AXIM - DayTime Cold & Flu
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - PURPOSE SECTION
| 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
Warnings
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:
If a skin reaction occurs, stop use and seek medical help right away
- skin reddening
- blisters
- rash
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
These could be signs of a serious condition
- 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.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
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
| adults and children 12 years and over | 2 softgels with water every 4 hours |
| children 4 to under 12 years | consult a doctor |
| children under 4 years | do not use |
- Take only as directed (see overdose warning)
- Do not take more than 8 softgels in 24 hours.
Other information
- Store at 20° - 25 °C (68 °- 77 °F)
- Read all product information before using
- Tamper evident: Do not use if carton is open or blister unit is broken.
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
SPL UNCLASSIFIED SECTION
Product of India Distributed by:
VIVUNT PHARMA LLC 8950 SW 74th. Court. Suite 1901
Miami, Florida. Z,C. 33156-3178