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

Novalgina by

Drug Labeling and Warnings

Novalgina by is a Otc medication manufactured, distributed, or labeled by HBC Pharma, LLC, GADAL Laboratories, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

• 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

PURPOSE

Uses:

• For temporary relief og Bronchial and Nasal congestion
• Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make cough more productive.
• Temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold.

WARNINGS

Warnings

Do not exceed recommended dosage

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

DO NOT USE

• Adult takes more than 6 doses in 24 hours, which is the maximum daily amount
• Child takes more than 5 doses in 24 hours
• Taken with other drugs containing Acetaminophen.
• Adult has 3 or more alcoholic drinks every day while using this product
• Do not give to children under 3 years of age or use for more than 10 days unless directed by a physician
• Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric conditions, or Parkinson's disease) or for 2 weeks after stopping MAOI drug.
• If you do not know if your prescription drug contains MAOI as your doctor or pharmacist before taking this product.
• If you have a chronic pulmonary disease or shortness of breath unless directed by a doctor.
• Avoid alcoholic beverage while taking this product.
• Do not use with any other drug containing Acetaminophen (prescription no nonprescription) If you are not sure whether a drug contains Acetaminophen, ask a doctor or pharmacist

Stop use and ask a doctor

• Nervousness, dizziness or sleeplessness occurs.
• Cough persists more than 1 week, tends to recur or is accompanied by a fever, rash or persistent headache. A persistent cough may be signserious condition.

ASK DOCTOR

Ask doctor before use if you have

• Cough that occurs with too much phlegm(mucus)
• Cough that last or is a chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema.
• Heart disease, high blood pressure, thyroid disease, or difficulty in urination due enlargement of prostate gland.
• The user has Liver diseases
• The user us taking the blood thinning drug Warfarin

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

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

DOSAGE & ADMINISTRATION

Directions

• Do not exceed 6 doses in any 24-hour period.

• 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

INDICATIONS & USAGE

Other Information:

• Each 10 mls contains: sodium 4 mg
• Store between 15 - 30 degrees Celsius (59 - 86 Fahrenheit).
• Tamper Evident Feature:Do not use if seal under cap is torn, broken or missing.

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

NOVALGINA  CHILDREN COUGH AND COLD
acetaminofen, dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83057-0001
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	250 mg  in 10 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	13.33 mg  in 10 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg  in 10 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83057-0001-6	1 in 1 CARTON	11/01/2022
1		180 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	11/01/2022

Labeler - HBC Pharma, LLC (063580631)

Establishment
Name	Address	ID/FEI	Business Operations
GADAL Laboratories, Inc		841305639	manufacture(83057-0001)