NOVALGINA CHILDREN COUGH AND COLD- acetaminofen, dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid 
HBC Pharma, LLC

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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:83057-0001
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
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)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83057-0001-61 in 1 CARTON11/01/2022
1180 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01211/01/2022
Labeler - HBC Pharma, LLC (063580631)
Establishment
NameAddressID/FEIBusiness Operations
GADAL Laboratories, Inc841305639manufacture(83057-0001)

Revised: 11/2024
Document Id: 2618f02b-442e-afe3-e063-6394a90adc6f
Set id: eb3f0cb2-03d4-1776-e053-2a95a90acf37
Version: 4
Effective Time: 20241104
 
HBC Pharma, LLC