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Aquanaz

Medically reviewed on Jun 25, 2018

Dosage form: tablet
Ingredients: DEXTROMETHORPHAN HYDROBROMIDE 15mg, GUAIFENESIN 400mg, PHENYLEPHRINE HYDROCHLORIDE 10mg
Labeler: Capital Pharmaceutical, LLC
NDC Code: 29978-587

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.

Aquanaz Tablets

Aquanaz Drug Facts.

Active Ingredient.

Dextromethorphan HBr 15mg.

Purpose.

Cough Suppressant.

Active Ingredient.

Guaifenesin 400mg.

Purpose.

Expectorant.

Active Ingredient.

Phenylephrine HCL 10mg.

Purpose.

Nasal Decongestant.

Uses:

Temporally relieves these symptoms accruing with a cold nasal decongestion cough due to minor throat and bronchial irritation—helps loosen phlegm (mucus) and thins bronchial secretions to drain bronchial tubes.

Warnings: When using this product do not exceed recommended dose.

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 MAOI drugs. If you do not know if your prescription drug contains an MAOI. Consult a doctor or pharmacist before taking this product.

Stop use and ask a doctor if:

Symptoms do not improve--new symptoms occur--redness or swelling is present--nervousness, dizziness or sleeplessness occurs--symptoms do not improve within 7 days or are accompanied by fever--cough persists for more than 1 week, tends to recur, or is a accompanied by fever, rash or persistent headache. A persistent cough may be the sign of a serious condition.

Ask a doctor before use if you have:

Heart disease--high blood pressure--thyroid disease—diabetes--difficulty in urination 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 (mucus)

Directions:

Adults and children 12 years and older: Take 1tablet every 4-6 hours as needed, do not exceed 4 tablets in 24hours, or as directed by a doctor.

Children 6-12 years: Take ½ tablet every 4-6 hours as needed, do not exceed 2 tablets in 24 hours, or as directed by a doctor.

If pregnant or breast-feeding baby,

ask a health care 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:

F&C Blue #2 Microcrystalline Celulose, Silicone Dioxide, Stearic Acid.

Other Information:

Do not use if there are signs of tampering—Store at controlled room temperature 15deg-30degC (59-86degF)

PRINCIPAL DISPLAY PANEL

NDC 29978-587-01
NEW

Aquanaz
TABLETS

TRIPLE COMBINATION RELIEF:

Cough Suppressant: Dextromethorphan HBR 15 MG
Expectorant: Guaifenesin 400 MG
Decongestant: Phenylephrine HCL 10 MG
100 Tablets

AQUANAZ 
dextromethorphan hydrobromide, guaifenesin and phenylephrine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29978-587
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE15 mg
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN400 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 2 
CELLULOSE, MICROCRYSTALLINE 
SILICON DIOXIDE 
STEARIC ACID 
Product Characteristics
ColorBLUE (light blue) Scoreno score
ShapeOVALSize15mm
FlavorImprint CodePAC3
Contains    
Packaging
#Item CodePackage Description
1NDC:29978-587-01100 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34103/10/2015
Labeler - Capital Pharmaceutical, LLC (831545541)

 
Capital Pharmaceutical, LLC

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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