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NDC 69367-0334-16 WesTussin DM 1; 10; 5 mg/5mL; mg/5mL; mg/5mL Details
WesTussin DM 1; 10; 5 mg/5mL; mg/5mL; mg/5mL
WesTussin DM is a ORAL SYRUP in the HUMAN OTC DRUG category. It is labeled and distributed by Westminster Pharmaceuticals, LLC. The primary component is DEXCHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE.
MedlinePlus Drug Summary
Chlorpheniramine relieves red, itchy, watery eyes; sneezing; itchy nose or throat; and runny nose caused by allergies, hay fever, and the common cold. Chlorpheniramine helps control the symptoms of cold or allergies but will not treat the cause of the symptoms or speed recovery. Chlorpheniramine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.
Related Packages: 69367-0334-16Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Chlorpheniramine
Dextromethorphan is used to temporarily relieve cough caused by the common cold, the flu, or other conditions. Dextromethorphan will relieve a cough but will not treat the cause of the cough or speed recovery. Dextromethorphan is in a class of medications called antitussives. It works by decreasing activity in the part of the brain that causes coughing.
Related Packages: 69367-0334-16Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Dextromethorphan
Phenylephrine is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Phenylephrine will relieve symptoms but will not treat the cause of the symptoms or speed recovery. Phenylephrine is in a class of medications called nasal decongestants. It works by reducing swelling of the blood vessels in the nasal passages.
Related Packages: 69367-0334-16Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Phenylephrine
Product Information
| NDC | 69367-0334 |
|---|---|
| Product ID | 69367-334_08a5f7d6-6f1b-4d1c-8f06-1672bda7ea3a |
| Associated GPIs | 43995803781220 |
| GCN Sequence Number | 078018 |
| GCN Sequence Number Description | dexchlorphen/phenylephrine/DM SYRUP 1-5-10MG/5 ORAL |
| HIC3 | B3R |
| HIC3 Description | NON-OPIOID ANTITUS-1ST GEN.ANTIHISTAMINE-DECONGEST |
| GCN | 44218 |
| HICL Sequence Number | 044697 |
| HICL Sequence Number Description | DEXCHLORPHENIRAMINE MALEATE/PHENYLEPHRINE/DEXTROMETHORPHAN |
| Brand/Generic | Generic |
| Proprietary Name | WesTussin DM |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | dexchlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SYRUP |
| Route | ORAL |
| Active Ingredient Strength | 1; 10; 5 |
| Active Ingredient Units | mg/5mL; mg/5mL; mg/5mL |
| Substance Name | DEXCHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE |
| Labeler Name | Westminster Pharmaceuticals, LLC |
| Pharmaceutical Class | Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 69367-0334-16 (69367033416)
| NDC Package Code | 69367-334-16 |
|---|---|
| Billing NDC | 69367033416 |
| Package | 480 mL in 1 BOTTLE, PLASTIC (69367-334-16) |
| Marketing Start Date | 2021-07-29 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.04407 |
| Pricing Unit | ML |
| Effective Date | 2023-12-20 |
| NDC Description | WESTUSSIN DM 1-5-10 MG/5 ML SYR |
| Pharmacy Type Indicator | C/I |
| OTC | Y |
| Explanation Code | 4, 5 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |
Standard Product Labeling (SPL)/Prescribing Information SPL 68a0cd44-3fdd-430e-af1a-498d4415ab78 Details
SPL UNCLASSIFIED SECTION
Uses
- temporarily relieves cough due to minor throat and bronchial irritation occurring with a cold or inhaled irritants
- temporarily relieves nasal congestion due to the common cold, hay fever or other respiratory allergies
- temporarily relieves these symptoms due to hay fever (allergic rhinitis):
- runny nose
- sneezing
- itching of the nose of throat
- itchy, watery eyes
- temporarily restores freer breathing through the nose
Warnings
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 breathing problem such as emphysema or chronic bronchitis
- glaucoma
- difficulty in urination due to enlarged prostate gland
- persistent or chronic cough such as occurs with smoking, asthma or emphysema
- cough accompanied by excessive phlegm (mucus)
When using this product
- do not exceed recommended dosage
- marked drowsiness may occur
- alcohol, sedatives, and tranquilizers may increase the drowsiness effect
- avoid alcoholic beverages
- use caution when driving a motor vehicle or operating machinery
- excitability may occur especially in children
Stop use and ask a doctor if
- cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash or persistent headache. A persistent cough may be a sign of a serious condition.
- symptoms do not improve within 7 days or are accompanied by fever
- nervousness, dizziness, or sleeplessness occur
Directions
Inactive ingredients
Questions?
PRINCIPAL DISPLAY PANEL - 480 mL Bottle Label
NDC 69367-334-16
WesTussin DM
Antihistamine • Cough Suppressant
Nasal Decongestant
• Alcohol Free • Dye Free
• Sugar Free • Gluten Free
Each 5 mL (1 teaspoonful) contains:
Dexchlorpheniramine Maleate
1 mg
Dextromethorphan HBr
10 mg
Phenylephrine HCl
5 mg
Cotton Candy Flavor
TAMPER EVIDENT: Tamper evident by foil
seal under cap. Do not use if foil seal is
broken or missing.
16 oz (480 mL)
Westminster
Pharmaceuticals
INGREDIENTS AND APPEARANCE
| WESTUSSIN DM
dexchlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl syrup |
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| Labeler - Westminster Pharmaceuticals, LLC (079516651) |