Label: AQUANAZ- dextromethorphan hydrobromide, guaifenesin and phenylephrine hydrochloride tablet
- NDC Code(s): 29978-587-01
- Packager: Capital Pharmaceutical, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated February 26, 2024
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredient.
- Purpose.
- Active Ingredient.
- Purpose.
- Active Ingredient.
- Purpose.
- Uses:
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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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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:
- Directions:
- If pregnant or breast-feeding baby,
- KEEP OUT OF REACH OF CHILDREN.
- Inactive Ingredients:
- Other Information:
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
AQUANAZ
dextromethorphan hydrobromide, guaifenesin and phenylephrine hydrochloride tabletProduct 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 unapproved drug other 03/10/2015 Labeler - Capital Pharmaceutical, LLC (831545541)