Label: ALTICOTRON- dextromethorphan hbr, guaifenesin, phenylephrine hcl solution/ drops
- NDC Code(s): 53163-107-02
- Packager: Alternative Pharmacal 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 December 23, 2020
If you are a consumer or patient please visit this version.
- ACTIVE INGREDIENT
INDICATIONS & USAGE
- non-narcotic cough suppreassant which temporarily calms due to minor throat and bronchial irritation as may occur with common cold
- helps decongest sinus openings and passages; temporarily relieves sinus openings and passages; temporarily relieves sinus congestion and pressur
- helps lossen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
- temporarily relieves nasal congestion due to the common cold
- helps decongest sinus openings and passages; temporarily relieves sinus congestion and pressure
a persistant cough may be 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.
DO NOT USE
If a child is 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 child's prescription drug that contains MAOI; ask your doctor or pharmacist before taking this product.
Ask a doctor before use if the child has:
- Heart disease
- High blood pressure
- Thyroid deases
- Cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or where cough is accompanied by excessive phlegm (mucus)
When using this product do not exceed recommended dosage.
Stop use and ask a doctor before use if:
- your child gets nervous, dizzy, or sleepless
- symptoms do not get better within 7 days or are accompanied by fever
- cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
- 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:53163-107 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 100 mg in 1 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 2.5 mg in 1 mL Inactive Ingredients Ingredient Name Strength 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) SUCRALOSE (UNII: 96K6UQ3ZD4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53163-107-02 60 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)