Label: ULTRA TUSS DM - guaifenesin dextromethorphan hbr syrup
- NDC Code(s): 42213-161-93
- Packager: Ultra Seal Corporation
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated June 19, 2012
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- ACTIVE INGREDIENT
ctive Ingredients (In 5 ml) Guaifenesin 100 mg Dextromethorphann HBr 10 mg …Close
Purpose: Expectorant, Antitussive (Anti Cough)
- INDICATIONS & USAGE
• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passages of bothersome mucus,drain bronchial tubes, and make coughs more productive.
• restores free breathing
• suppresses cough due to minor throat and bronchial irritation associated with a cold or inhaled irritants
• A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor.
• Use more than the recommended dose.
• Give this product to a child who has heart disease, high blood pressure, thyroid disease, or diabetes unless directed by a doctor.
• Do not take this product, unless directed by a doctor, if you have a breathing problem such as emphysema or chronic bronchitis, or if you have glaucoma or difficulty in urination due to enlargement of the prostate gland.
• 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 MAOI drug. If you do not know if your prescription
drug contains an MAOI, consult a doctor or pharmacist before
taking this product
Stop use and ask a doctor if:
• symptoms do not improve
• new symptoms occur
• redness or swelling is present
• nervousness, dizziness or sleeplessness occur
• symptoms do not improve within 7 days or are accompanied by
• cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache.
Ask a doctor before use if you have:
• heart disease
• high blood pressure
• thyroid disease
• difficulty in urination due to enlargement of the prostate gland
• persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema or where cough is accompanied by excessive phlegm (mucus)
- PRINCIPAL DISPLAY PANEL
- KEEP OUT OF REACH OF CHILDREN
Keep out of reach of childrenClose
- DOSAGE & ADMINISTRATION
Adults and children 12 years of age and older
• Take 2 teaspoons (10 ml) every 4 hours as needed, do not exceed 12
teaspoons in 24 hours, or as directed by a doctor.
• Children 6-12 years, Take 1 teaspoon ( 5 ml) every 4 hours as needed, do not exceed 6 teaspoons in 24 hours, or as directed by a doctor.
• Children 2-6 years, Take 1/2 teaspoon ( 2.5 ml) every 4 hours as needed, do not exceed 3 teaspoons in 24 hours, or as directed by a doctor.
• Children under 2 years, consult a physician
- INACTIVE INGREDIENT
Inactive Ingredients: Citric Acid, FDC Red 40, Flavor, Glycerin, Methyl Paraben, Potassium Sorbate, Propyl Paraben, Propylene Glycol, Purified water, Sodium Citrate, Sodium SaccharinClose
- INGREDIENTS AND APPEARANCE
ULTRA TUSS DM
guaifenesin dextromethorphan hbr syrup
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42213-161 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 100 mg in 5 mL DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg in 5 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) GLYCERIN (UNII: PDC6A3C0OX) FD&C RED NO. 40 (UNII: WZB9127XOA) SODIUM CITRATE (UNII: 1Q73Q2JULR) SACCHARIN SODIUM ANHYDROUS (UNII: I4807BK602) PROPYLPARABEN (UNII: Z8IX2SC1OH) METHYLPARABEN (UNII: A2I8C7HI9T) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) Product Characteristics Color Score Shape Size Flavor CHERRY (sweet cherry) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42213-161-93 474 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 06/19/2012 Labeler - Ultra Seal Corporation (085752004) Registrant - Ultra Seal Corporation (085752004) Establishment Name Address ID/FEI Business Operations ULTRAtab Laboratories, Inc. 151051757 manufacture