Novalgina
- Manufacturer
- HBC Pharma, LLC | GADAL Laboratories, Inc
- Effective date
- 2024-11-04
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- full-release
- Hydrated at
- 2026-06-01 00:34:01
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
| 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 |
OTC - PURPOSE SECTION
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 SECTION
Warnings
Do not exceed recommended dosage
Liver Warning this product contatins Acetaminophen. Severe liver damage may occur if
OTC - DO NOT USE SECTION
- 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.
OTC - ASK DOCTOR SECTION
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
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.
DOSAGE & ADMINISTRATION SECTION
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 SECTION
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.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1790651 | acetaminophen 250 MG / dextromethorphan HBr 13.33 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG in 10 mL Oral Solution | PSN | 4 |
| 1790651 | acetaminophen 25 MG/ML / dextromethorphan hydrobromide 1.33 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution | SCD | 4 |
| 1790651 | acetaminophen 250 MG / dextromethorphan HBr 13.33 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG per 10 ML Oral Solution | SY | 4 |
| 1790651 | acetaminophen 500 MG / dextromethorphan HBr 26.66 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 20 ML Oral Solution | SY | 4 |
| 1790651 | APAP 25 MG/ML / Dextromethorphan Hydrobromide 1.33 MG/ML / Guaifenesin 20 MG/ML / Phenylephrine Hydrochloride 0.5 MG/ML Oral Solution | SY | 4 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| GUAIFENESIN Pharmacologic Class Indexing | 1 | Indexing - Pharmacologic Class | 20211129 |
| PHENYLEPHRINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 83057-0001-6 | NovalginaChildren Cough and Cold | 180 mL in 1 BOTTLE | LIQUID | 180 | 4 | |
| 83057-0001-6 | NovalginaChildren Cough and Cold | 1 in 1 CARTON | LIQUID | 1 | 4 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 83057-0001 | NOVALGINA CHILDREN COUGH AND COLD (ACETAMINOFEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [HBC PHARMA, LLC] | 4 | Legacy NDC, 2 package rows | 20241105_eb3f0cb2-03d4-1776-e053-2a95a90acf37.zip |
Products#
Every source-derived product name is available through these pages.
- Novalgina Children Cough and Cold
- Acetaminofen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
- CITRIC ACID MONOHYDRATE
- EDETATE DISODIUM
- FD&C RED NO. 40
- HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)
- PROPYLENE GLYCOL
- WATER
- SODIUM BENZOATE
- SORBITOL
- SUCRALOSE
- ACETAMINOPHEN
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- GUAIFENESIN
- ALOE VERA LEAF
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 83057-0001 | 83057-0001-6 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 2618f02b-442e-afe3-e063-6394a90adc6f | eb3f0cb2-03d4-1776-e053-2a95a90acf37 | 2024-11-04 | Warnings | 2618f02b-442e-afe3-e063-6394a90adc6f eb3f0cb2-03d4-1776-e053-2a95a90acf37 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
