) Glycerin (UNII: PDC6A3C0OX) Sodium Citrate (UNII: 1Q73Q2JULR) Menthol (UNII: L7T10EIP3A) Water (UNII: 059QF0KO0R) Product Characteristics Color RED Score Shape Size Flavor CHERRY, FRUIT, MENTHOL Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76140-105-08 1 in 1 CARTON 1 236 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 04/10/2013 Labeler - davAgen Pharmaceutical, LLC (967545935) Establishment Name Address ID/FEI Business Operations davAgen Pharmaceutical, LLC 967545935 MANUFACTURE(76140-105) , PACK(76140-105) , LABEL(76140-105) , ANALYSIS(76140-105)