NDC | 52083-623-01 |
Set ID | 6fe91407-08c1-465b-9c00-251c94b1f7f0 |
Category | HUMAN OTC DRUG LABEL |
Packager | Kramer Novis |
Generic Name | |
Product Class | alpha-1 Adrenergic Agonist |
Product Number | |
Application Number | PART341 |
- ACTIVE INGREDIENT
- PURPOSE
-
WARNINGS
Warnings
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
- diabetes
- 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
Directionsdo 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
- QUESTIONS
- Principal Display Panel
-
INGREDIENTS AND APPEARANCE
TUSSLIN PEDIATRIC
dextromethorphan hbr, guiafenesin, phenylephrine hcl solution/ dropsProduct 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)