Aquanaz Tablets

Aquanaz Tablets
SPL v7
SPL
SPL Set ID 5e9e4dfd-4def-4756-9bba-d25068640101
Route
ORAL
Published
Effective Date 2015-06-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (15 mg) Guaifenesin (400 mg) Phenylephrine (10 mg)
Inactive Ingredients
Fd&c Blue No. 2 Cellulose, Microcrystalline Silicon Dioxide Stearic Acid

Identifiers & Packaging

Pill Appearance
Imprint: PAC3 Shape: oval Color: blue Size: 15 mm Score: 1
Marketing Status
UNAPPROVED DRUG OTHER Active Since 2015-03-10

Description

Aquanaz Drug Facts.

Purpose

Cough Suppressant.


Medication Information

Purpose

Cough Suppressant.

Description

Aquanaz Drug Facts.

Ask A

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)

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.

Section 42229-5

Aquanaz Drug Facts.

Purpose.

Cough Suppressant.

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.

Active Ingredient.

Dextromethorphan HBr 15mg.

Other Information:

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

Inactive Ingredients:

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

Principal Display Panel

NDC 29978-587-01

NEW


Aquanaz

TABLETS


TRIPLE COMBINATION RELIEF:


Cough Suppressant : Dextromethorphan   HB R 15 MG

Expectorant : Guaifen e sin 400 MG

Decongestant : Phenylephrine   HCL 10 MG

100 Tablets


If Pregnant Or Breast Feeding

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.

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.

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.


Structured Label Content

Ask A (Ask a)

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)

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.

Section 42229-5 (42229-5)

Aquanaz Drug Facts.

Purpose.

Cough Suppressant.

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.

Active Ingredient.

Dextromethorphan HBr 15mg.

Other Information:

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

Inactive Ingredients:

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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 29978-587-01

NEW


Aquanaz

TABLETS


TRIPLE COMBINATION RELIEF:


Cough Suppressant : Dextromethorphan   HB R 15 MG

Expectorant : Guaifen e sin 400 MG

Decongestant : Phenylephrine   HCL 10 MG

100 Tablets


If Pregnant Or Breast Feeding (If pregnant or breast-feeding)

ask a health care professional before use.

Keep Out of Reach of Children (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.

Stop Use and Ask A Doctor If: (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.

Warnings: When Using This Product Do Not Exceed Recommended Dose. (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.


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