Indications and uses
Temporarily relieves these symptoms occurring with a cold nasal decongestion: ▪ cough due to minor throat and bronchial irritation ▪ helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes.
Aquanaz
- Manufacturer
- Capital Pharmaceutical, LLC
- Effective date
- 2020-08-21
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 23:16:36
Label at a glance#
ProductAquanaz PSE
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE
Label structure12 sections
Dosage and administration
Adults and children 12 years of age and over 1 tablet every 4 hours, not to exceed 4 tablets in 24 hours, or as directed by a doctor. Children 6 to under 12 years of age 1/2 tablet every 4 hours, not to exceed 2 tablets in 24 hours, or as directed by a doctor. Do not exceed recommended dosage.
Contacts and useful links#
Label contents#
Full prescribing information#
Active Ingredients
Dextromethorphan HBr 20mg
Guaifenesin 375mg
Pseudoephedrine HCl 60mg
Purpose
Cough Suppressant
Expectorant
Nasal Decongestant
Uses
Temporarily relieves these symptoms occurring with a cold nasal decongestion:
▪ cough due to minor throat and bronchial irritation
▪ helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes.
Warnings
▪ When using this product do not exceed recommended dosage.
- 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.
Stop use and ask doctor if
▪ symptoms do not improve
▪ new symptoms occur
▪ redness or swelling is present
▪ nervousness, dizziness, or sleeplessness occur
▪ symptoms do not improve within 7 days or are accompanied by fever
▪ cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or
persistent headache. A persistent cough may be a sign of a serious condition.
Ask Doctor before use if you have
▪ heart disease
▪ high blood pressure
▪ thyroid disease
▪ diabetes
▪ difficulty in urinating due to enlargement of the prostate gland
▪ persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or
emphysema or where cough is accompanied by excessive phlegm
Directions
| Adults and children 12 years of age
and over | 1 tablet every 4 hours, not to
exceed 4 tablets in 24 hours, or as directed by a doctor. |
Children 6 to under 12 years of age | 1/2 tablet every 4 hours, not to
exceed 2 tablets in 24 hours, or as directed by a doctor. |
Do not exceed recommended dosage.
Pregnant or Breast Feeding
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. Prompt
medical attention is critical for adults as well as children even if you do not notice any signs or
symptoms
Inactive Ingredients
Carnauba Wax, FD&C Blue #1 Aluminum Lake, FD&C Yellow #5 Aluminum Lake, Magnesium
Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polysorbate 80, Polyvinyl Alcohol,
Silicon Dioxide, Talc
Other information
Store at 15°-30°C (59°-86°F).
- Aquanaz PSE is a clear coated caplet with green core, debossed with “AQ” Bisection “PSE” on
one side and smooth on the other side.
- Contains color additives including FD&C Yellow No. 5 (tartrazine).
- Supplied in a tight, light-resistant container with a child-resistant cap.
- Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing.
- Store at Controlled Room Temperature 15°-30°C (59°-86°F).
Questions? Comments
Call 1(614) 638-4622
Package Label
NDC 29978-588-90
Aquanaz PSE Tablets
Triple Combination Relief:
Cough Suppressant: Dextromethorphan HBr 20 mg
Expectorant: Guaifenesin 375 mg
Nasal Decongestant: Pseudoephedrine HCI 60 mg
90 tablets
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 29978-588-90 | EA - Each | 29978-588 | fde4a999-369e-4924-9aea-d0e7072b1e61 | 1 | 2021-01-08 |
Products#
Every source-derived product name is available through these pages.
- Aquanaz PSE
- Dextromethorphan HBr, Guafenesin, Pseudoephedrine HCl
- POLYSORBATE 80
- FD&C BLUE NO. 1
- TALC
- SODIUM STARCH GLYCOLATE TYPE A CORN
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- GUAIFENESIN
- FD&C YELLOW NO. 5
- MAGNESIUM STEARATE
- PSEUDOEPHEDRINE HYDROCHLORIDE
- PSEUDOEPHEDRINE
- POLYETHYLENE GLYCOL, UNSPECIFIED
- POLYVINYL ALCOHOL, UNSPECIFIED
- SILICON DIOXIDE
- MICROCRYSTALLINE CELLULOSE
- CARNAUBA WAX
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 29978-588 | 29978-588-90 |
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 |
|---|---|---|---|---|---|---|
| 0dfa2992-cb91-c26b-e063-6394a90ae96d | a50074cd-d830-ca26-e053-2a95a90a6bc9 | 2024-01-02 | Warnings | a50074cd-d830-ca26-e053-2a95a90a6bc9 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.