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Drug Facts
Westussin Dm Nf Liquid
FDA Label NDC 69367-353
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 Westussin Dm Nf (NDC 69367-353). 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, warnings, do not use this product, ask a doctor before use if you have, otc - ask doctor/pharmacist, when using this product, 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 5 mL teaspoonful) | Purpose |
|---|---|
| Dexbrompheniramine Maleate 2 mg | Antihistamine |
| Dextromethorphan Hydrobromide 15 mg | Cough Suppressant |
| Phenylephrine Hydrochloride 7.5 mg | Nasal Decongestant |
Uses
Uses temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:
- runny nose
- sneezing
- itching of nose or throat
- itchy, watery eyes
- cough due to minor throat and bronchial irritation
- nasal congestion
- reduces swelling of nasal passages
Warnings
Do not exceed recommended dosage.
Do Not Use This Product
- 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
- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
- trouble urinating due to an enlarged prostate gland
- a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
- a cough that occurs with too much phlegm (mucus)
- heart disease
- high blood pressure
- thyroid disease
- diabetes
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.
When Using This Product
- excitability may occur, especially in children
- may cause marked drowsiness
- avoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase the drowsiness effect
- use caution when driving a motor vehicle or operating machinery
Stop Use And Ask A Doctor If
- nervousness, dizziness, or sleeplessness occur
- cough or nasal congestion persists for more than 1 week, tends to recur, or is 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 breastfeeding 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 exceed recommended dosage
| Adults and children 12 years of age and over: | 1 teaspoonful (5 mL) every 4 to 6 hours, not to exceed 6 teaspoonfuls in 24 hours |
| Children 6 to under 12 years of age: | 1/2 teaspoonful (2.5 mL) every 4 to 6 hours, not to exceed 3 teaspoonfuls in 24 hours |
| Children under 6 years of age | Consult a doctor. |
Other Information
Store at 59° - 86°F (15° - 30°C)
Inactive Ingredients
Citric acid anhydrous, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, trisodium citrate dihydrate.
Questions?
Call weekdays from 9 AM to 5 PM EST at 1-844-221-7294. You may also report serious side effects to this phone number
Principal Display Panel - 473 Ml Bottle Label
NDC 69367-353-16
WesTussin DM NF
Antihistamine • Cough Suppressant
• Nasal Decongestant
SUGAR FREE / ALCOHOL FREE
DYE FREE / GLUTEN FREE
Each 5 mL (1 teaspoonful) contains:
Dexbrompheniramine Maleate
2 mg
Dextromethorphan HBr
15 mg
Phenylephrine HCl
7.5 mg
Strawberry Flavor
TAMPER EVIDENT: Tamper evident by foil seal under
cap. Do not use if foil seal is broken or missing.
16 OZ (473 mL)
Westminster
Pharmaceuticals
Principal Display Panel (473 mL Bottle Label)
* Please review the disclaimer below.
