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Drug Facts
Dextromethorphan Hydrobromide, Guaifenesin, And Phenylephrine Hydrochloride Liquid
FDA Label NDC 69367-184
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Westminster Pharmaceuticals, Llc for the product Dextromethorphan Hydrobromide, Guaifenesin, And Phenylephrine Hydrochloride (NDC 69367-184). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - purpose, uses, otc - do not use, ask a doctor before use if you have, otc - when using, stop use and ask a doctor if, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
| Active ingredients (in each 15 mL (TBSP)) | Purpose |
|---|---|
| Dextromethorphan HBr 18 mg | Cough Suppressant |
| Guaifenesin 200 mg | Expectorant |
| Phenylephrine HCl 10 mg | Nasal Decongestant |
Uses
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
- temporarily relieves:
- cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
- the intensity of coughing
- the impulse to cough to help you get to sleep
- nasal congestion due to a cold
Otc - Do Not Use
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
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- a cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema
- a cough that occurs with too much phlegm (mucus)
- difficulty in urination due to enlargement of the prostate gland
Otc - When Using
When using this product do not use more than directed
Stop Use And Ask A Doctor If
- nervousness, dizziness or sleeplessness occurs
- symptoms do not improve within 7 days or are accompanied by a fever, rash or persistent headache. A persistent cough may be a sign of a serious condition.
- new symptoms occur
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- do not take more than 6 doses in any 24-hour period
- dose as follows or as directed by a doctor
| Adults and children 12 years of age and over: | 1 tablespoon every 4 hours, not to exceed 6 tablespoons in a 24 hour period. |
| Children 6 to under 12 years of age: | 1/2 tablespoon every 4 hours, not to exceed 3 tablespoons in a 24 hour period. |
| Children under 6 years of age: | Consult a doctor. |
Other Information
- store at controlled room temperature 59°-86°F (15°-30°C)
Inactive Ingredients
Citric acid, methylparaben, potassium citrate, potassium sorbate, propylene glycol, propylparaben, purified water, raspberry flavor, sorbitol, sucralose
Questions Or Comments?
- Call 1-844-221-7294
Principal Display Panel - 240 Ml Bottle Label
NDC 69367-184-08
Cough
Cold/Congestion
Dextromethorphan HBr
Guaifenesin
Phenylephrine HCl
Each 15 mL (TBSP) contains:
Dextromethorphan HBr 18 mg
Guaifenesin 200 mg
Phenylephrine HCl 10 mg
Cough Suppressant • Expectorant • Nasal Decongestant
Raspberry Flavor
Alcohol Free / Sugar Free
Gluten Free / Dye Free
8 fl. oz. (240 mL)
Westminster
Pharmaceuticals
Principal Display Panel (240 mL Bottle Label)
* Please review the disclaimer below.
