Label: DOMETUSS- chlorpheniramine maleate, dextromethorphan hydrobromide, and phenylephrine hydrochloride syrup
- NDC Code(s): 53809-202-04
- Packager: Domel Laboratories
- 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 December 15, 2022
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- USE
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WARNINGS
DO NOT USE
- to sedate a child or to make a child sleepy
- 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
- heart disease
- thyroid disease
- trouble urinating due to enlarged prostate gland
- glaucoma
- cough that occurs with too much phlegm (mucus)
- a breathing problems or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis or emphysema
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When using this product
DO NOT EXCEED RECOMMENDED DOSAGE - may cause marked drowsiness
- avoid alcoholic beverages
- Alcohol, sedatives, and tranquilizers may cause increased drowsiness
- be careful when driving a motor vehicle or operating machinery
- excitability may occur, especially with children.
- Directions
- Other Information
- Tamper-Evident Disclosure
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label
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INGREDIENTS AND APPEARANCE
DOMETUSS
chlorpheniramine maleate, dextromethorphan hydrobromide, and phenylephrine hydrochloride syrupProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53809-202 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE 4 mg in 5 mL DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 20 mg in 5 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg in 5 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) GLYCERIN (UNII: PDC6A3C0OX) HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) (UNII: S38J6RZN16) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color Score Shape Size Flavor GRAPE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53809-202-04 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/01/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 08/01/2015 Labeler - Domel Laboratories (808198837)