Label: TUSSLIN PEDIATRIC- dextromethorphan hbr, guiafenesin, phenylephrine hcl solution/ drops
- NDC Code(s): 52083-623-01
- Packager: Kramer Novis
- 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 September 16, 2019
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- ACTIVE INGREDIENT
Do not use
in child who 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 contains a MAOI, ask a doctor or pharmacist before giving this product.
DO NOT USE
Ask a doctor before use if your child has
- heart disease
- thyroid disease
- high blood pressure
- a cough that occurs with too much phlegm (mucus)
- cough that lasts or is chronic such as occurs with asthma
When using this product do not exceed recommended dosage
Stop use and ask a doctor if
- new symptoms occur
- your child gets nervous, dizzy or sleepless
- symptoms do not get better within 7 days or are accompanied by fever
- cough last more than 7 days, comes back, or is accompanied by fever, rash or persistent headache. These could be a signs of a serious condition.
- heart disease
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
DOSAGE & ADMINISTRATION
do not use more than 4 doses in any 24-hour period
Children 6 to under 12 years of age
- 2 mL every 6 hours, do not exceed 4 doses.
Children 2 to under 6 years of age
- 1 mL every 6 hours, do not exceed 4 doses, or as directed by a doctor.
Children under 2, consult a doctor
- measure with the dosage device provided. Do not use any other device.
- INDICATIONS & USAGE
- INACTIVE INGREDIENT
- Principal Display Panel
INGREDIENTS AND APPEARANCE
dextromethorphan hbr, guiafenesin, phenylephrine hcl solution/ drops
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52083-623 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 7.5 mg in 1 mL GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 88 mg in 1 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 2.5 mg in 1 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) METHYLPARABEN (UNII: A2I8C7HI9T) AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52083-623-01 30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 01/27/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 01/27/2014 Labeler - Kramer Novis (090158395)