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NDC 50991-0121-16 Polytussin DM 2; 15; 7.5 mg/5mL; mg/5mL; mg/5mL Details
Polytussin DM 2; 15; 7.5 mg/5mL; mg/5mL; mg/5mL
Polytussin DM is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Poly Pharmaceuticals,. The primary component is DEXBROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE.
MedlinePlus Drug Summary
Brompheniramine relieves red, irritated, itchy, watery eyes; sneezing; and runny nose caused by allergies, hay fever, and the common cold. Brompheniramine helps control symptoms, but does not treat the cause of the symptoms or speed recovery. Brompheniramine should not be used to cause sleepiness in children. Brompheniramine 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: 50991-0121-16Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Brompheniramine
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: 50991-0121-16Last Updated: 11/30/2022
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: 50991-0121-16Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Phenylephrine
Product Information
| NDC | 50991-0121 |
|---|---|
| Product ID | 50991-121_cf4c931c-d9e1-8599-e053-2995a90a2623 |
| Associated GPIs | 43995803500930 |
| GCN Sequence Number | 076700 |
| GCN Sequence Number Description | d-methorphan/pe/dexbromphenir LIQUID 15-7.5-2/5 ORAL |
| HIC3 | B3R |
| HIC3 Description | NON-OPIOID ANTITUS-1ST GEN.ANTIHISTAMINE-DECONGEST |
| GCN | 42443 |
| HICL Sequence Number | 025559 |
| HICL Sequence Number Description | DEXTROMETHORPHAN HBR/PHENYLEPHRINE HCL/DEXBROMPHENIRAMINE |
| Brand/Generic | Brand |
| Proprietary Name | Polytussin DM |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Dexbrompheniramine Maleate, Dextromethorphan HBr, Phenylephrine HCl |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | LIQUID |
| Route | ORAL |
| Active Ingredient Strength | 2; 15; 7.5 |
| Active Ingredient Units | mg/5mL; mg/5mL; mg/5mL |
| Substance Name | DEXBROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE |
| Labeler Name | Poly Pharmaceuticals, |
| 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 | 2022-12-31 |
Package
Package Images
NDC 50991-0121-16 (50991012116)
| NDC Package Code | 50991-121-16 |
|---|---|
| Billing NDC | 50991012116 |
| Package | 473 mL in 1 BOTTLE (50991-121-16) |
| Marketing Start Date | 2021-10-20 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.04468 |
| Pricing Unit | ML |
| Effective Date | 2024-01-17 |
| NDC Description | POLYTUSSIN DM 2-15-7.5 MG/5 ML |
| 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 cf4c931c-d9e0-8599-e053-2995a90a2623 Details
Active Ingredient
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 toan 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
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
be careful when driving a motor vehicle or operating machinery
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 |
| 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. |
Inactive Ingredients
Questions? Comments?
INGREDIENTS AND APPEARANCE
| POLYTUSSIN DM
dexbrompheniramine maleate, dextromethorphan hbr, phenylephrine hcl liquid |
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| Labeler - Poly Pharmaceuticals, (198449894) |