Label: AXIM NIGHT TIME - LIQUID- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate liquid
- NDC Code(s): 82706-012-01
- Packager: VIVUNT PHARMA LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 5, 2024
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
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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.
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
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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
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
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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®
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INGREDIENTS AND APPEARANCE
AXIM NIGHT TIME - LIQUID
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82706-012 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 650 mg in 30 mL DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 30 mg in 30 mL DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 12.5 mg in 30 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SORBITOL SOLUTION (UNII: 8KW3E207O2) SUCRALOSE (UNII: 96K6UQ3ZD4) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color red Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82706-012-01 355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/05/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 01/05/2024 Labeler - VIVUNT PHARMA LLC (045829437)