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NDC 52083-0623-01 Tusslin 7.5; 88; 2.5 mg/mL; mg/mL; mg/mL Details
Tusslin 7.5; 88; 2.5 mg/mL; mg/mL; mg/mL
Tusslin is a ORAL SOLUTION/ DROPS in the HUMAN OTC DRUG category. It is labeled and distributed by Kramer Novis. The primary component is DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE.
Product Information
NDC | 52083-0623 |
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Product ID | 52083-623_a5539e41-632f-4d48-8a49-1d93e5c531be |
Associated GPIs | 43997303100945 |
GCN Sequence Number | 065717 |
GCN Sequence Number Description | guaifen/dextromethorphan/PE LIQUID 7.5-2.5/ML ORAL |
HIC3 | B4R |
HIC3 Description | NON-OPIOID ANTITUSSIVE-DECONGESTANT-EXPECTORANT |
GCN | 27748 |
HICL Sequence Number | 000216 |
HICL Sequence Number Description | GUAIFENESIN/DEXTROMETHORPHAN HBR/PHENYLEPHRINE |
Brand/Generic | Generic |
Proprietary Name | Tusslin |
Proprietary Name Suffix | Pediatric |
Non-Proprietary Name | Dextromethorphan Hbr, Guiafenesin, Phenylephrine HCl |
Product Type | HUMAN OTC DRUG |
Dosage Form | SOLUTION/ DROPS |
Route | ORAL |
Active Ingredient Strength | 7.5; 88; 2.5 |
Active Ingredient Units | mg/mL; mg/mL; mg/mL |
Substance Name | DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE |
Labeler Name | Kramer Novis |
Pharmaceutical Class | Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC] |
DEA Schedule | n/a |
Marketing Category | OTC MONOGRAPH FINAL |
Application Number | part341 |
Listing Certified Through | 2024-12-31 |
Package
Package Images

NDC 52083-0623-01 (52083062301)
NDC Package Code | 52083-623-01 |
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Billing NDC | 52083062301 |
Package | 30 mL in 1 BOTTLE, DROPPER (52083-623-01) |
Marketing Start Date | 2014-01-27 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 6fe91407-08c1-465b-9c00-251c94b1f7f0 Details
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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.
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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.
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Directions
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.
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Principal Display Panel
INGREDIENTS AND APPEARANCE
TUSSLIN
PEDIATRIC
dextromethorphan hbr, guiafenesin, phenylephrine hcl solution/ drops |
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Labeler - Kramer Novis (090158395) |
Revised: 9/2019
Document Id: a5539e41-632f-4d48-8a49-1d93e5c531be
Set id: 6fe91407-08c1-465b-9c00-251c94b1f7f0
Version: 3
Effective Time: 20190916