TUSNEL PEDIATRIC DM- dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid 
Llorens Pharmaceutical International Division, Inc.

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.

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In each 5 mL

Dextromethorphan HBr - 5 mg

Guaifenesin - 75 mg

Phenylephrine HCl - 2.5 mg

Purpose

Cough Suppressant

Expectorant

Nasal Decongestant

Uses

Warnings

Do not use if your child is taking a 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 an MAOI, ask a doctor or pharmacist before giving this product.

Ask a doctor before use if your child has

Ask a doctor before use if your child is

Stop use and ask a doctor if your child gets

If pregnant or breast-feeding, ask a doctor before use

Keep out of reach of children. In case of accidental overdose, seek advice of a doctor or contact a Poison Control Center right away.

Directions: Do not exceed 6 doses in 24 hour

 Age Dose
Children 6 to under 12 years of age Take 2 teaspoonful (10 mL) every 4 hours
Children 2 to under 6 years of age  Take 1 teaspoonful (5 mL) every 4 hours
Children under 2 years of age Ask a doctor

Inactive ingredients: artificial and natural flavor, citric acid, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, and sucralose.

Questions or Comments? 1-866-595-5598

TusnelDMPED

TUSNEL PEDIATRIC  DM
dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54859-604
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN75 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE2.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54859-604-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/01/2019
Labeler - Llorens Pharmaceutical International Division, Inc. (037342305)
Registrant - Llorens Pharmaceutical International Division, Inc. (037342305)
Establishment
NameAddressID/FEIBusiness Operations
Llorens Pharmaceutical International Division, Inc.037342305manufacture(54859-604)

Revised: 6/2019
Document Id: 08481494-3a4d-4c21-963a-9d603f1abdff
Set id: 63541753-de8d-42fe-a9b3-a5eac3fcdca4
Version: 1
Effective Time: 20190609
 
Llorens Pharmaceutical International Division, Inc.