Label: DECONEX IR- guaifenesin and phenylephrine hcl tablet
- NDC Code(s): 50991-736-02, 50991-736-90
- Packager: Poly Pharmaceuticals, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Drug Label Information
Updated January 27, 2024
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredients
- Purpose
- Active ingredients
- Purpose
- Uses
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Warnings
Do not exceed recommended dosage.
A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor.
Ask a doctor before use if you have
- a persistent or chronic cough such as occurs
with smoking, asthma, chronic bronchitis, or
emphysema, or if cough is accompanied by
excessive phlegm
- heart disease
- high blood
pressure
- thyroid disease
- diabetes
- difficulty in urination due to enlargement of the prostate gland
Ask a doctor before use if you are taking sedatives or tranquilizers.
Ask a doctor or pharmacist before use
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 the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
- a persistent or chronic cough such as occurs
with smoking, asthma, chronic bronchitis, or
emphysema, or if cough is accompanied by
excessive phlegm
- Directions:
- Other information
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DECONEX IR
guaifenesin and phenylephrine hcl tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50991-736 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 385 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg Inactive Ingredients Ingredient Name Strength FD&C YELLOW NO. 5 (UNII: I753WB2F1M) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) Product Characteristics Color green Score 2 pieces Shape OVAL Size 17mm Flavor Imprint Code POLY;716 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50991-736-02 12 in 1 CARTON 08/08/2016 1 2 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:50991-736-90 1 in 1 CARTON 08/08/2016 2 90 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 08/08/2016 Labeler - Poly Pharmaceuticals, Inc. (198449894)
