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NDC 29978-0587-01 Aquanaz 15; 400; 10 mg/1; mg/1; mg/1 Details

Aquanaz 15; 400; 10 mg/1; mg/1; mg/1

Aquanaz is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Capital Pharmaceutical, LLC. The primary component is DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE.

MedlinePlus Drug Summary

Dextromethorphan is used to temporarily relieve cough caused by the common cold, the flu, or other conditions. Dextromethorphan will relieve a cough but will not treat the cause of the cough or speed recovery. Dextromethorphan is in a class of medications called antitussives. It works by decreasing activity in the part of the brain that causes coughing.

Related Packages: 29978-0587-01
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Dextromethorphan

Guaifenesin is used to relieve chest congestion. Guaifenesin may help control symptoms but does not treat the cause of symptoms or speed recovery. Guaifenesin is in a class of medications called expectorants. It works by thinning the mucus in the air passages to make it easier to cough up the mucus and clear the airways.

Related Packages: 29978-0587-01
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Guaifenesin

Phenylephrine is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Phenylephrine will relieve symptoms but will not treat the cause of the symptoms or speed recovery. Phenylephrine is in a class of medications called nasal decongestants. It works by reducing swelling of the blood vessels in the nasal passages.

Related Packages: 29978-0587-01
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Phenylephrine

Product Information

NDC	29978-0587
Product ID	29978-587_a0acddf1-a97e-bf37-e053-2995a90a0bd5
Associated GPIs	43997303100314
GCN Sequence Number	072784
GCN Sequence Number Description	guaifen/dextromethorphan/PE TABLET 400-15-10 ORAL
HIC3	B4R
HIC3 Description	NON-OPIOID ANTITUSSIVE-DECONGESTANT-EXPECTORANT
GCN	37072
HICL Sequence Number	000216
HICL Sequence Number Description	GUAIFENESIN/DEXTROMETHORPHAN HBR/PHENYLEPHRINE
Brand/Generic	Brand
Proprietary Name	Aquanaz
Proprietary Name Suffix	n/a
Non-Proprietary Name	Dextromethorphan Hydrobromide, Guaifenesin and Phenylephrine Hydrochloride
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	15; 400; 10
Active Ingredient Units	mg/1; mg/1; mg/1
Substance Name	DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Labeler Name	Capital Pharmaceutical, LLC
Pharmaceutical Class	Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part341
Listing Certified Through	2022-12-31

Package

Package Images

NDC 29978-0587-01 (29978058701)

Pricing Information	N/A
NDC Package Code	29978-587-01
Billing NDC	29978058701
Package	100 TABLET in 1 BOTTLE (29978-587-01)
Marketing Start Date	2015-03-10
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 5e9e4dfd-4def-4756-9bba-d25068640101 Details

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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

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

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

Labeler - Capital Pharmaceutical, LLC (831545541)

Revised: 3/2020

Document Id: a0acddf1-a97e-bf37-e053-2995a90a0bd5

Set id: 5e9e4dfd-4def-4756-9bba-d25068640101

Version: 3

Effective Time: 20200312

Search by Drug Name or NDC

NDC 29978-0587-01 Aquanaz 15; 400; 10 mg/1; mg/1; mg/1 Details

Aquanaz 15; 400; 10 mg/1; mg/1; mg/1

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 29978-0587-01 (29978058701)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 5e9e4dfd-4def-4756-9bba-d25068640101 Details

SPL UNCLASSIFIED SECTION

Active Ingredient.

Purpose.

Active Ingredient.

Purpose.

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,

KEEP OUT OF REACH OF CHILDREN.

Inactive Ingredients:

Other Information:

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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