FDA Label for Axim Daytime
View Indications, Usage & Precautions
- OTHER
- OTC - PURPOSE
- USES
- LIVER WARNING
- ALLERGY ALERT
- SORE THROAT WARNING
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- OTC - KEEP OUT OF REACH OF CHILDREN
- IF PREGNANT OR BREAST-FEEDING
- OVERDOSE WARNING
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- PRINCIPAL DISPLAY PANEL - AXIM DAYTIME CARTON
Axim Daytime Product Label
The following document was submitted to the FDA by the labeler of this product Vivunt Pharma Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
Product of India
Distributed by:
VIVUNT PHARMA LLC
8950 SW 74th. Court. Suite 1901
Miami, Florida. Z,C. 33156-3178
Otc - Purpose
Active ingredients (in each softgel) | Purpose |
---|---|
Acetaminophen 325 mg | Pain reliever/fever reducer |
Dextromethorphan HBr 10 mg | Cough suppressant |
Phenylephrine HCl 5 mg | Nasal decongestant |
Uses
Temporarily relieves common cold/flu symptoms:
- Nasal Congestion
- Cough due to minor throat and bronchial irritation
- sore throat
- headache
- minor aches and pains
- fever
Liver Warning
This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4,000 mg of acetaminophen in 24 hours
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
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
Sore Throat Warning
If sore throat is severe, lasts for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
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
- diabetes
- thyroid disease
- trouble urinating due to an enlarged prostate gland
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough as occurs with smoking, asthma, or emphysema
Ask A Doctor Or Pharmacist Before Use If You Are
taking the blood thinning drug warfarin.
When Using This Product
do not exceed recommended dose
Stop Use And Ask A Doctor If
- you get nervous, dizzy or sleepless
- pain 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
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
If Pregnant Or Breast-Feeding
ask a health professional before use.
Overdose Warning
In case of accidental overdose, seek professional assistance or contact a poison control center immediately.
Directions
- Take only as directed see - overdose warning:
- Do not take more than 8 Softgels in 24 hours.
adults & children 12 yrs & over | 2 Softgels with water every 4 hrs |
children 4 to under 12 yrs | consult a doctor |
children under 4 yrs | do not use |
Other Information
- Store at 20° - 25 °C (68 °- 77 °F)
- Read all product information before using
- Tamper Evident: Do not use if the foil printed on the blister is torn or ripped.
Inactive Ingredients
FD&C Red No. 40, FD&C Yellow No. 6, Gelatin, Glycerin, Methylparaben, Polyethylene Glycol 400, Povidone K30, Propylene Glycol, Propylparaben, Purified Water, Sorbitol, Titanium Dioxide
Principal Display Panel - Axim Daytime Carton
Compare to
VICKS ® DayQuil™
Cold&Flu LiquiCaps
active ingredients*
NDC 82706-001-01
AXIM - DayTime
COLD&FLU
Multi-Symptom Relief
- Pain Reliever
- Fever Reducer
- Cough Suppressant
- Nasal Decongestant
Non-Drowsy
Acetaminophen , Phenylephrine HCl,
Dextromethorphan HBr
24 SOFTGELS** **Liquid-filled capsules
*This product is not manufactured or distributed by
The Procter &Gamble Company. Vicks® DayQuil®
and LiquiCaps™ are registered trademarks of
The Procter and Gamble Company
* Please review the disclaimer below.