Label: AXIV SINUS SEVERE MUCUS- acetaminophen, guaifenesin, phenylephrine hydrocloride capsule, liquid filled
- NDC Code(s): 82706-020-01, 82706-020-02
- Packager: VIVUNT PHARMA LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated March 8, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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Uses
Temporarily relieves these symptoms associated with hay fever or other respiratory allergies, and the common cold:
- sinus congestion and pressure
- headache
- nasal congestion
- minor aches and pains
- helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
- temporarily reduces fever
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Warnings
Liver warning
This product contains acetaminophen. Severe liver damage may occur if you take
- more than 8 Softgels in 24 hours, which is the maximum daily amount for this product.
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
Allergy Alert:
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash
If a skin reaction occurs, stop use and seek medical help right away.
Do not use
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- 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.
- if you have ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if you have
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to an enlarged prostate gland
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- cough that occurs with too much phlegm (mucus)
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occur
- pain, nasal congestion or cough gets worse or lasts more than 7 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
- cough comes back or occurs with rash or headache that lasts
These could be signs of a serious condition
- Directions
- Other information
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL - AXIM Sinux Severe + Mucus 24
Compare Vicks® Sinex ™
Severe All In One Sinus + Mucus™ LiquiCaps®
active ingredients*
NDC 82706-020-01
AXIV Sinus Severe + Mucus
Cough & Congestion
Pain Reliever
Fever Reducer
Expectorant
Nassal DecongestantNON-DROWSY
Acetaminophen, Guaifenesin, Phenylephrine HCl
24 SOFTGELS** **Liquid-filled Capsules
*This product is not manufactured or distributed by
The Procter &Gamble Company, owner of the registered
trademarks Vicks® Sinex ™ Severe All In One Sinus + Mucus™ LiquiCaps®
-
PRINCIPAL DISPLAY PANEL - AXIM Sinux Severe + Mucus 4
Compare Vicks® Sinex ™
Severe All In One Sinus + Mucus™ LiquiCaps®
active ingredients*
NDC 82706-020-02
AXIV Sinus Severe + Mucus
Cough & Congestion
Pain Reliever
Fever Reducer
Expectorant
Nassal DecongestantNON-DROWSY
Acetaminophen, Guaifenesin, Phenylephrine HCl
4 SOFTGELS** **Liquid-filled Capsules
*This product is not manufactured or distributed by
The Procter &Gamble Company, owner of the registered
trademarks Vicks® Sinex ™ Severe All In One Sinus + Mucus™ LiquiCaps®
-
INGREDIENTS AND APPEARANCE
AXIV SINUS SEVERE MUCUS
acetaminophen, guaifenesin, phenylephrine hydrocloride capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82706-020 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 200 mg ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg Inactive Ingredients Ingredient Name Strength POVIDONE K30 (UNII: U725QWY32X) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) GLYCERIN (UNII: PDC6A3C0OX) FD&C RED NO. 40 (UNII: WZB9127XOA) D&C RED NO. 33 (UNII: 9DBA0SBB0L) GELATIN (UNII: 2G86QN327L) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) SORBITOL (UNII: 506T60A25R) Product Characteristics Color red Score no score Shape OVAL Size 22mm Flavor Imprint Code AXIV Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82706-020-01 2 in 1 CARTON 03/08/2024 1 12 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:82706-020-02 2 in 1 CARTON 03/08/2024 2 2 in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 03/08/2024 Labeler - VIVUNT PHARMA LLC (045829437)