CHILDRENS COUGH AND COLD- childrens cough and cold 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.

----------

Children's Cough & Cold Liquid

Active Ingredient: Brompheniramine maleate 1 mg, Dextromethorphan HBr 5mg, Phenylephrine HCl 2.5 mg (in each 5 mL)

Purpose: Children's Cough & Cold

Cough & Cold

Warnings:

Do not use:

  • If you are now 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
  • To make a child sleep.

Ask a doctor before use if you have

  • Glaucoma
  • Thyroid disease
  • High blood pressure
  • Heart disease
  • Diabetes
  • Trouble urinating due to an enlarged prostate gland
  • Persistent or chronic cough such as occurs with smoking, asthma or emphysema
  • Cough that occurs with too much phlegm (mucus)
  • A breathing problem such as emphysema or chronic bronchitis

Ask a doctor or pharmacist before use if you are

  • Taking sedatives or tranquilizers

When using this product

Stop use and ask doctor if

A persistent cough may be a sign of a serious condition

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

If pregnant or breast-feeding, ask a health professional before use.

Directions:

Store between 20°C to 25°C (68° to 77° F)

anhydrous citric acid, artificial flavor, FD&C blue no. 1, FD&C red no. 40, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose

(packs: 4oz) Kingston NDC# 71027-047-04

Label
CHILDRENS COUGH AND COLD 
childrens cough and cold liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71027-047
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BROMPHENIRAMINE MALEATE (UNII: IXA7C9ZN03) (BROMPHENIRAMINE - UNII:H57G17P2FN) BROMPHENIRAMINE MALEATE1 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 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)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71027-047-041 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(71027-047)

Revised: 1/2019
Document Id: 42c1ef4e-8dfc-498f-a2ab-f724eb0f6c4a
Set id: df3e9800-72c8-4f3a-a25c-89971684ed99
Version: 2
Effective Time: 20190130
 
KINGSTON PHARMA LLC