AQUANAZ- dextromethorphan hydrobromide, guaifenesin and phenylephrine hydrochloride tablet

Aquanaz by

Drug Labeling and Warnings

Aquanaz by is a Otc medication manufactured, distributed, or labeled by Capital Pharmaceutical, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

AQUANAZ 
dextromethorphan hydrobromide, guaifenesin and phenylephrine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 29978-587
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	15 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	400 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	blue (light blue)	Score	no score
Shape	OVAL	Size	15mm
Flavor		Imprint Code	PAC3
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 29978-587-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	03/10/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	03/10/2015

Labeler - Capital Pharmaceutical, LLC (831545541)