Label: ALTIDESP- dextromethorphan hbr, guaifenesin, phenylephrine hcl solution/ drops
- NDC Code(s): 53163-108-01
- Packager: Alternative Pharmacal Corporation
- Category: HUMAN OTC DRUG LABEL
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 December 23, 2020
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- ACTIVE INGREDIENT
INDICATIONS & USAGE
- helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
- temporarily relieves nasal congestion due to hay fever or other upper respiratory allergies (allergic rhinitis) and cough due to minor throat and bronchial irritation as may occur with the common cold.
Do not exceed recommended dosage
If nervousness, dizziness, or sleeplessness occurs, discontinue use and consult a doctor. If symptoms do not improve within 7 days or are accompanied by fever, consult a doctor.
Do not use this product: for persistent or chrnoic cough such as occurs with asthma, or if cough is accompanied by excessive phlegm (mucus), unless directed by a doctor.
In a chlid who is taking a prescription Monoaminooxidase Inhibito (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for two weeks after stopping the MAOI drug; If you do not know if your child's prescription drug contains an MAOI, ask a doctor or phamacist before giving this product.
Do not give this product to a child who has heart disease, high blood pressure, thyroid disease, or diabetes, unless directed by a doctor.
Stop use and ask a doctor before use if:
- A persistent cough may be a sign of a serious condition
- If cough persists for more than one week, tend to recur, or is accompanied by fever, rash or persistent heachache, consult a doctor.
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
dextromethorphan hbr, guaifenesin, phenylephrine hcl solution/ drops
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53163-108 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 5 mg in 1 mL GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 50 mg in 1 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 2.5 mg in 1 mL Inactive Ingredients Ingredient Name Strength SACCHARIN CALCIUM (UNII: 5101OP7P2I) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) GLYCERIN (UNII: PDC6A3C0OX) METHYLPARABEN (UNII: A2I8C7HI9T) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) SODIUM CITRATE (UNII: 1Q73Q2JULR) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53163-108-01 30 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/01/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 03/01/2015 Labeler - Alternative Pharmacal Corporation (078528214)