CHILDRENS TUSSIN DM- childrens tussin dm liquid 
KINGSTON PHARMA LLC

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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Children’s Tussin DM

Active Ingredient: Active Ingredient: Dextromethorphan HBr 5mg, Guaifenesin 100mg (in each 5 mL)

Purpose:
Cough suppressant
Expectorant

DO NOT USE IF PRINTED SEAL OVER IS TORN OR MISSING

Warnings:

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

Ask a doctor before use if the child has

  • Cough that occurs with too much phlegm (mucus)
  • Persistent or chronic cough such as occurs with asthma

Stop use and ask doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.

Keep this and all drugs out of the reach of children. In case of overdose, seek professional assistance or contact a Poison control center right away.

Directions:

Other information

Inactive ingredients
Anhydrous citric acid, Artificial & Natural flavors, FD&C Blue#1, FD&C red 40, Sucralose, Glycerin, Polyethylen Glycol, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Benzoate

(packs: 4oz) Kingston NDC# 71027-036-04

Manufactured by: Kingston Pharma LLC
5 County Route 42
Massena, NY 13662

Label
CHILDRENS TUSSIN DM 
childrens tussin dm liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71027-032
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) GUAIFENESIN100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71027-032-041 in 1 CARTON03/01/2017
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/01/2017
Labeler - KINGSTON PHARMA LLC (080386521)
Registrant - KINGSTON PHARMA LLC (080386521)
Establishment
NameAddressID/FEIBusiness Operations
KINGSTON PHARMA LLC080386521manufacture(71027-032)

Revised: 3/2017
Document Id: 79bd8e8f-7f05-4de4-8bbb-4b379df78957
Set id: 79bd8e8f-7f05-4de4-8bbb-4b379df78957
Version: 1
Effective Time: 20170301
 
KINGSTON PHARMA LLC