Active Ingredient.
Dextromethorphan HBr 15mg.
Guaifenesin 400mg.
Phenylephrine HCL 10mg.
Aquanaz Tablet
FDA Label NDC 29978-587
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Capital Pharmaceutical, Llc for the product Aquanaz (NDC 29978-587). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient., purpose., uses:, warnings: when using this product do not exceed recommended dose., stop use and ask a doctor if:, ask a doctor before use if you have:, directions:, if pregnant or breast-feeding baby,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose.
Cough Suppressant.
Expectorant.
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
Principal Display Panelndc 29978-587-01newaquanaztabletstriple Combination Relief:cough Suppressant: Dextromethorphan Hbr 15 mgexpectorant: Guaifenesin 400 mgdecongestant: Phenylephrine HCl 10 mg100 Tablets (Aquanaz Tablets 01)
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