Label: DOMETUSS-NR- dextromethorphan hydrobromide, chlorpheniramine maleate, and phenylephrine hydrochloride tablet
- NDC Code(s): 53809-240-01
- Packager: Domel Laboratories
- 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 December 29, 2021
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
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Warnings
- Do not exceed recommended dosage
Do not use
- if you are now taken a prescription Monoaminooxidase Inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions or Parkinson's disease), or for two 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
- heart disease
- thyroid disease
- trouble urinating due to enlarged prostate gland
- glaucoma
- cough that occurs with too much phlegm(mucus)
- a breathing problem or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis or emphysema.
Stop using this product and ask a doctor if
- you get nervous, dizzy or sleepless
- cough lasts more than 7 days, comes back or is accompanied by fever, rash or persistent headaches, these could be signs of a serious condition.
When using this product
- Excitability may occur, especially in children
- May cause drowsiness
- alcohol, sedatives and tranquilizers may increase the drowsiness effect
- Avoid alcoholic beverages while taking this product
- Use caution when driving motor vehicle or operating machinery.
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label
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INGREDIENTS AND APPEARANCE
DOMETUSS-NR
dextromethorphan hydrobromide, chlorpheniramine maleate, and phenylephrine hydrochloride tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53809-240 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 CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE 4 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg Inactive Ingredients Ingredient Name Strength CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TALC (UNII: 7SEV7J4R1U) Product Characteristics Color WHITE Score 2 pieces Shape ROUND Size 13mm Flavor Imprint Code KL Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53809-240-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 01/21/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 01/21/2016 Labeler - Domel Laboratories (808198837) Establishment Name Address ID/FEI Business Operations Lex Inc 046172888 MANUFACTURE(53809-240)