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NDC 36800-0788-26 topcare tussin dm max 30; 12.5 mg/20mL; mg/20mL Details
topcare tussin dm max 30; 12.5 mg/20mL; mg/20mL
topcare tussin dm max is a ORAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Topco Associates LLC. The primary component is DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE.
MedlinePlus Drug Summary
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: 36800-0788-26Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Dextromethorphan
Doxylamine is used in the short-term treatment of insomnia (difficulty falling asleep or staying asleep). Doxylamine is also used in combination with decongestants and other medications to relieve sneezing, runny nose, and nasal congestion caused by the common cold. Doxylamine should not be used to cause sleepiness in children. Doxylamine 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: 36800-0788-26Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Doxylamine
Product Information
| NDC | 36800-0788 |
|---|---|
| Product ID | 36800-788_a6916be3-2cde-4de8-b03d-e8b2c80d4fe5 |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | topcare tussin dm max |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Dextromethorphan hydrobromide, Doxylamine succinate |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SOLUTION |
| Route | ORAL |
| Active Ingredient Strength | 30; 12.5 |
| Active Ingredient Units | mg/20mL; mg/20mL |
| Substance Name | DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE |
| Labeler Name | Topco Associates LLC |
| Pharmaceutical Class | Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 36800-0788-26 (36800078826)
| NDC Package Code | 36800-788-26 |
|---|---|
| Billing NDC | 36800078826 |
| Package | 1 BOTTLE in 1 CARTON (36800-788-26) / 118 mL in 1 BOTTLE |
| Marketing Start Date | 2019-05-02 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL e1118592-30ac-4505-9f38-c6d395c4cf5b Details
Uses
- •
- temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
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- temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- •
- runny nose
- •
- sneezing
- •
- itchy, watery eyes
- •
- itching of the nose or throat
- •
- controls the impulse to cough to help you sleep
Warnings
Do not use
- •
- to make a child sleepy
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- 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
- •
- trouble urinating due to an enlarged prostate gland
- •
- glaucoma
- •
- cough that occurs with too much phlegm (mucus)
- •
- a breathing problem such as emphysema or chronic bronchitis
- •
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
When using this product
- •
- do not use more than directed
- •
- marked drowsiness may occur
- •
- avoid alcoholic drinks
- •
- alcohol, sedatives, and tranquilizers may increase drowsiness
- •
- be careful when driving a motor vehicle or operating machinery
- •
- excitability may occur, especially in children
Directions
- •
- measure only with dosing cup provided
- •
- keep dosing cup with product
- •
- mL = milliliter
- •
- do not take more than 4 doses in any 24-hour period
- •
- this adult product is not intended for use in children under 12 years of age
|
age |
dose |
|
adults and children 12 years and over |
20 mL every 6 hours |
|
children under 12 years |
do not use |
Inactive ingredients
Principal Display Panel
TopCare® health
COMPARE TO ROBITUSSIN® MAXIMUM STRENGTH NIGHTTIME COUGH DM ACTIVE INGREDIENTS
NIGHTTIME
Tussin DM Max
Nighttime Cough DM
COUGH SUPPRESSANT – DEXTROMETHORPHAN HBr
ANTIHISTAMINE – DOXYLAMINE SUCCINATE
MAXIMUM STRENGTH
RELIEVES:
• Cough
• Itchy Throat
• Runny Nose
Adult For Ages 12 & Over
4 FL OZ (118 mL)
RASPBERRY, BLACKBERRY & MENTHOL FLAVOR
INGREDIENTS AND APPEARANCE
| TOPCARE TUSSIN DM MAX
dextromethorphan hydrobromide, doxylamine succinate solution |
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| Labeler - Topco Associates LLC (006935977) |