NOVALGINA CHILDREN COUGH AND COLD- acetaminofen, dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid 
All 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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Novalgina Children Cough and Cold

Active Ingredients:(in each 10 ml.)Purpose

Acetaminophen 250 mg ........................................................

Analgesic

Dextromethorphan Hydrobromide 13.33 mg .......................

Cough Suppressant

Guaifenesin USP 200 mg......................................................

Expectorant

Phenylephrine HCl 5 mg.......................................................

Decongestant

Uses:

Warnings

Do not exceed recommended dosage


Liver Warning this product contatins Acetaminophen. Severe liver damage may occur if



Stop use and ask a doctor

Ask doctor before use if you have

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


Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions


AGE
DOSE
Adults and Children 12 years and over
10 ml (2 tsps) every 6 hours
Children 6 to under 12 years of age
5 ml (1 tsp) every 6 hours
Children under 6 years of age
Do not  use



Other Information:

Inactive Ingredient

Aloe Vera, Citric Acid, Disodium EDTA, FDC Red #40, Hydroxyethyl Cellulose, Natural Strawberry Flavor, Propylene Glycol USP, Purified Water, Sodium Benzoate, Sorbitol 70% USP, Sucralose.

Questions or Comments

Call Weekdays from 9:30 AM to 5PM EST at Tel 800-491-7908

Made in U.S.A.

Children Cough and Cold Label

NOVALGINA  CHILDREN COUGH AND COLD
acetaminofen, dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53149-2002
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN250 mg  in 10 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE13.33 mg  in 10 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg  in 10 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53149-2002-61 in 1 CARTON01/01/2015
1177 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/01/2001
Labeler - All Pharma LLC (117605075)
Registrant - All Pharma LLC (117605075)
Establishment
NameAddressID/FEIBusiness Operations
All Pharma LLC117605075MANUFACTURE(53149-2002)

Revised: 1/2020
Document Id: f959e3f4-4c31-42af-9974-2fbfc3199372
Set id: dcb06698-a546-4595-9cd0-26fd96a9be89
Version: 2
Effective Time: 20200101
 
All Pharma LLC