FDA Label for Axim Night Time - Liquid
View Indications, Usage & Precautions
- OTHER
- OTC - PURPOSE
- USES
- WARNINGS
- 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 Night Time - Liquid 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
Distributed by:
VIVUNT PHARMA LLC
8950 SW 74th. Court. Suite 1901
Miami, FL 33156-3178
Made in USA
www.vivunt.live
Otc - Purpose
Active ingredients (in each 30 mL dose cup) | Purpose |
---|---|
Acetaminophen 650 mg | Pain reliever/fever reducer |
Dextromethorphan HBr 30 mg | Cough suppressant |
Doxylamine succinate 12.5 mg | Antihistamine |
Uses
Temporarily relieves common cold/flu symptoms:
- sore throat
- minor aches & pains
- runny nose & sneezing
- headache
- fever
- cough due to minor throat & bronchial irritation
Warnings
Liver Warning
This product contains acetaminophen. Severe liver damage may occur if:
- adults and children over 12 years of age take more than 4 doses (30 mL each) in 24 hrs, which is the maximum daily amount for this product
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks daily 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
- to make a child sleep
Ask A Doctor Before Use If You Have
- liver disease
- glaucoma
- cough that occurs with too much phlegm (mucus)
- a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema
- trouble urinating due to enlarged prostate gland
Ask A Doctor Or Pharmacist Before Use If You Are
- taking sedatives or tranquilizers
- taking the blood thinning drug warfarin
When Using This Product
- do not use more than directed
- excitability may occur, especially in children
- marked drowsiness may occur
- avoid alcoholic drinks
- be careful when driving a motor vehicle or operating machinery
- alcohol, sedatives, and tranquilizers may increase drowsiness
Stop Use And Ask A Doctor If
- 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.
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
Taking more than the recommended dose (overdose) could cause serious health problems, including liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms
Directions
- take only as directed (see overdose warning)
- measure only with dosage cup provided and keep dosage cup with product
- mL = milliliter
- do not exceed 4 doses per 24 hours
- when using DayTime and NightTime products, limit total to 4 doses per 24 hours
adults and children 12 years and over | 30 mL every 6 hours |
children under 12 years | do not use |
Other Information
- Each 30 mL dose cup contains: sodium 10 mg
- Store at room temperature 15 - 30°C (59 - 89°F) and do not refrigerate
- Tamper evident: Do not use if shrink band is missing or broken
Inactive Ingredients
Citric acid, FD&C Blue #1, FD&C Red #40, flavor, glycerin, menthol, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum
Principal Display Panel
Compare to VICKS ®NyQuil ®
Cold & Flu active ingredients*
NDC 82706-012-01
AXIM - NightTime
COLD&FLU
Multi-Symptom Relief
- Pain Reliever
- Fever Reducer
- Cough Suppresant
- Antihistamine
Nighttime Relief
Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate
12 FL OZ (355 mL)
*This product is not manufactured or distributed by The Procter &Gamble Company, owner of registered trademarks Vicks® NyQuil®
* Please review the disclaimer below.