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Atuss Ds Tannate Suspension Recall
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Questions & Answers
Side Effects & Adverse Reactions
Do not take this product for persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or where cough is accompanied by excessive phlegm (mucus) unless directed by a doctor. Sympathomimetic amines should be used with caution in patients with hypertension, ischemic heart disease, diabetes mellitus, increased intraocular pressure, hyperthyroidism, or prostatic hypertrophy. Sympathomimetics may produce central nervous system stimulation with convulsions or cardiovascular collapse with accompanying hypotension. Nervousness, dizziness or sleeplessness may occur at higher doses.
Hypertensive crises can occur with concurrent use of pseudoephedrine and MAOI, indomethacin, or with beta blockers and methyldopa. If a hypertensive crisis occurs, these drugs should be discontinued immediately and therapy to lower blood pressure should be instituted. Fever should be managed by means of external cooling. Do not exceed recommended dosage.
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Atuss® DS Tannate Suspension is indicated for temporary relief of nasal congestion and cough associated with respiratory tract infections and related conditions such as sinusitis, pharyngitis, bronchitis and asthma when these conditions are complicated by tenacious mucus and/or mucous plugs and congestion. Atuss® DS Tannate Suspension is effective in a productive as well as a nonproductive cough, but is of particular value in a dry nonproductive cough which tends to injure the mucous membrane of the air passages.
History
There is currently no drug history available for this drug.
Other Information
Each teaspoonful (5 mL) of Atuss® DS Tannate Suspension contains:
Dextromethorphan Hydrobromide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30 mg
Pseudoephedrine Hydrochloride . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30 mg
Chlorpheniramine Maleate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 mg
Atuss® DS Tannate Suspension is used for oral administration only.
Atuss® DS Tannate Suspension contains the following inactive ingredients: Acesulfame K, Artificial Bubblegum Flavor, Artificial Grape Flavor, Aspartame, Bitter Mask, Citric Acid, FDC Blue #1, FDC Red #40, Glycerin, Hydrochloric Acid, Methylparaben, Magnesium Aluminometasilicate, Purified Water, Sodium Citrate Dihydrate, Sodium Hydroxide, Sucralose, Xanthan Gum. Plus tannic acid yielding a tannate suspension.
Dextromethorphan Hydrobromide:
3-Methoxy-17-methyl-9α, 13α, 14α-morphinan.
Pseudoephedrine Hydrochloride:
[S(R*, R*)]- α -[1-(methylamino)ethyl] benzenemethanol hydrochloride.
Chlorpheniramine Maleate:
2-[p-chloro- α -[2-(dimethylamino) ethyl]-benzyl] pyridine.
Sources
Atuss Ds Tannate Suspension Manufacturers
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Atley Pharmaceuticals, Inc.
Atuss Ds Tannate Suspension | Atley Pharmaceuticals, Inc.
Adults and children over age 12: 1–2 teaspoonsful every 12 hours. Children ages 6 to 12: 1/2 – 1 teaspoonful every 12 hours. Children ages 2 to 6: 1/2 teaspoonful every 12 hours. Children under age 2: As directed by a physician.
Shake well before use.
Note: The hydrobromide salt of dextromethorphan, the hydrochloride salt of pseudoephedrine, and the maleate salt of chlorpheniramine are provided in a tannate suspension by means of the TCT manufacturing process. This yields a corresponding 60 mg of dextromethorphan tannate, 60 mg of pseudoephedrine tannate, and 8 mg of chlorpheniramine tannate.
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